The Constitutional Court found No 6 / 2021 Coll.
The Constitutional Court found of 10 November 2020 sp. zn.
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6
FIND
The Constitutional Court
On behalf of the Republic
The Constitutional Court decided under sp. zn. Pl. ÚS 33 / 16 on 10 November 2020 in plenary composed of Judges Louis David, Jaroslav Fenyk, Josef Fiale, Jan Filip, Jaromír Jirsy, Tomáš Licenčník, Pavel Rychetský, Vladimir Sládek, Radovan Suchanek (Judge Rapporteur), Pavel Šámal, Kateřina Šimáková, Vojtěch Šimíček, Milady Tomková, David Uhlíř and Jiří Zemánek on the proposal of a group of senators, represented by JUDr. Jiří Nykodým, a lawyer, with the registered office of 17 November 230 / 19, Romans, on the abolition of the Act on public health insurance and the amendment of certain other laws, in the Chamber of the Czech Republic as a member of Parliament, as a member of the Parliament, as a member of the Parliament, as a member of the European Parliament, as a member of the Parliament, as a member of the court, as a member of the court of the court of the court of the court, of the
as follows:
I. The proposal to repeal Sections 70 to 78 of Act No. 372 / 2011 Coll., on health services and the conditions for their provision (Health Services Act), as amended, is rejected.
II. The proposal to repeal § 41a (1) of Act No. 48 / 1997 Coll., on Public Health Insurance and to amend and supplement certain related laws, as amended, is rejected.
Reasons
Subject matter
1. On 5 October 2016, the Constitutional Court received the submission of a group of twenty senators (hereinafter referred to as "the appellant '), represented by the lawyer, proposing the implementation of the procedure under Article 87 (1) of the Constitution of the Czech Republic (hereinafter referred to as" the Constitution') on the application for annulment of Sections 70, 71, 72, 73, 74, 75, 76, 77, 77a and 78 of Act No. 372 / 2011 Coll., on health services and the conditions for their provision (the Act on Health Services), as amended, and § 41a (1) of Act No. 48 / 1997 Coll., on Public Health Insurance and the amendment of certain related Acts, as amended (hereinafter referred to as "Act No 48 / 1997 Coll." or "Public Health Insurance Act '). On 12 May 2020, the appellant also proposed the annulment of Sections 71a, 71b and 71c of the Law on Health Services (see paragraph 18 below).
2. All the contested provisions of the Health Services Act belong to its sixth part of Title Three, entitled the National Health Information System (hereinafter referred to as "NZIS '), and the appellant proposes to repeal the entire legislation contained in this Title. The contested legislation creates the NZIS as a single national public administration information system intended for the Law on Health Services, which is listed in Article 70 (1), i.e. for the processing of data on the health status of the population, the activities of health service providers and their economy, health professionals and other health professionals, and for the reimbursement of health services paid from public health insurance, the management of the National Health Registers, as listed in the Annex to the Act, but not including the provision of information to international institutions, the National Register of Health Service Providers, the National Health Service Service Registry (hereinafter referred to as" NRZP') and the National Register of Health Services, as well as for the processing of data so obtained for statistical purposes, the implementation and the provision of statistical information, including the provision of information on the health status of the international institutions, the National Register of health service providers, the needs and the consumption and consumption of health services and the health services and the consumption and the health services, and the costs of health services, for the research and research and research and research and research related to be carried out. The rules of cooperation of the Ministry of the Interior, the Police of the Czech Republic, the Czech Statistical Office and the Institute of Health Information and Statistics of the Czech Republic (hereinafter referred to as the "Institute") are also included in the provision of data from basic registers and other information systems of the public administration.
3. The contested provision of Section 41a (1) of Act No 48 / 1997 Coll. allows the Institute to establish and update annually the list of groups of hospitalisation in acute bed care related to diagnosis, their relative cost, the rules on the inclusion of hospitalisation in those groups and the methodologies related to the reporting of paid services in acute bed care. The current data and methodologies thus obtained are then required to be transmitted by the Institute to the Ministry of Health (hereinafter referred to as "the Ministry ') within 90 days of the end of the calendar year. This provision also provides that the rules governing the inclusion of hospitalizations in those groups are maintained by the Institute in a computer program which it provides to the Ministry at the same time as those data.
4. According to the appellant, the contested regulation contradicts the constitutionally guaranteed right of everyone to protect against the unlawful collection, publication or other misuse of data concerning his or her person pursuant to Article 10 (3) of the Charter of Fundamental Rights and Freedoms (hereinafter referred to as "the Charter '), the right to engage in other economic activities under Article 26 (1) of the Charter and the right to judicial protection under Article 36 (1) and (2) of the Charter.
Arguments of the appellant
5. First of all, the appellant notes that the NZIS is a catalogue of registers in which, according to the subject criterion, information is collected on health service providers, health workers, patients and their diagnoses and on the services provided. In fact, however, it did not bring the registry into life the Health Services Act, but it is a historical relic of centrally managed health care, where the right to privacy in the form of data protection was of absolutely marginal importance. Even later, in the 1990s, the issue of registers was not given much attention. It was only in 2001 that existing registers were formally anchored in the then applicable Act No. 20 / 1966 Coll., on the care of the health of the people, with regard to the adoption of Act No. 101 / 2000 Coll., on the Protection of Personal Data and on the Amendment of Certain Laws ("the Act on the Protection of Personal Data ') and the Convention on the Protection of Human Rights and the Dignity of Human Being in the context of the application of biology and medicine: the Convention on Human Rights and Biomedicine (No 96 / 2001 Coll.), as well as the need to adapt to European data protection against entry into the European Union (" EU'). In 2011, the original solution of registers without conceptual changes was more or less "tilted" from the repealed People's Health Care Act to the Health Services Act. According to the appellant, the register management methodology thus retains a "overall paternalistic spirit," where minimal consideration is given to protecting the rights of those on whom data are processed, including fundamental rights.
6. The appellant recalls that the regulation of the registers contained in the Health Services Act was submitted to the Constitutional Court at the time of the legalisation of the Act, which, by the finding of 27 November 2012, sp. zn. It concluded that the relevant legislation provides for public access to the processed personal data to the extent and for a period which cannot be justified by any constitutional purpose and cannot be attributed to the authorisation of certain bodies whose personnel are to be defined by the Ministry of Access Rights.
7. The legal reasons that led to the abolition of NRZP, according to the author, also affect patient registers and at all certain aspects of the management of NZIS. It is true that it was formally proposed to review the Health Services Act as a whole in the proceedings of the Pr. However, on any later proposal, the Constitutional Court expressly stated that a finding beyond the scope of the NRZP review carried out did not create an obstacle to the decision-making case in respect of Sections 70 to 78 of the Health Services Act and therefore nothing prevents a new proposal from being made against those provisions.
8. The wording contained in the statement of reasons for the Constitutional Court's finding, sp. zn. Pl. ÚS 1 / 12, containing the grounds for considering legal protection claims in the collection of data, shows that the Constitutional Court would critically assess other provisions concerning NZIS and that it should be a legislative warning that if the possibility of rectifying the situation in the preparation of a new register of health professionals would have to cancel the next one in the future. However, the Ministry disregarded this warning when it submitted an amendment to the Act, published as Act No. 147 / 2016 Coll., amending Act No. 372 / 2011 Coll., on Health Services and the Conditions for Their Provision (Health Services Act), as amended by the later Act, which introduced the repealed NRZP completely in the spirit of prior adaptation. In addition, some minor changes were made to the NZIS settings, but in view of the problematic determination of the extent of data collected, their protection, the definition of the range of persons who have access to them, etc., the rules remained unchanged. On the contrary, another register - the National Register of Paid Health Services (Section 77a of the Health Services Act) - has been added, thus further intensifying data collection. The Ministry was entrusted with this amendment to establish the Institute (Section 70 (3) of the Health Services Act) as the administrator of the NZIS. These changes not only did not remove the constitutional deficit of the original legislation, but rather deepened it. For the "setup" of the NZIS, the author states that it attacks primarily the concept of data collection into the system itself when it is guided by not a desirable idea to collect data on diseases but primarily collect data on patients. In the proportionality test, the contested regulation would not, in its view, pass the test.
9. The appellant points to certain provisions of the contested regulation which, in its view, are key, namely Sections 70 (2) (a) and 71 (3), (4) and (12) of the Health Services Act. According to the first provision, for the processing of personal data in the NZIS referred to in points (b) and (c) of paragraph 1 (i.e. for the management of the registers and for the processing of data in them), the patient's listed data, i.e. the data required to identify him, his medical status related to the disease and his treatment, as well as the identification data of the health service provider and the last employer with whom the patient who developed the occupational disease worked, are transmitted without the consent of the data subject. In addition, the appellant argues that all the objectives set out in Section 70 (1) of the Health Services Act can be achieved without identifying patients only on the basis of non-personal, anonymous data. The purpose of keeping individual registers and processing data in them, according to the author, is completely useless and does not legitimise anything. The record keeping itself is an intervention in the right to information self-determination and therefore cannot be a purpose in itself.
10. As regards the provisions of § 71 (3) and (4) of the Health Services Act, which define the extent of the data collected, the applicant considers that most of these data are not related to or not relevant to the health condition and therefore unnecessary [they include, for example, data on the place, district and / or state of birth, nationality, place and duration of residence, limitation of incapacity, name, surname, surname and birth number of the father, mother or other legal representative, family status, date of his change and place of marriage, date and place of establishment of registered partnership, name, surname and birth number of the spouse or registered partner and child, or of the semen referred to in paragraph 3 (o)]. According to the appellant, this is sensitive personal data and it is unnecessary to expose their subjects to the risk of abuse or unauthorised access to it.
11. The amendment of the rules on the subsequent handling of collected data contained in § 71 (12) (from 24. 4. 2019 in paragraph 11) of the Health Services Act, the appellant contends that there is a lack of further clarification as to who specifically has access to individual data, how they will be treated, what the data subjects have to guarantee against unauthorised handling, what the remedy mechanism is if certain data are to be processed without cause or justification, etc. The only correction is the rule contained in Paragraph 71 (11) (now paragraph 10), according to which, in a particular case, only such data which are necessary to fulfil the task can be used from the data provided or collected. The appellant also considers that there is a complete lack of regulation of the possibility for the data subject to request that some of the data collected be deleted.
12. As regards NRZP, the contested regulation left its purpose, as discussed by the Constitutional Court's finding, sp. zn. If this register is now constructed as a non-public register, the only reason for keeping it in such a way that the data in this register can be identified with specific persons has disappeared. According to the appellant, the range of data collected is also disproportionate and unnecessary. At the same time, the new regulation failed to establish the time limit for which the data on healthcare workers would be registered and did not lay down any rules on their erasure or the conditions under which the deletion of data could be sought by their entity itself.
13. If so-called patient registers are concerned, according to the appellant, they are created and implemented entirely, regardless of the consent or consent of the person concerned by the data. The author considers it legitimate to collect statistical data, i.e. anonymised, not personal, which are processed for the needs of the Ministry and which can be accessed by private persons (scientists, health service providers, patient public); the patient's consent is not required for this collection, because the data transmitted cannot identify a particular individual. By contrast, the collection of sensitive data on the course and outcome of treatment is constitutionally correct only with the consent of the patient (although also in the form of consent foreseen with the possibility of opting-out) and without it only in exceptional cases where there is a strong public interest in collecting data on targeted treatment of a serious disease with a narrow legal purpose and with strict security. However, the legislature did not choose a more gentle way of assuming that conditions and rules were laid down to express the opposition of the persons concerned to the collection of data and to the procedure leading to their deletion. The law did not mean at all to modify any possibility of achieving the deletion of selected data at the request of their subject. Similarly, the law does not establish any safeguards against unauthorised access to data and their possible misuse, or any remedies if this were to happen. The reason against accepting the collection of this type of data without the consent of the patient is that individual registers are linked by the introduction of the National Register of Paid Health Services, which brings together personal data. Such a huge database of data accumulating is being developed for a very long time without it being clear that this is necessary. In particular, the range of persons who have access to these data is insufficiently and vaguely defined, no safeguards are set in the law against abuse, at least in the form of confidentiality or sanctions. According to the appellant, the management of such a database as non-anonymous in addition to normal medical documentation is unnecessary, inappropriate and inconsiderate. There is not the only reason that an interest in creating such a database would outweigh the right of patients to decide on the handling of data on their person. If the purpose of collecting patients' data is to manage the quality of hospitals, the registers are not and should not be intended for this purpose, since "individual quality management 'is intended for other legal instruments and institutions, namely health insurance companies (and their review doctors), hospital authorities, regional authorities, professional chambers, quality assessment bodies (ministerial accredited bodies) and the State Institute for Drug Control (SÚKL). The role of the Ministry is to" oversee "these processes and ensure their functioning, not to substitute their functions by establishing another huge database of data for quality management.
14. As regards the National Register of Paid Health Services, the applicant argues that when it comes to collecting data for the purposes of managing the reimbursement of health services, the system of payments is based on health insurance companies and ensuring the availability of paid care and financing of the contractual network of providers is their responsibility, not the Ministry. In a situation where the reimbursement data is collected by health insurance companies, there is no legitimate reason to duplicate the database in the form of the said health register. In addition, the appellant is convinced that it is not possible to "outsource" the supervision of payments or the creation of payment mechanisms from a politically-led Ministry to an incompetent statistical office and to equip it for this purpose with extensive access to personal data. The desired target can be achieved without data being collected without the consent of their entities.
15. Finally, the appellant also points to Article 78 of the Health Services Act, which entrusts the substatutory regulation to establish the listed details of the management of health registers. It refers to point (d), according to which these are also elements of the application for access to and revocation of personal data and other data held in medical registers. According to the appellant, that authorisation is insufficient in a situation where Article 73 (2) of the Health Services Act defines the range of persons authorised to access the data kept in the medical registers only widely and indefinitely so as to be a "authorised worker '. The precise definition of the range of persons entitled to access data is crucial in terms of the protection of constitutional law. According to the appellant, the Health Services Act does not define" authorised worker', so it actually leaves it to a substatutory law, which is unacceptable.
16. Paragraph 41a (1) of Law No 48 / 1997 Coll. states that its abolition must be a necessary consequence of the deregulation of the NZIS legislation. At the same time, the appellant considers that the outputs of the Constitution created on the basis of data processed in breach of the fundamental rights of the operators concerned must necessarily also be constitutionally defective. In this part of the proposal, the appellant also criticises the absence of legal rules for the calculation of costs, which means in particular that: it is not clear whether or not the investment costs of health service providers will also be included; the input data will be burdened by an error rate resulting from the adaptation of providers to agreed remuneration supplements each year when providing and reporting care; in the case of medical devices, there is no sufficient regulation of their remuneration, it is not so clear whether the market price or the reported numerical price will be the eligible cost; for pharmaceuticals, it is not clear how different producer prices, margins, reported prices and reimbursement between certain producers and health insurance companies are taken into account in the cost calculation; it is not clear for the outstanding provisions on qualifications of doctors and other health professionals and for the marginal differences in personnel security between the centre and the regions how personnel cost will be calculated. Nor is the relationship between the Institute's activities in creating the IR- DRG classification of hospitalised patients (International Accuracy Groups related to diagnosis - hereinafter referred to as "IR- DRG ') and the determination of the relative costs of the groups to the existing methodologies for calculating health performance payments, i.e. the existing conciliation processes, to the creation of a list of health performance with points, to the issuing of reimbursement orders, to the process of making drug payments or to individual reimbursement supplements. In the present provision of the Act, there are no criteria for determining the costs to be followed by the Institute, any rules on the process of protecting the rights and claims of providers with the possibility of appeal or any measures against the nature and bias of the Institute as processors of the relevant data. The Institute thus intervenes in the competition of certain health service providers, as their management is directly affected by the calculation of costs without, however, being able to benefit from any institutionalised protection within the meaning of Article 36 (1) and (2) of the Charter. In this context, the appellant points out the finding of sp. zn.
17. Finally, the appellant proposed to defer the enforceability of the finding to a period appropriate for the adoption of new legislation which would comply with constitutional requirements.
18. In its submission to the Constitutional Court on 12 May 2020, the appellant supplemented and extended its petition with regard to the amendments to the Health Services Act and Act No. 48 / 1997 Coll., implemented by Act No. 192 / 2016 Coll., No. 290 / 2017 Coll., No. 282 / 2018 Coll. and No. 111 / 2019 Coll., which were adopted after the submission of the proposal. As regards the impact of these amendments, the appellant stated that the reasons for the derogatory proposal are that the whole part of the Health Services Act governing NZIS constitutes a comprehensive set of rules from which individual provisions can be removed without affecting the whole are difficult. It is therefore proposed for cancellation as a whole. It is clear that none of the amendments made touched either the overall concept of data collection into the system in the aspects criticised by the author or the individual sub-rules for setting up individual registers. Thus, the contradiction of setting the NZIS with the constitutional rules continues, since none of the authorised changes responded to any of the reservations raised by the applicant against the health database. With regard to Article 41a (1) of Act No. 48 / 1997 Coll., even after the amendment by Act No. 192 / 2016 Coll. (correct: Act No. 282 / 2018 Coll. - Note of the Constitutional Court) does not change its interdependence with the NZIS legislation, the provision only received minor terminology changes in the designation of the Constitution. The amendment did not change the fact that the concept of the system is guided by the idea of collecting data primarily not about diseases but about the sick. Without change, the collection of sensitive non-anonymised data on the course and results of treatment of specific patients remained without their consent. Exceptional cases are no longer defined where the extremely strong public interest in collecting data on targeted treatment of serious diseases outweighs the requirement for the consent of the data subject. Without change, there remains a vague definition of the range of persons who may be familiar with these data as well as the absence of safeguards against data abuse (the author points in particular to the current successful attacks by hackers on health care facilities' information systems). Without changes, the collection of patient data to manage the quality of hospitals and the reimbursement system was also defective when patients' data were already collected into other systems for these processes, and the creation of another database of patient data - without their consent - is redundant. The amendments only marginally intervened in Section 70 of the Health Services Act when it was added to paragraph 3 that the Institute was headed by the Director and two additional organisational elements of the State transferring data to NRZP were added to paragraph 4. The amendments remain unaffected by the problematic provisions of Sections 71 (3) and (4) of the Health Services Act, which sets out the scope of the personal data provided to the Institute database. The NRZP also remains unchanged in terms of critical aspects, on the contrary the amendment carried out by Law 111 / 2019 Coll. extended the collected data by further, namely the number of the diploma, the type of employment and the extent of the weekly working time and the entries on the list of members of the chamber. In addition, the Ministry of Labour and Social Affairs has obtained access to the data after the amendment, as well as to persons who transmit data to the registry to the extent of these transmitted data. Thus, both the scope of the database and the range of people to whom it is accessible are increasing further. In addition, the amendments did not bring any change to the alleged inconsistency of patient registers with fundamental rights, but Amendment 111 / 2019 Coll. added information on the patient's death to the data provided by the Institute. Otherwise, the database shall continue to be maintained without the patient's consent, as non-anonymised, without guarantees of protection against unauthorised access and misuse of data. The current reservations remain with regard to Section 77a of the Health Services Act; also in this case, the processed data was extended by Act No. 290 / 2017 Coll. with data on the sex of insured persons and the village code address of the insured person's residence. The replacement of the insured person's identification number by an agent identifier of a natural person (AIFO) is a change in "cosmetic '. Article 78 of the Health Services Act was also unaffected by the amendments. The appellant therefore" only technically supplemented "the legislative amendment of the" petit "by proposing to repeal also Sections 71a, 71b and 71c of the Health Services Act.
Proceedings before the Constitutional Court
19. The Judge-Rapporteur, pursuant to Articles 42 (4) and 69 of Act No. 182 / 1993 Coll., on the Constitutional Court, as amended, (hereinafter referred to as the Law on the Constitutional Court), sent the motion to Parliament as a party to the proceedings and to the Government and to the Ombudsman as authorities entitled to intervene. At the same time, pursuant to Article 48 (2) of the Law on the Constitutional Court, he requested the expression of the Ministry, the Office for the Protection of Personal Data (hereinafter referred to as "the Office '), the Institute, the Czech Medical Chamber (hereinafter referred to as" the CLK'), the General Health Insurance Company of the Czech Republic (hereinafter referred to as "the Office of the World Health Organization in the Czech Republic ') and the Office of the World Health Organisation (hereinafter referred to as" the Office of the WHO').
Observation of Parliament's chambers
20. The Chamber of Deputies, in a statement signed by its President, summarised the course of the legislative process in which the draft law on health services was approved, including the amendments adopted. These included amendments to the Health Committee, which, inter alia, covered Sections 70 and 73 to 78. Following the rejection of the bill by the Chamber of Deputies, the Chamber of Deputies maintained its approved text.
21. Furthermore, the Chamber of Deputies summarised the course of the legislative process in which Act No. 147 / 2016 Coll. was adopted, by which the provisions of Sections 76 and 77, including the new Section 77a, were re-incorporated into the Health Services Act and the provisions of Sections 70 to 75 and 78 were amended. The new Section 77a was inserted into the law on the basis of an amendment by Mr Pavel Antonín (the amendment also concerned Article 78 of the same law), presented in a detailed debate at second reading, with the guarantee committee's resolution recommending the approval of the bill, including this amendment. That's what happened in the third reading.
22. In conclusion, the Chamber of Deputies stated that the draft laws of the House of Deputies had been approved by the two chambers of Parliament, the laws were signed by the relevant constitutional authorities and properly declared.
23. The Senate, in its observations signed by its President, first briefly summarized the course of the legislative process in which the draft law on health services was discussed. On the contested provisions governing the NZIS, the Senate referred to its previous observations in the case sp. zn. However, the Chamber of Deputies has renegotiated and approved it.
24. The Senate also described the course of the legislative process in which Act No. 147 / 2016 Coll. In its plenary session in the Senate, in addition to a positive assessment of the draft law, a number of comments were made, in addition to the possibility of cumulative use of patient health data and other relevant health data for patient treatment and simplification of the administrative agenda of doctors and health service providers, which rejected the draft law in the form presented. Their essence was to criticise the concentration of "data on health problems and health situations of all citizens of the Czech Republic in one place, with the fact that the data is always linked to a specific birth number, meaning to a specific individual" and that it is not processed in an anonymous form. A doubt was also expressed on the accuracy of the data management of the data subject in the NZIS without the consent of the data subject. After the debate, the Senate approved the bill.
Government observations
25. On 16 November 2016, the Constitutional Court received, within the legally prescribed deadline, the notification of the Government, signed by the Minister without a portfolio (Minister for Human Rights, Equal Opportunities and Legislation), that, on the basis of the Government's resolution of 1017, it enters the proceedings, proposes the rejection of the proposal and authorises the Minister for Health to represent it in the proceedings. With that resolution, the Government also approved its comments on the proposal.
26. At the outset, the Government stated that it considered its involvement in the proceedings necessary not only because of the need to refute the claims contained in the proposal, which it considers to be unfounded, but also considers as an opportunity for the public defence of the appropriateness and necessity of the contested legislation, as well as its rationality and constitutional conformity.
27. In the view of the Government, the appellant proposed the abolition of Title III in Part Six of the Health Services Act (i.e. Sections 70 to 78), which contains comprehensive legislation on the processing of data on the health status of the population, on the activities of providers and their economy, on health professionals and other health professionals, and on the reimbursement of health services paid from public health insurance - all of this through NZIS, or the so-called national health registers, the National Register of Health Services, and the National Register of Paid services, would necessarily lead to the complete liquidation of NZIS, and thus to the de facto liquidation of any centrally controlled collection of health data. In this context, the Government recalls that the provisions in the Health Services Act are the "only legal standard 'governing the controlled central collection of health data while maintaining cyber security. The Government believes that, in the event of the deregulation of the contested provisions of the Health Services Act, there would inevitably be chaos in collecting and processing data for health care, because it is clear that more (many) sites would accumulate and interpret data - but without any legal regulation and central methodological support. Another logical impact of this act would be, inter alia, the full inhibition of the quality and availability of medical care, the impossibility of monitoring population health indicators and the de facto impossibility of assessing the performance of the healthcare system in individual regions.
28. The Government therefore considers that, if the application by the Constitutional Court (including the application for the postponement of the enforceability of the derogatory finding) were complied with, there would be a de facto impossibility of central monitoring of the development, quality, safety and availability of healthcare. In this context, the Government recalls that, in addition to the right to information self-determination, according to Article 31 of the Charter, everyone has the right to health protection and citizens have the right to free health care and medical supplies under the conditions laid down by the law under public insurance. The Health Services Act and the Public Health Insurance Act ensure equal access to controlled and quality health care. Only the existence and possibility of processing complex data will allow these rights to be fulfilled and ensured in the long term. The contested legislation pursues a single and fundamental objective: to increase the information value of NZIS by using existing data in the health sector - exclusively data generated by public health insurance services.
29. As regards the appellant of the raised question of the "setup 'of the NZIS, the government considers it necessary to emphasise first of all that the primary purpose of NZIS's existence is not the collection and processing of patients' personal data, as evidenced above all by the fact that all analyses of data collected in the NZIS are conducted with fully anonymous and aggregated data. Its purpose is to monitor the parameters of care; However, in order to achieve this, the government believes that the processor of such data must be able to assign the care to a particular patient - but it is not in any way identified for the purpose of analysing the collected data (i.e. it is not possible to identify the data subject).
30. In this context, the Government also recalls that the way NZIS was created and its parameters were designed with the utmost respect for the protection of personal data and the rules of modern cyber security. All the parameters of the NZIS were also consulted and properly discussed not only with the professional companies (sc. Czech Medical Society Jana Evangelist Purkyně, sc. - note of the Constitutional Court) and the professional chambers of industry, but also became the subject of a wide and open discussion throughout the legislative process. In addition, the methodology of all registers in NZIS is based on recommendations and standards of international organisations (e.g. EUROSTAT, OECD, WHO).
31. Clear conditions are determined by the legislation contained in the Health Services Act, the purpose of their collection and processing is explicitly defined and the period of retention is laid down by law as necessary. Their processing is perfectly reasonable and accurate. Since data are processed without consent, priority is given to value considerations to the public interest, thereby limiting the individual's right to information self-determination in order to fulfil another of its rights under Article 31 of the Charter.
32. As regards the appellant's argument, based on the Constitutional Court's finding, Pl. ÚS 1 / 12, the Government states that it considers it to be at least misleading as it concerned NRZP, which was conceived as public. That finding cannot therefore, in the view of the Government, be applied either to the patient registers or to the management of NZIS, since their legislation now under appeal fully respects the right of health workers to information self-determination and the new NRZP is established as a completely private, reference, agenda system. The Law on Health Services also clearly defines the rights of access to the register or to the group of authorised workers under explicit conditions, contrary to the Constitutional Court's repealed NRZP legislation.
33. The author's claim that the generally collected aggregated data in the so-called health care providers' reports (State Statistical Service) are fully sufficient is, in the view of the Government, incorrect. These reports allow only a rough epidemiological view of the system and, moreover, far from all major diseases and health problems. This data also does not allow for an exact quality assessment and a representative assessment of the effectiveness of medical care resources. If central control of the medical system could only work with these data, it would mean a return to the 1970s. This way of collecting data would also bring a completely unmanageable administrative burden on health professionals.
34. In the view of the Government, the claim that data collected to manage the quality of hospitals are collected by other institutions through other legal instruments is purposeful, because it is in gross conflict with the fundamental principle of quality assessment of healthcare, i.e. it must be a transparent and objective system based on objective (reference) data. The NZIS data are indeed such a system, since the quality of care cannot be completely objectively assessed by the founder. There is also a need for a representative comparison of care at the level of the founder or region with the national reference standard - only a complex NZIS system can offer such comparison. This is how the NZIS feels about SÚKL and health insurance companies.
35. NZIS last but not least allows the effective use of existing data sources for a national representative assessment of health care (without changing the rights and obligations of health insurance companies in any way) and enables the effective implementation of the Ministry's supervisory obligation over health insurance companies, and thus mediate over the entire public health service system.
36. To the author of the personal data protection issue in NZIS, the government states that the purpose of collecting the birth numbers or numbers of insured persons in the NZIS registries is not to identify a particular individual - in addition, it is not possible to deduct a complete identification from only one such data. The whole Czech health service with more than 29 000 health service providers uses the social number and the number of the insured person as a link (link) code between different records of the same person on repeated reporting over time. This is also the case with existing health registers, such as the National Cancer Registry, founded in 1976, collecting reports from thousands of reporting agents over time. If there is no tool to link such a system to the individual, it will not be possible to evaluate the success rate of treatment, the availability of follow-up or palliative care, or the results of patient survival. Therefore, it cannot be accepted that, for example, an exact evaluation of the determinant of the health of the Czech population, the quantification of the assigned funds for the treatment of specific diseases in relation to achieved results, etc., can be achieved by other means. The ability of health registers and NZIS as a whole to connect records over time is an essential condition for evaluation of treatment.
37. NZIS does not use and does not need comprehensive identification of the individual when collecting and processing data or during analytical procedures. Therefore, complex personal data are not collected in any NZIS registry at the same time to enable identification - e.g. triad name, date of birth and birth number. The number and number of the insured person is used only to link the individual records. In any case, the identification of a specific person is no longer necessary and is no longer necessary for the actual processing of data in the NZIS; all NZIS outputs are aggregated and do not allow direct or indirect identification of a particular person. The transmission of data to providers and health insurance companies is then one of the basic functionalities of the NZIS. In this way, processes are implemented to enable providers to compare the results and quality of their own care with total, i.e. aggregated national or regional data. Similarly, synchronisation and data transmission from the National Register of Providers allows health insurance companies to monitor the network of providers effectively.
38. In addition to the provisions of § 71 (3) and (4) of the Health Services Act governing the scope of the data collected, the Government adds that these are sub-records of specific registers, not of data collection. This is also evident from the officially published methodology for NZIS registries. The record of the place of birth and citizenship is part of selected department statistics; the place of residence is indicated as a mandatory part of the statistics on deceased persons; information about parents or partners is an internationally collected entity in statistics on congenital developmental defects; information on the limitation of competence (incapacity) is part of the register of drug use and substance abuse. In all cases, these are very serious agendas in which the Ministry monitors the data effectively indispensable for a number of successive agendas of its or other state institutions and also for the needs of international cooperation. In any case, therefore, it is not possible to talk about the flat monitoring of the above parameters in all registers forming the NZIS.
39. As regards the lack of the possibility of a body collecting and processing personal data, the Government states that the possibility of random deletion would be contrary to the basic principles of statistical monitoring of the health status of the population, the quality of care and its economic efficiency. The result would be a chaotic and completely unrepresentative data source. Only distorted conclusions would then arise from distorted data, which would necessarily lead to errors in the management of care, in the evaluation of its availability or quality. It is therefore a requirement that would make it impossible to evaluate the quality of care accurately and ultimately harm patients. The inadmissibility of the deletion of data on request and the associated restriction of the right to information self-determination provided for by the Charter is therefore legitimate, according to the Government.
40. In order to re-establish NRZP, the Government states that the register is the basic and management register of any functional system "eHealth '(in this context, the government recalls that, due to the absence of long-term series of reference data on workers, there are no precise data on capacity distribution in the healthcare system). In the case of (re) cancellation of NRZP, databases collecting the same data are likely to arise in a partial way from different offices and institutions, which will only increase the risks of their misuse.
41. According to the Government, the contested NRZP legislation fully respects the finding of the Constitutional Court, sp. zn. Pl. ÚS 1 / 12, as it designs this register as a reference and agendas system which is not public. The purpose of the establishment of the register has also shifted substantially from the previous, Constitutional Court-annulled legislation - to the "eHealth 'proceedings, where such a system cannot replace any other system or register of professional chambers. The government is therefore convinced that data collection in NRZP cannot be described as redundant.
42. On the issue of patient registries, the government states that health registers are the backbone of the NZIS and as such are indispensable for many medical segments. For example, the author mentioned by the National Hospital Registry is the only source of data to assess the development, burden, availability and quality of bed care. However, the reason for this register is in no way to change the supervision of payments or to modify the status and role of health insurance companies. The reason for its existence is the need to use existing and regularly collected care data paid from public health insurance for comprehensive analyses of the health status of the population, the morbidity and its risks, the availability of care and its quality, as well as for analyses of weaknesses in the network of health service providers. If the register in question had been abolished, the partial hospital information systems in more than 350 hospitals could not replace it. At the same time, hospitals themselves would lose the opportunity to compare their results to total.
43. The objection to the uncertainty of the definition of the heading of persons entitled to access the data held in the health registers is that the heading of authorised persons (so-called authorised workers) is clearly laid down by law (Section 73 (2) of the Health Services Act) and does not leave it to the implementing legislation, as stated by the appellant. The Implementing Decree, within the meaning of Section 78 of the Health Services Act, provides, inter alia, only for the details of the application for access to and revocation of personal data and other data held in medical registers.
44. On Article 41a (1) of Act No. 48 / 1997 Coll. the Government stated that the data collected by it was based on voluntary obligations and is enshrined in contract. As regards the appellant's assertion that the Institute is interfering with the free competition of providers, the Government notes that the Institute is not an administrative body but is an organisational body of the State of which the Ministry is the founder. Any decision taken by the Constitution is therefore revisable on the basis of a complaint lodged by the Ministry whose decision on the complaint can be examined in the administrative judiciary.
Position of the Ministry of Health
45. Although the Constitutional Court has received observations from the Government represented by the Minister for Health, it considered it necessary that the Ministry should also provide its observations on the application to initiate the procedure, in particular to indicate for what purpose the personal data referred to in Sections 70 (2), 71 (1) to (5), 7 and 9), 74 (1) and (2), 76 (1) and 77a (3) of the Health Services Act to the NZIS are being transmitted individually to each of these data. However, the Ministry did not provide its comments even after the repeated call.
Communication from the Ombudsman
46. The Ombudsman informed the Constitutional Court that she had decided not to exercise her right to intervene.
Expression of the Office for the Protection of Personal Data
47. The Authority notes, first of all, that it does not object to the very introduction and existence of a system of health registers which benefit from the current possibilities of technological development for the health and well-being of man in the broadest sense. The purpose of introducing health registers should undoubtedly be to improve the conditions for providing health care through, for example, optimisation of health systems and the effective allocation of funds collected in the health insurance system. It is the health sector that has an extremely high potential for using the new possibilities that information technology brings. However, the Office requires that the use of new technologies and data in health care be linked to the protection of personal data and privacy and data protection requirements. It is based on the fact that the rapid pace of technological change and globalisation has changed the scope and manner of collection, use and access to data from the ground up. It is a fact that there is an exponential increase in the volume of data collected. This information is widely used in the company, for example for different types of analysis. Data file analyses typically have health or health policy applications, which can be used to combat diseases. Data processing is of great importance to society as a whole, and it is even known that many health and health problems can only be addressed in this way in the future. These trends can be characterised by the fact that the digital and physical world is currently interconnected. However, this may also involve numerous risks. If they do not contain large volumes of collected data, they do not pose any risks to the protection of personal data. However, most of the data currently generated includes personal data and extensive data files increase the risks to human privacy and the protection of personal data. The value of the information lies not only in its initial purpose but in its secondary use, i.e. processing for purposes other than those for which it was originally collected. When collecting large amounts of data, threats to personal data and privacy may occur, but also omission of ethical issues, human dignity and individuality.
48. Large-scale data are also referred to as a potential risk in Regulation (EU) 2016 / 679 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data and repealing Directive 95 / 46 / EC (General Data Protection Regulation) - ("the Regulation '). The Regulation does not propose the right to the protection of personal data as absolute, but states that it must be assessed in the context of its function in society and, in accordance with the principle of proportionality, it must be balanced with other fundamental rights (see its preamble).
49. Since the finding of sp. zn. Pl. ÚS 1 / 12 refers to the principles on which the Convention on the Protection of Persons with regard to Automatic Processing of Personal Data (No 115 / 2001 Coll. m.) and now no longer in force to Directive 95 / 46 / EC of the European Parliament and of the Council on the Protection of Individuals with regard to the Processing of Personal Data and on the Free Movement of Such Data ("the Directive ') are defined by the Regulation to assess the proposal for a relevant change of the legal framework as from 25 May 2018.
50. As regards health registers, in general, the fact that they are based on the collection and use of a large number of health data is essential from the point of view of privacy. These data are considered sensitive and are often considered more sensitive by natural persons than other data. A number of commercial and other operators use or have an interest in using so-called profiling, a distinction that can also be based on the use of health data. This may be manifested in a number of situations, such as the negotiation of a bank loan, the provision of a mortgage or the search for employment, or an individual may be exposed to social stigmatisation in conjunction with mental illness. It is the leaks of sensitive data in health care that are one of the biggest issues of data security. Health data are extremely valuable, even on the market. There are also multiples of types of attacks targeted at health data, such as attacks to encrypt and access patient data or cases where the attacker takes pictures of the information displayed from available interfaces (monitors, tablets, etc.) by his own device (most often mobile phone). In the Czech Republic, no published statistics are available on the leakage of sensitive data in health care, and only after the effectiveness of the regulation was required to report them.
51. The Authority also referred to the definition of health data contained in Article 4 (15) of the Regulation and detailed in its preamble, and to the fact that the Regulation classifies health data among the specific categories of personal data for which Article 9 of the Regulation lays down stricter rules than those laid down in Article 6 of the Regulation for the processing of normal personal data. The processing of specific categories of personal data shall be prohibited unless a derogation is provided for in Article 9 (2) of the Regulation. However, exceptions to this prohibition are narrower and more specific than the grounds for processing the normal categories of personal data referred to in Article 6 of the Regulation. Therefore, the administrator must carefully consider whether one of the 10 reasons given here testifies. In the case of public interest, the adjective "significant public interest 'is used, which clearly increases the requirements laid down for processing.
52. According to the Office, the contested legislation of the NZIS creates a generous and fully open framework for the operation of health registers, which may arise according to current needs. The Health Services Act foresees for the purposes of health registers the collection of perhaps all existing personal data provided by the Ministry of the Interior, the Police of the Czech Republic and the Czech Statistical Office from basic registers and other information systems of public administration.
53. In the context of the argument contained in the proposal, it is important, according to the Office, that the rights of the data subject in relation to the entire NZIS cannot be based on the consent of the data subject, although the consent institute for the processing of personal data is the primary fulfilment of the right to information self-determination. The performance of tasks in the protection of public health and the provision of medical care requires a solid and reliable legal basis that allows equal access to all those to whom care and certain services are to be provided, while respecting the current situation and the future needs of each individual and of care providers. However, the consent of the data subject shall not comply with those requirements by its appeal capacity. In such a situation, all available guarantees must therefore be available.
54. The protection of personal data and the rights of data subjects is not at all addressed in the title of Part Three of the Sixth Health Services Act, or has been omitted in the context of health registers. In this respect, the legislation is unbalanced and unilateral and follows, as stated in the proposal, on previous legislation under the People's Health Care Act. Therefore, neither the principles and rules on the protection of personal data have been sufficiently reflected in the legislation of the health registers, nor the NRZP, for which the change occurred only in the fact that the register was changed to non-public. The finding sp. zn. For the purpose of health registers, as the Health Services Act lists them in Sections 70 (1) and 73, it is clear that only anonymous data would be sufficient to fulfil certain purposes. In other words, that head of law requires sensitive personal data to be transferred to health registers, which are kept for a long time without, for example, explaining in the explanatory statement why and to what extent each of the purposes pursued requires the processing of sensitive personal data and why it is not sufficient to work with, for example, aggregated data. The objectives to be fulfilled by health registers could be achieved by transmitting already anonymised data to health care institutions. Such data could not be the subject of a leak.
55. Finally, the Authority notes that, since the adoption of the sp. zn. Pl. ÚS 1 / 12 of the Privacy Standard as compared to the Directive, the protection of personal data and privacy requirements, which constitute fundamental rights protected by constitutional order, have also increased. It is then true that the contested legislation will not stand up all the more if it is not a sufficient legal basis for the maintenance of health registers and there are insufficient guarantees to protect those rights of the persons concerned.
Expression of the Institute of Health Information and Statistics of the Czech Republic
56. First of all, the Institute states that the complete abolition of the regulations contained in Sections 70 to 78 of the Health Services Act would lead to the complete liquidation of the NZIS and thus to the liquidation of a single centrally controlled collection of data in the health care sector. Most functional and highly needed health registers have existed for decades, many of which have been modified or newly initiated by the amendment to the Health Services Act 2016. These are always registries that lead as important information systems by most European Union countries (e.g. oncological, cardiothoracic) and whose data are compared between Member States. The claim that modern medical care monitoring is a component of a totalitarian regime cannot stand in the light of objective international comparisons. On the contrary, modern medicine and its evaluation must be based on very robust national data. The methodology of all registries in the NZIS is based on the international recommendations issued on an ongoing basis.
57. According to the Institute, the way registers were created was properly discussed by professional companies and professional chambers and was subject to a wide and open comment procedure. The result was the submission of an amendment to the Health Services Act (published as Act No. 147 / 2016 Coll.) The legislative council of the government without conflict, with the utmost respect for the protection of personal data and the rules of cyber security. The amendment pursues a single fundamental objective: to increase the information value of the NZIS by using existing data in Czech health care, exclusively generated by public health insurance services. The use of these data does not in any way restrict the business or economic activity of any entity.
58. The purpose of NZIS is not to monitor patients as all analyses take place over fully anonymised and aggregated data. Its purpose is to monitor the parameters of care - this must, however, be attributed to a patient who is not identified in any way. Given that the data are processed without its consent, priority is given to value considerations of public interest, thereby limiting the individual's right to information self-determination in order to fulfil its rights under Article 31 of the Charter. The protection of fundamental rights shall be ensured in full compliance with the legislation in force. During the entire existence of the NZIS, there was no single incident of abuse in the data collected.
59. The appellant of the reference found by the Constitutional Court sp. zn. Pl. ÚS 1 / 12 The Institute states that it concerned NRZP, which was conceived as public. Therefore, neither the patient registers nor the NZIS, which are conducted under completely different conditions, are affected. The appeal of the Constitutional Court was thus heard in order to set more strictly the purpose of the registries forming the NZIS and the circle of authorised persons having access to the register. By Act No. 147 / 2016 Coll., the new NRZP was established as a completely non-public, reference, agendas system, built on the principles of "eGovernment ', and the law explicitly and clearly laid down the rights and conditions of access to the register, respectively the heading of authorised staff (Sections 70 and 73). NRZP is the basic management register of any functional system" eHealth. "If the State had not built such a register, these databases would have been created in a partial way at various offices and institutions, which would have significantly increased the risk of data work. NRZP cannot be replaced by any other system or register of professional chambers and it does not concern data surplus to the sub-systems of different institutions.
60. The claim that aggregated data in so-called health service providers' reports (state statistical service) are sufficient is incorrect. These reports allow only a rough epidemiological view of the system and, moreover, far from all major diseases and health problems. These data therefore do not allow an exact evaluation of the quality and effectiveness of the use of healthcare products.
61. Act No. 147 / 2016 Coll. did not introduce the "mass" of new registers for their interconnection. Instead, there is the innovation of the National Register of Paid Health Services, which only uses data already collected without the consent of the patient by health insurance companies. The appellant's claim that other legal instruments and institutions are intended to collect patient data in order to manage the quality of hospitals, the Institute rejects the fact that the basic principle of health care quality assessment is that it must be a transparent system based on objective (reference) data. It is the NZIS that represents the system, because the quality of care cannot be assessed by the body itself. That amendment to the Health Services Act was prepared to fulfil the Ministry's supervisory obligation over health insurance companies and thus to facilitate the entire public health service system. The reason for the existence of this register is therefore to use existing and regularly collected care data paid from public health insurance for comprehensive analyses of the health status of the population, the morbidity and its risks, the availability of care and its quality and for analyses of weaknesses in the network of health service providers.
62. As regards the provisions of § 71 (3) and (4) of the Health Services Act, the Institute states that these are sub-records of specific registers, not of area data collection, which is also evident from the officially published guidelines on NZIS registries. It is not a comprehensive monitoring of all parameters in all registers, which would certainly be problematic. As regards § 71 (10) ("the data necessary for the performance of the task '), the Institute then states that it is a legally specified range of data, namely data from registers according to § 71 (1) (a) and (d) and from the Czech Statistical Office.
63. As regards the lack of the possibility for the data subject to request the deletion of data from the Institute Registry, it states that this is a requirement which would make it impossible to evaluate the quality of care precisely and would ultimately harm patients. In this context, it asks what it would make sense to monitor, for example, the size and quality of the care of the mother and newborn child if the data subjects accidentally had the database greased, and it corresponds to the result being a chaotic and unrepresentative source of data. Similarly, the National Hospital Registry is the only source of data to assess the development, burden, availability and quality of bed care. If it had been annulled, partial hospital information systems in hundreds of hospitals could not replace it, and hospitals would lose the opportunity to compare their results to total.
64. On Article 78 of the Health Services Act, the Institute points out that the number of authorised workers is clearly set out in Section 73 (2) of the same Act. The Implementing Decree then sets out only the particulars of the application for access to and revocation of personal data and other data held in medical registers.
65. Paragraph 41a (1) of the Public Health Insurance Act states that this collection of data is voluntary, is contracted and is not part of the NZIS. The reference network of providers (hospitals) is published in the Ministry of Health Bulletin No 8 / 2016 and will be updated annually. The rules are proposed in the form of a methodology and all methodological documents within the DRG are publicly available and subject to opposition and corrections. The subject of the legal regulation is not the definition of a detailed methodology, merely the establishment of an obligation for the Institute to transmit "up-to-date data and methodologies' to the Ministry within the defined deadlines. The Institute only carries out analytical evaluations and elaborates a methodology for evaluating the hospitalisation case, but its application to practice is not within its scope (the definition of existing processes is under the Ministry's gestion). The consistency of steps in legal aspects related to changes / optimisation of the DRG system is processed. In addition, the Institute points out the Communication of the Czech Statistical Office No. 313 / 2016 Coll., on the updating of the Classification of hospitalized patients (IR- DRG) [the latest communication of the Czech Statistical Office on the updating of the Classification of hospitalized patients (IR- DRG) was published with effect from 1 January 2019 under No. 218 / 2018 Coll. - Note of the Constitutional Court].
66. Finally, the Institute recommends rejecting the proposal.
67. By calling on the Constitutional Court of 6 October 2020, the Institute was further asked to comment or answer the following questions. It was first called upon by the Constitutional Court to state for each specific purpose of the NZIS (Sections 70 (1) and 73 (1) of the Health Services Act) the specific scope of the individual data, the collection of which is necessary to fulfil them, as well as whether patient identification is necessary to fulfil them. In particular, he had to comment on the data relating to the limitation of incapacity, family status, the date of his or her change and the place of marriage or registered partnership, the name, surname and surname of the spouse or registered partner (see Section 71 (3) (m) or 4 (n) of the Law on Health Services), the name, surname and nationality of the child, the spouse, the adopter, the administrative expulsion, the mother's and father's birth numbers and the date of acquisition of legal power of adoption or the decision to abolish the adoption. Secondly, the Institute was to answer the extent to which the technical security of data storage was modified and how it could be monitored or recorded which persons, when and why they were actually looking into NZIS. Thirdly, it should have expressed its views on whether the contested legislation contained guarantees against unauthorised access to and possible misuse of data or remedies.
68. The Institute referred to its earlier observations and reiterated that the contested legislation was compatible with the constitutional order. For the purpose of NZIS (§ 70 (1) and § 73 (1) of the Health Services Act), it stated that "all specific data held in the health registers are intended to comply with the provisions laid down in the provisions cited '. By law-defined personal data, the system" necessarily needs to be able to correctly assign a specific health service provider, a specific remuneration for these services, a specific content of the services provided to a specific result such as occurrence of adverse events, complications, patient survival, etc. "Other than the unanonymous collection of data according to him, the purpose of the law cannot be achieved. Identification of the patient, including as an insured person, is necessary and important for all systems within the NZIS.
69. The Institute further stated that the legal basis for processing personal data in the NZIS is Article 9 (2) (h) to (j) of the Regulation. As the controller of personal data, the Institute has been examined several times by the Data Protection Office, the last inspection being completed on 6 March 2018. In its observations, the Institute summarised the conclusions of the control protocol. In particular, he stressed that he had contracts under Section 6 of the Data Protection Act, which contained safeguards on sufficient technical and organisational security of personal data. In addition, the Institute took measures to prevent unauthorised or accidental access to or misuse of personal data. Similarly, the Institute has prepared and documented the technical and organisational measures taken to ensure the protection of personal data in accordance with Section 13 (2) of the Data Protection Act. In the field of automated processing of personal data, the Institute ensures that systems for automated processing of personal data are only used by authorised persons [Paragraph 13 (4) (a) of the Privacy Act]. The Institute shall also, in accordance with Article 13 (4) (c) of the Personal Data Protection Act, make electronic records to determine and verify when, by whom and for what reason personal data have been recorded or otherwise processed. All access to personal data is recorded.
70. The operational safety of the NZIS itself is ensured by a system of measures based on ISO 27001 and Decree No. 82 / 2018 Coll., on security measures, cyber security incidents, reactive measures, procedural requirements in the field of cyber security and data destruction (Cyber Security Order), as well as "a set of technical tools for monitoring and evaluation of operations, log management, processed Business Continuity and other tools and measures." The Institute also refers to the operational methodologies of the NZIS, which according to it fully comply with the legislation as well as ISO / IEC 27001: 2013 and ISO 10001: 2007.
Observations of the Czech Medical Chamber
71. At the outset, the CLK stated that it did not feel legally competent to examine the issue which is the subject of the proceedings before the Constitutional Court as regards the proportionality test between the protection of personal data on the one hand and the public interest in the information on the state of the population on the other hand.
72. However, the Member considers that the information provided under the contested provisions of the Health Services Act is generally necessary for the State to decide on measures in the context of health care for the population. The information in question may be a good basis for knowledge of demographic conditions in terms of the occurrence of individual serious diseases and the provision of health services in individual regions and from this point of view, the CLK considers that there is a public interest in providing them.
73. The full abolition of all the contested provisions of the Health Services Act does not consider the CLK to be appropriate, desirable or necessary for the protection of citizens' personal data. Even if the Constitutional Court had given the legislator a certain period of time and postponed the enforceability of the finding for a reasonable period of time for the adoption of new legislation, even in such a case, especially in the last year before the parliamentary elections, there could have been a situation where the legislator would no longer have been able to adopt the new legislation and it would have been that those provisions of the law, which undoubtedly have their purpose in terms of managing the care of the population, would not be replaced, and all the information system of Czech health would have died for some time.
74. As regards the register of individual diseases, hospitalisation, etc., the CLK considers that there is a much more detailed overview of the individual citizens - insured persons and their state of health - of the health insurance companies whose employees have an obligation of confidentiality, but are not official persons or civil servants. The Member considers that, if they have the relevant information to a much greater extent, the employees (including private) of health insurance companies cannot be a threat to the protection of personal data, if they are only required to designate a civil servant obliged to remain silent under criminal sanctions with sensitive personal data communicated under the NZIS.
75. In the opinion of ČLK, the national register of providers is also needed, as anyone entitled to provide health services should be registered by the State, similar to those registered in the trade register by traders.
76. The question under the CLK is whether the register of all health professionals, including all personal data to be kept in the register under the law, must be maintained, in particular in a situation where the registers of doctors, dental practitioners and pharmacists are kept by the professional chamber established by the law and are therefore partially duplicate registers. The extent of the data kept on individual health professionals in this register is also considered. However, the Member does not claim that the existence of NRZP is contrary to constitutional order.
77. In conclusion, the CLK expressed the belief that, in addition to the register of health professionals, all other registers could contribute to better health protection and better decision-making on the adoption of laws and other measures in the health sector, because without this information, decision-making on measures to improve the health status of the population would be much more difficult. The public interest in the existence of these registers undoubtedly exists.
General Health Insurance Company of the Czech Republic
78. In the statement sent by its Director, the NZIS stated that it was also intended to do so (which is highlighted by the new amendment to the National Register of Paid Health Services) in order to collect non-anonymized data on persons receiving health services covered by public health insurance and on such health services on a whole scale. According to the GPA, it is necessary to respect the constitutional requirement that the mere legal framework for the processing of personal data is not sufficient, but that the processing of such data must be necessary, justified, effective, logical and defensible for the objectives pursued. To this end, the SAO notes that the NZIS and the information which it makes available to it is clearly beneficial to the quality of healthcare. They allow better evaluation of the availability and safety of health care, including monitoring its quality. Based on these data, it will be possible to introduce a reliable system of control and optimisation of medical care for various social and demographic groups, and to optimise the network of healthcare providers. The NZIS thus constitutes a transparent instrument for determining the public interest as defined in § 17 (2) of Act No 48 / 1997 Coll. These aspects of the NZIS are so important and the public interest is so strong that the Constitutional Court should confirm compliance of the contested provisions with the constitutional order.
79. According to the SAA, the new NZIS regulation is rational and justified in relation to the objectives pursued, which are defined in general but nevertheless unequivocally in the Health Services Act. It cannot therefore agree with the view that the purpose of the NZIS and the registers themselves is vague or all-inclusive. In addition to the purpose of the NZIS, that law also describes in detail who and when the data are anonymised or who has access to data not intended for publication. There is no other way of dealing with them than the way in which they are treated.
80. The repeal of the contested scheme would have irreparable consequences, according to the MIP. In fact, when the NZIS was abolished, health statistics on the health status of the population would be lost, and so would the national statistical services. These data have been collected for many years and are successfully used not only in the health system in the Czech Republic but also in comparison with other EU and world countries. Information from registers is used for long-term monitoring and analysis of the occurrence of monitored diseases and treatment methods in the Czech Republic, with the data found being processed in epidemiological studies and serving medical research. According to the information provided by the NZIS, it is also registered as the so-called agenda resort registry in relation to the basic registers under Act No. 111 / 2009 Coll., on basic registers, as amended, and as a result of its abolition, the function of these registers would be compromised as one of the tools to reduce administrative burden and de-burden to the public administration. The fulfilment of international obligations towards international organisations would also be hampered.
81. The new NZIS regulation was mainly due to the need to fulfil the public interest and because the State found that the present regulation was not sufficient. The most fundamental change is the establishment of a National Register of Reportable Health Services, which processes data previously collected by health insurance companies without the consent of the insured person. This register is also designed as an instrument of the Ministry to fulfil its supervisory obligation. In addition, the Ministry has an obligation to define, under the Public Health Insurance Act, the public interest in the stability of the public health insurance system, which cannot be achieved objectively without this instrument, since the previous legal situation was not satisfactory from the point of view of health insurance companies, let alone transparent. The Ministry will thus have an undistorted view of the health care assessment through the data in this register.
82. To the appellant's assertion that some data, such as the birth number, are superfluous, the PPA states that the NZIS does not foresee the use of this data beyond what is strictly necessary. The birth number here is not intended to identify an individual insured person - a patient, but to "bind" the data on the care provided, as well as the sociomographic data relating to it. The birth number is the only indication that this link forms in place and time - so it is the only constant that allows such "binding." In addition, existing registries, such as the cancer registry, have been based since the 2nd half of the 1970s. If NZIS were to resign from the use of the birth number, it would be necessary to create a new identification code that would allow the information to be reconnected from the records at the place and time. Without such connection and connection to the individual, it is not possible to achieve the stated objective, i.e. to monitor, inter alia, the availability, course and results of the care provided.
83. Paragraph 41a (1) of the Public Health Insurance Act states that they cannot be assessed in isolation. From the point of view of the Constitution and the Providers, it is mainly about fulfilling the contractual relationship, which can be concluded on the basis of § 41a (4) of the same law. In addition, both the decisions of the Constitution and the ministries are reviewed.
84. In conclusion, the GPA states that, although the creation and operation of the NZIS is an intervention in the constitutionally guaranteed right of privacy under Article 10 (3) of the Charter, it is, in its view, admissible. In addition to the legal and legitimate objectives, the company's constitutional interest in the existence of a legitimate collection of personal data is also established. The GPA considers that the contested regulation reflects not only the public interest in the protection of public health but also indirectly protects the right of particular people to health protection.
Expression of the Association of Health Insurance Companies of the Czech Republic
85. The CAP first states that the associated employee insurance companies held a different view on the amendment made by Act No. 147 / 2016 Coll. compared with its promoter (Ministry), in particular where the principles on which the National Register of Paid Health Services is to be established are the principles. The CAP raised doubts as to whether such comprehensive data collection was effective and necessary to meet the objectives of the petitioner. In the CAP's view, the amendment therefore refers to Article 7 or 10 of the Charter, with the right to the integrity and privacy of the person enshrined therein being limited only in cases provided for by law. However, such a law must always measure the purpose for which it limits that right, given its weight. This purpose must necessarily be precisely identified by law.
86. In general, the PMI occupational health insurance companies are not opposed to the collection of health data, which, as a result of the analyses, could be valuable for the correct setting of payment mechanisms, the effectiveness of treatment procedures, etc. However, they are convinced that there is always a need to carefully consider whether such an objective cannot be achieved in another way and whether, by its nature, the relatively broad collection of personal and sensitive data is justified, effective and necessary.
87. The CAP also points out that health insurance companies with effect from 1 September 2015 (see Act No. 200 / 2015 Coll.) may provide sufficient detail to the Ministry of Health and the Ministry of Finance without the need to assign detailed information on all health performance to specific citizens. Both ministries are entitled, pursuant to § 14a of the Act of the Czech National Council No. 280 / 1992 Coll., on departmental, branch, corporate and other health insurance companies, as amended, and § 11 of the Act of the Czech National Council No. 551 / 1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended, to request free of charge information from health insurance companies from the health insurance insurance information system which is necessary for the exercise of their responsibilities in the maintenance and development of the insurance redistribution system or in the monitoring of the economic efficiency of health services. In addition, the Ministry of Health has the right to require the health insurance company to provide the information necessary for the performance of its duties in the creation of payment mechanisms of the public health insurance system or in the monitoring of the local and temporal availability of health services. As a general rule, those provisions are ad hoc provision of economic data without any link to personal data.
88. The above-mentioned opinion of the CAP (see paragraph 85) has been repeatedly discussed with representatives of the Ministry, as a result of which the Ministry has undertaken to take into account the "procedural reservations and warnings' of the CAP in the implementing rules and to establish rules for the adequate protection of personal data against unauthorised treatment or misuse of personal data. In the follow-up negotiations on the setting of rules and principles for the transfer of data to the National Register of Reportable Health Services, in particular in the context of the identification of the insured person, the long-term approach of the CAP has been confirmed that the only right procedure is the transmission of data through AIGO, which will ensure the protection of personal and sensitive data of the concerned entities by anonymising them in the collection process. In the event that the corresponding identifier is not detectable (not identified by insured persons, foreigners), the internal anonymous identifier of the health insurance undertaking concerned will be used, with additional statistical information such as age, sex, locality, etc. At the same time, it was agreed that the administrator of the basic registers would offer another way to identify insured persons, for example without the use of the previously mandatory RUIAN identification (public remote access to the data of the registry of territorial identification, addresses and real estate), in order to reduce the number of unidentified insured persons, and in addition the data processing mechanism on the part of the basic registers for the transformation of agent identifiers will be modified. In addition, representatives of the" eGovernment 'have confirmed the opinion of occupational health insurance companies that the State should manage the reference database of health establishments and health professionals, with only specific information relating to the contractual relationship with the provider being transmitted to that register by health insurance companies.
89. According to the CAP, NZIS needs to be tested repeatedly for compliance with the regulation as a directly applicable EU regulation.
90. In conclusion, the CAP states that occupational health insurance companies support good management and efficient use of health data, particularly in the context of setting rules for the long-term sustainability of public health funding. However, a prerequisite for such good governance and effective "extraction" of health information must be that the principles of the protection of personal and sensitive information on insured persons are maintained in accordance with the constitutional order.
Replication of the appellant
91. The observations were sent to the appellant for a possible reply; it did not take advantage of that possibility.
Expression of the Office of the World Health Organisation in the Czech Republic
92. In addition, the WHO Office was requested to comment on the application for annulment of the contested legal provisions, in particular to inform the purpose for which personal data referred to in Sections 70 (2), 71 (1) to (5), 7 and 9, 74 (1) and (2), 76 (1) and 77a (3) of the Health Services Act are transmitted to the NZIS individually for each of these data. It was further requested to be informed whether the contested legal regulation is related to the obligations of the Czech Republic under international law and whether the WHO requires a certain standard of national regulation in this respect.
93. The office of the WHO sent its observations to the Constitutional Court not in the Czech language (§ 33 (1) of the First Law on the Constitutional Court) but in the English language. It only briefly stated that the WHO does not have any legally binding instructions or requirements from the Member States in the region. However, the WHO advocates finding solutions that comply with ethical requirements and respect for human rights of individuals and patients. This also applies to the field of data collection as well as to other areas related to data management for supervisory purposes or statistical purposes.
94. In view of the language used, the opinion of the WHO Office and its general content, the Constitutional Court did not consider it necessary to send it to the appellant for a possible reply.
Observations of Iuridicum Remedium, p.
95. On 2.6.2020, the Constitutional Court received an unsolicited statement from Iuridicium Remedium, hereinafter referred to as "the Association." It states that the motive for sending it was the performance of the Director of the Institute at the meeting of the Health Committee of the Chamber of Deputies on 15 April 2020. The Association, in conjunction with the reply of the Data Protection Officer, identifies the Institute that "there is already a technical and organisational intention to use individual data from NZIS as a source of information on the health status of specific patients'. In particular, the connection of data on patients with COVID-19 disease to NZIS is to be prepared in order to use sources of information on patients' health status, not to obtain statistical data on the functioning of health, but in individual healthcare. For such a system to work, NZIS data would have to be linked to ISIN without patient consent. It follows from the appeal that" the Constitutional Court will also take into account the risk of managing health registers in relation to possible future expansion or directly changing their purpose, currently in connection with the use of individual data from the National Health Information System... in addressing the impact of the COVID-19 pandemic. "
Speech of Advocate Mgr. Richard Open
96. The Judge-Rapporteur, at the initiative of Judge Kateřina Šimáčková, of 6 October 2020 (see paragraph 99), requested observations in the form of amicus curiae brief Mgr. Richard Open, an attorney specialising in the right to the protection of personal data. In his observations, he stated that, when assessing the compliance of the contested legislation with the requirements of the Regulation, he concluded that the rules on the operation of the NZIS "were" deficient ', in particular, when it came to the requirement of proportionality, whether it was seen as "the optics of intervention in the Charter of Guaranteed Rights, or by more detailed rules which are required by the Regulation'. In particular, the reason is that the NZIS is based on the centralisation of data, as evidenced by Section 72 (2) of the Health Services Act. The inspiration could be the Act No. 111 / 2009 Coll., on Basic Registers, as amended, which provides for higher guarantees than the contested legislation, for example, in that" once a year, data-box bodies have an overview of who accessed data in the Basic Registers and for what purpose. "The contested legislation could then enter an ideal balance even if it was based on the concept of" opt- out. "At the same time, according to him, the contested legislation does not contain the appropriate and specific guarantees or adequate measures to ensure and protect the rights of data subjects to the extent and quality required by the Regulation. Mgr. Opened also on the issue of administrative punishment on the personal data protection section and points out that the Health Services Act contains gaps in this regard, because" if we already find a specific obligation to protect personal data, such an obligation is not part of the facts of the offences, except for exceptions. "In his view, relying on the effectiveness of the regulation itself with its" huge fines "is not realistic, since Article 61 (3) of Act No. 110 / 2019 Coll., on the processing of personal data," creates one significant concession when ordering the supervisory authority to waive punishment. "It therefore concludes that the Health Services Act does not contain the required guarantees, either in conjunction with other legislation.
Expression of Director of the Faculty Hospital in Motola JUDr. Ing. Miloslav Ludvík, MBA
97. The Judge-Rapporteur also requested an additional statement by JUDr. Ing. Miloslav Ludvík, MBA, Director of the State Contribution Organization of the Faculty Hospital in Motola. In particular, it should have been apparent from its observations whether it considered the individual data collected in the NZIS necessary to achieve the specified purposes of processing the data. JUDr. Ing. Miloslav Ludvik points out in his observations that he believes that "a causal link is made between the provision of individual data and the achievement of the defined purpose... although it would not often appear so at first sight."
98. In his observations, JUDr. Ing. Miloslav Ludvík, MBA, communicated to the various data which he saw their need for, or what they contributed to, the purpose of NZIS (Sections 70 (1) and 73 (1) of the Health Services Act). As regards the limitation of incapacity, the latter sees it as "necessary in order to obtain information on the possibility for patients to decide on the state of health and follow-up '. The importance of this data is also seen in the possibility of obtaining information on the limitation of the patient's incapacity in relation to his specific diagnosis. According to him, the indication of the family condition allows to obtain information about the environment from which the patient came, as well as information in relation to the reality of his recovery. The same need is also required for an indication of the date of the change of family status and the place of marriage or registered partnership, the importance of which is also seen in relation to the current epidemiological situation in the site concerned. The indication of the name, surname and birth number of the spouse or registered partner is important not only from a medical point of view (for example, in relation to the occurrence of an infectious disease in the common household) but also from an administrative point of view, as spouses and registered partners are close to whom certain rights also exist in the provision of health services. In connection with the adoption data, JUDr. Ing. Miloslav Ludvík, MBA considers it desirable to" map the history of this process from the point of view of the link with the Health Services Act and the legislation contained therein. "Therefore, contrary to the appellant, the individual data is not assessed as unrelated or unfounded and therefore unnecessary.
Oral proceedings
99. The Constitutional Court, in order to further clarify the case, ordered, pursuant to Article 44 of the Law on the Constitutional Court, the holding of an oral hearing, first to 31 March and 1 April 2020, and after its postponement [with regard to Government Resolution 194 of 12 March 2020 on the declaration of an emergency state (No 69 / 2020 Coll.), the decision of the President of the Constitutional Court of 12 March 2020 No. 21 / 20 limiting public access to the Constitutional Court building and the Government Resolution of 15 March 2020 No 215 on the adoption of emergency measures] to 13 October and 14 October 2020. By decision of the Constitutional Court of 15 September 2020, the oral procedure was annulled "because of the epidemiological situation '. The Constitutional Court therefore requested written observations from the Deputy Minister of Health for Legislation and Law of JUDr. Radek Policara, Director of the Institute of Prof. RNDr. Ladislav Dušek, Ph.D., President of the Czech Medical Chamber MUDr. Milan Kubka, Director of the Faculty Hospital in Motole JUDr. Ing. Miloslav Louis, MBA, and Advocate General Mgr. Richard Open. To these challenges, the Constitutional Court received observations from the Director of the Institute (recap in paragraphs 67 to 70), the Advocate General Mgr. Richard Open (see paragraph 96) and JUDr. Ing. Miloslav Ludvík, MBA (paragraphs 97 to 98).
Proceedings before the Constitutional Court
100. The Constitutional Court notes that it is competent to discuss an application for annulment of the contested legal provisions. The proposal fulfils all the formal requirements laid down by law and has been submitted by the authorised appellant [Paragraph 64 (1) (b) of the Constitutional Court Act].
101. The Constitutional Court has already examined the proposal for the annulment of the Law on Health Services, possibly the annulment of its paragraphs 70 to 78, namely those provisions which are also contested by the present proposal. Paragraph 76 and Article 77 of the Law on Health Services were repealed by Decree No III of the Found. These provisions were then re-inserted into the Act by Act No. 147 / 2016 Coll., amending Act No. 372 / 2011 Coll., on health services and the conditions for their provision (Health Services Act), as amended, (Article I, point 42). In the remainder, the proposal to abolish the whole of the law and its provisions, paragraphs 70 to 78, were rejected (operative part V). The Constitutional Court found that "some of the objections raised were not eligible for a substantive assessment ', while the application for annulment of the legal regulation of the NZIS did not clarify whether" the purpose of all the sub-( and relatively separate) registers which constitute it or only some of them is called into question'. The Constitutional Court also considered it vague "that, contrary to the original legislation, the new way in which the database is to be technically created and the encoding of the data placed therein was not specified and that the scope of the data to be anonymised was not defined '. Even in this case, the proposal did not specify which parts of the NZIS are objecting to and, in addition to referring to certain provisions of the Charter and of the Convention on Human Rights and Biomedicine, it did not" contain any consideration which would show why the facts stated should constitute a contradiction with constitutional order'. Thus, the proposal met the requirements of certainty of the alleged reason for the unconstitutionality of the contested provisions only in the part against NRZP legislation (recitals 292 and 293 to the preamble). At the same time, however, the Constitutional Court stated that "in this proceeding it did not examine the constitutionality of the legislation of the National Health Information System as a whole, but only addressed certain aspects of those provisions relating to the National Register of Health Workers. In addition to the present review, this finding therefore does not constitute an obstacle to the decision-making act in respect of paragraphs 70 to 78 of the Health Services Act, and therefore nothing prevents the interveners (or any other authorised appellant) from filing a new proposal against those provisions, in which they specify the reasons for which they seek their annulment. 'For these reasons, the Constitutional Court considers that the proposal currently under examination is not inadmissible under Paragraph 35 (1) of the Constitutional Court Act, since it does not concern a case already decided by the Constitutional Court.
102. After the opening of the application for annulment of the contested provisions, Article 71 (13) (now Article 12) of the Health Services Act was amended by amending Article 71 (13) (now Article 12) of the Health Services Act by replacing, in its final section, the words "sign by means of a guaranteed electronic signature based on a qualified certificate issued by an accredited certification service provider of a person authorised to act as a provider, unless the application is received by means of a data box 'by the words" sign in a manner with which another legislation links the effects of the handwritten signature 51)', and a footnote under footnote 51 was inserted in the law.
103. In addition, Section 70 (3) of the Health Services Act was supplemented in the course of the proceedings by the Law No 290 / 2017 Coll. by the following sentence being inserted after the first sentence: "The head of the Statistical Institute is the Director, appointed and dismissed by the Government on a proposal from the Minister for Health." Paragraph 77a (3) has also been amended by this Act by introducing the text of its letter (a) (at the date of the application, point (a) was amended as "the insured person's identification number to whom the health service specified in (b) has been provided and paid by the health insurance provider (s) of the social services,"] and added new points (b) and (c), including footnote 54, marked as (d).
104. Finally, during the procedure of Law No 111 / 2019 Coll. amended Sections 70, 71, 72, 73, 74, 75, 76 and 77 of the Health Services Act as follows: In Paragraph 70 (4), points 7 and 8 were added at the end of point (e); in Paragraph 71, paragraphs 7 were deleted (and in that context paragraphs 8 to 15 were renumbered paragraphs 7 to 14, and in the text of Paragraph 71, references to these paragraphs were renumbered); in Article 72 (1) (a), the words "and from the statistical surveys carried out by the Ministry outside the statistical survey programme 'were inserted after the words" statistical surveys', and new points (h) to (j) were inserted after point (g), including footnote (60); in Article 73 (1) (e), the word "age 'was inserted after the word" profession', the words "age 'were added after point (j) and after paragraph (4) new paragraphs (5) to (7) were inserted, including footnote (61) (and, in that context, paragraphs 5 to (9) were renumbered as paragraphs 8 to (12) and the references to the relevant paragraphs were renumbered to the relevant paragraphs); in Paragraph 74 (1) (d), the words" (f) and "and' were deleted and new points (o) and (p) (a) were added to the words" to (i) ', and in point (c) the word "n' was replaced by the word" o) ', in paragraph 3 (a) the introductory sentence was deleted from the words "data on', in point (1) the word" address' was replaced by the word "persons and 'was replaced by the word" persons', and point (1) was replaced by the words "persons', including the words" persons', and the former point (2) was replaced by the words "competence ', and the words" data on the beginning of the words "data on' were added to the words', and at the beginning of the words'; (k) the words', the type of employment relationship and the extent of the weekly working time provided for in the case of a medical profession based on employment 'are added to point (m), the words' entry in the list of members of the chamber 'and' in paragraph 2 (e) the words' (f) to (m) 'and the words' availability and quality control of health services' have been deleted and added to points (i) and (j); in Paragraph 77, a new paragraph 2 was inserted, the previous paragraph 2 was marked as paragraph 3, and at the end of paragraph 3 the sentence" The Statistical Institute shall transmit such information to the person referred to in Paragraph 77 (1) who has transmitted the data identified as incorrect to the National Register of Health Workers for verification and correction '.
105. The Act No. 111 / 2019 Coll. also included in Title III of Part Six of the Law on Health Services the new provisions of Sections 71a to 71c, which lay down the obligations of the Ministry of Health, the Ministry of Labour and Social Affairs and the Czech Social Security Administration to provide the Institute with data from the records of (treating) doctors, dentists and pharmaceuticals (§ 71a), as well as the formalities for the application pursuant to § 71a (1) or (2) (§ 71b) and the request of the health service provider to the Institute for the provision of data for the verification of patient's identity (§ 71c).
106. Paragraph 41a (1) of Act No. 48 / 1997 Coll. was amended by Act No. 282 / 2018 Coll. by removing the words "and statistics of the Czech Republic (hereinafter referred to as the Institute of Health Information)." This amendment transferred the legislative shortcut for the Institute to § 39v (4) of Act No. 48 / 1997 Coll.
107. None of the amendments to the contested legal provisions that took place during the proceedings mentioned in the amendments to the Act on Health Services and Act No. 48 / 1997 Coll., does not constitute a ground for the termination of the procedure under Paragraph 66 (1) of the Law on the Constitutional Court. These changes do not constitute a fundamental change in the contested legislation by their meaning and scope. The one that remains in its content remains the one against which the author's argument is directed.
108. Therefore, the procedural assumptions of the proceeding are as follows, with the exception set out below.
109. However, the Constitutional Court failed to see that the appellant in full power granted to the lawyer for the application to the Constitutional Court and for its representation in the proceedings concerning it, as well as on the signature document, defined the subject matter of the proceedings before the Constitutional Court in such a way that "the application for the annulment of certain provisions of Act No. 372 / 2011 Coll., on the health services and conditions of their provision (Law No 48 / 1997 Coll. on the proposal of a group of senators" against the provisions of Law No. 372 / 2011 Coll., on health services and the conditions of their provision '; the (mandate) of the application for the annulment of Article 41a (1) of Law No. 48 / 1997 Coll.
110. To the appeal of the Judge-Rapporteur addressed to the appellant to the lawyer in order to clarify this discrepancy between the proposal and the full authority or signature, the lawyer was informed that the original intention of the appellant and his processor was to challenge only the selected provisions of the Health Services Act. It was only during the actual processing of the submission that the reasons for the annulment also affected Article 41a (1) of Act No. 48 / 1997 Coll. In agreement with the appellant and on her instructions, the lawyer therefore extended the petition to this provision, but 'unfortunately, we have neglected to reflect this regulation into the text of the mandate'. At the same time, the lawyer argues that it is not necessary to reject this part of the proposal for this formal deficiency, pointing, on the one hand, to the legal sentence of the Constitutional Court's finding of 31 October 2001 sp. zn. It also states that it prepared the proposal in conjunction with the appellant and forwarded the final text to it for its definitive approval, which it did. It then concludes that, if not formally, the appellant has in fact entrusted him with the full scope of the petition and asks that, when assessing the conditions of proper authorisation, account be taken of the fact that, in the meantime, as a result of the elections to the Senate, the appellant has partially disintegrated, which makes it no longer possible to amend the text of the power of attorney.
111. On that basis, the Constitutional Court notes that the lawyer - in the present situation - has not, in any way, demonstrated his claim on his agreement with the appellant and on his instruction to extend the petition on the provision of § 41a (1) of Law No 48 / 1997 Coll. nor his claim on the final approval of the appellant. Therefore, it cannot be ruled out without any doubt that the lawyer - even as a processor of the proposal led by an interest in its highest possible quality, that is to say, its completeness in terms of the relevant provisions, which should or might be affected by the alleged reason for the deregulation - did not go beyond the will of the appellant and the authorisation granted to it. It is not primarily a lawyer who, in the proceedings for the annulment of the law or its individual provisions, defines a petition which the Constitutional Court is bound by in the course of the review of the contested legislation, but is the active author herself - by the number of a qualified group of Members or a group of Senators [§ 64 (1) (b) of the Law on the Constitutional Court] - who specifically defines which law (its individual provisions) is to be subject to review before the Constitutional Court, which is confirmed by the members of that group by their signature of the Constitutional Court Act (§ 64 (5), as amended by Law No 320 / 2002 Coll.). If, in the present case, the proposal itself was not signed, but the will to bring it forward was expressed in the form of a signature document annexed to the application and the granting of the power of attorney, the petition being made binding in the signature document and in full power, as stated in paragraph 107 above, it is not left in the section proposing the annulment of Paragraph 41a (1) of Law No 48 / 1997 Coll. to reject the proposal under Paragraph 43 (1) (c) of the Law on the Constitutional Court, as amended by Act No 77 / 1998 Coll., as a proposal made by someone manifestly unlawful.
Assessment of the competence and the way in which the contested legal provisions are adopted
112. According to Article 68 (2) of the Law on the Constitutional Court, as amended by Act No. 48 / 2002 Coll., the assessment of the constitutionality of the law with a constitutional order consists of answering three questions: 1. whether it was adopted and issued within the limits of the Constitution, 2. whether it was adopted in a constitutionally prescribed manner and 3. whether its content complies with constitutional laws.
113. The contested provisions of Sections 70, 71, 72, 73, 74, 75 and 78 of the Health Services Act entered into force on 1 April 2012, when the Act as a whole became effective (see Section 129 of the Law). These provisions were amended by Act No. 303 / 2013 Coll., No. 147 / 2016 Coll., No. 192 / 2016 Coll., No. 298 / 2016 Coll., No. 290 / 2017 Coll. though 111 / 2019 Coll.
114. The contested provisions of Sections 76, 77 and 77a were incorporated into the Law on Health Services (in the case of Sections 76 and 77, after their previous annulment by the Decree III of the Constitutional Court, sp. v. Pl. ÚS 1 / 12) by its amendment by Act No. 147 / 2016 Coll. Paragraph 77a was amended by Act No 290 / 2017 Coll.
115. Parliament was competent under Article 15 (1) of the Constitution to adopt the Law on Health Services as well as all the six laws which amended it. The procedure for the adoption of the Law on Health Services was found by the Constitutional Court to be constitutional in accordance with the procedure sp. v. Pl. ÚS 1 / 12 (see paragraphs 187 and 194 to 223 of the preamble). With regard to its above amendments, the Constitutional Court found out the following from the observations of Parliament's chambers and from publicly available documents concerning the legislative process.
116. The bill amending certain laws in the context of the adoption of the recdification of private law (House Press 930) was submitted by the Government to the Chamber of Deputies on 5 March 2013. On 8 August 2013, at the 57th meeting at the third reading, she agreed to the draft law as amended by the approved amendments (Resolution 1746), when 67 of the 128 Members present voted in favour, 43 opposed and 18 abstained. The Senate debated the bill (Senate Document 173) at its 13th meeting on 12 September 2013 and approved it (Resolution 330) when 43 out of 55 senators were voted in favour, 2 opposed and 10 abstained. The law adopted was delivered to the President of the Republic on 17 September 2013 and signed by him on the same day. Its publication took place in the Collection of Laws on 30 September 2013 in the amount of 116 under No 303 / 2013 Coll.; it became effective on 1 January 2014.
117. The draft Act amending Act No. 372 / 2011 Coll., on Health Services and the Conditions for Their Provision (Health Services Act), as amended, (House Press 614) was submitted by the Government to the Chamber of Deputies on 23 September 2015. The Chamber of Deputies of 9 March 2016 at the 42nd session of the third reading gave its assent to the draft law, as approved by the Chamber of Deputies (Resolution No 1102), when 140 of the 179 Members present voted for it, 35 opposed and 4 abstained. On 20 April 2016, the Senate discussed the bill (Senate Document No 234) at its 22nd meeting and approved it (Resolution No 405) when 44 out of 62 senators were voted in favour, 9 opposed and 9 abstained. The law adopted was delivered to the President of the Republic on 26 April 2016 and signed (decision delivered to the Chamber of Deputies on 4 May 2016). His publication took place in the Collection of Laws on 17 May 2016 in an amount of 58 under No. 147 / 2016 Coll.; it became effective on 1 July 2016.
118. The draft law amending Act No. 111 / 2009 Coll., on Basic Registers, as amended, and some other laws (House Press 655) was submitted by the Government to the Chamber of Deputies on 11 November 2015. On 13 April 2016, at the 44th meeting at the third reading, the bill was approved by the Chamber of Deputies (Resolution No 1161), with 163 of the 168 Members present, no one opposed and 5 abstentions. On 25 May 2016, the Senate discussed the bill (Senate Press No. 260) at its 24th meeting and approved it (Resolution No. 430) when 47 of the 59 senators present voted in favour, no one opposed and 12 abstained. The law adopted was delivered to the President of the Republic on 1 June 2016 and signed (decision delivered to the Chamber of Deputies on 7 June 2016). Its publication took place in the Collection of Laws on 17 June 2016 in the amount of 72 under No. 192 / 2016 Coll.; it became effective on 1 January 2017, with the exception of some provisions effective from 1 July 2016.
119. The draft law amending certain laws in connection with the adoption of the law on trust services for electronic transactions, Act No. 106 / 1999 Coll., on free access to information, as amended, and Act No. 121 / 2000 Coll., on copyright law, on copyright rights and on the amendment of certain laws (Copyright Act), as amended, (House Press 764) was submitted by the Government to the Chamber of Deputies on 31 March 2016. The Chamber of Deputies of 29 June 2016 at the 48th meeting of the third reading gave its assent to the draft law, as approved by the Chamber of Deputies (Resolution 1270), when 126 of the 162 Members present voted for it, 16 opposed and 20 abstained. The Senate debated the bill (Senate Press No. 307) at its 27th meeting on 24 August 2016 and approved it (Resolution No 512) when 37 of the 48 senators present voted in favour, no one opposed and 11 abstained. The law adopted was delivered to the President of the Republic on 31.8.2016 and signed on (decision delivered to the Chamber of Deputies on 6.9.2016). Its publication took place in the Collection of Laws on 19. 9. 2016 in the amount of 115 under No. 298 / 2016 Coll.; it became effective with the exception of listed articles effective from 1. 1. 2017.
120. The bill amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended, (House Press 1017) was submitted by the Government to the Chamber of Deputies on 2 February 2017. On 30 June 2017, at the 59th meeting at the third reading, the bill agreed to the bill in its approved text (Resolution 1738), when 124 of the 141 Members present voted for it, no one opposed and 17 abstained. The Senate debated the bill (Senate Document No 167) at its 9th meeting on 16 August 2017 and approved it (Resolution No 250) when 39 of the 69 senators present voted in favour, 6 opposed and 24 abstained. The law adopted was delivered to the President of the Republic on 23 August 2017 and signed on 4 September 2017. Its publication took place in the Collection of Laws on 15 September 2017 in the amount of 102 under No 290 / 2017 Coll.; it became effective on 1 January 2018, with the exception of the listed provisions effective on the date of its publication or on 1 November 2017.
121. The draft law amending certain laws concerning the adoption of the Personal Data Processing Act (House Press 139) was submitted by the Government to the Chamber of Deputies on 28 March 2018. The Chamber of Deputies of 5 December 2018 at the 24th meeting at third reading gave its assent to the draft law in its approved text (Resolution 409), when 142 of the 184 Members present voted for it, 2 opposed and 40 abstained. The Senate discussed the bill (Senate Document 26) at its 5th meeting on 30 January 2019 and returned it to the Chamber of Deputies with amendments (Resolution 86). At its 27th meeting, the bill was approved by the Senate (Resolution 562), with 147 out of 186 Members voting in favour, 10 opposed and 29 abstentions. The law adopted was delivered to the President of the Republic on 2 April 2019 and signed on 10 April 2019. It was published in the Collection of Laws on 24 April 2019 in the amount of 47 under No. 111 / 2019 Coll.; it became effective on the day of its publication.
122. Paragraph 41a was inserted into Act No. 48 / 1997 Coll. with effect from 1 September 2015 by Act No. 200 / 2015 Coll., amending Act No. 48 / 1997 Coll., on Public Health Insurance, and amending and supplementing certain related laws, as amended, Act No. 551 / 1991 Coll., on General Health Insurance Company of the Czech Republic, as amended, Act No. 280 / 1992 Coll., on Department, Company, and other health insurance companies, as amended, and Act No. 592 / 1992 Coll., on Insurance against Public Health Insurance, as amended.
123. The draft law amending Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended, Act No. 551 / 1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended, Act No. 280 / 1992 Coll., on Department, Business, and Other Health Insurance Companies, as amended, (House Press 386) was submitted by the Government to the Chamber of Deputies on 7 January 2015. On 19 June 2015, at the 29th meeting of the third reading, the bill agreed to the bill in its approved text (Resolution No 793), when 147 of the 164 Members present voted for it, one of the Members opposed and 16 abstained. The Senate debated the bill (Senate Press No. 101) at its 10th meeting on 23 July 2015 and approved it (Resolution No. 189) when 55 of the 64 senators present voted in favour, 4 opposed and 5 abstained. The law adopted was delivered to the President of the Republic on 30 July 2015 and signed (decision delivered to the Chamber of Deputies on 4 August 2015). His publication took place in the Collection of Laws on 17. 8. 2015 in the amount of 82 under No. 200 / 2015 Coll.
124. Paragraph 41a (1) was then amended with effect from 1 January 2019 by Act No 282 / 2018 Coll. The bill amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended, (House Press 199) was submitted by the Government to the Chamber of Deputies on 11 June 2018. The Chamber of Deputies of 3 October 2018 at the 19th meeting at third reading gave its assent to the draft law, as approved by the Chamber of Deputies (Resolution 352), when 168 of the 169 Members present voted for it, no one opposed and one abstained. The Senate debated the bill (Senate Press No. 341) at its second meeting on 15 November 2018 and approved it (Resolution No. 36) when 49 of the 54 senators present voted in favour, no one opposed and 5 abstained. The law adopted was delivered to the President of the Republic on 22 November 2018 and signed on 5 December 2018. It was published in the Collection of Laws on 13. 12. 2018 in the amount of 142 under No 282 / 2018 Coll.
125. These findings make it possible to state that, in the legislative process, all eight of those laws have followed the constitutional procedure and have been adopted by the majority necessary to approve the bill in Parliament's chambers. The laws adopted were also delivered to the President of the Republic, who did not exercise his right to return them to Parliament and signed the laws. It can be concluded that laws containing the contested provisions have been adopted in a constitutional manner.
The contested provisions of the Health Services Act
126. The contested provisions of § 70 to 78 of the Health Services Act contain an amendment to the NZIS and their valid wording is as follows:
NATIONAL HEALTH INFORMATION SYSTEM
(1) The National Health Information System is a single national public administration information system designated by:
(a) the processing of data on the health status of the population, on the activities of providers and their economy, on health professionals and other health professionals, and on the reimbursement of public health insurance health services, in order to obtain information on the scope and quality of the health services provided, on health management and health policy-making, including ensuring transparency in the provision and financing of health services, ensuring equal access to health services and the evaluation of health service quality and safety indicators;
(b) the keeping of national health registers and the processing of data kept therein;
(c) the management of the National Register of Providers, the National Register of Health Workers and the National Register of Paid Health Services and the processing of data held therein;
(d) to carry out and process sample surveys on the health status of the population, on health determinants, on the need for and consumption of health services and on their satisfaction and on the expenditure on health services;
(e) for the needs of science and research in the field of health; and
(f) for the processing of the data referred to in (a) and (d) as well as in the registers referred to in (b) and (c) for statistical purposes, and for the provision of data and statistical information to the extent specified by this or other legislation, including the provision of information to international institutions.
(2) For the processing of personal data in the National Health Information System referred to in points (b) and (c) of paragraph 1, data shall be transmitted without the consent of the data subject (33) unless otherwise specified below, where the data subject is:
(a) patients,
1. the information needed to identify the insured person, the number of the insured person, if assigned, or the birth number, if this number is not the insured person's number, or the date of birth, if the birth number is not assigned, the name of the municipality and, where appropriate, the name of the town or city district, the address of the place of permanent residence and, if applicable, the address of the stranger, the address of the place of residence and citizenship,
2. data relating to his medical condition in relation to the disease and its treatment, in particular those relating to socio-demographic and diagnostic, personal, family and occupational history of the patient related to the disease, including an assessment of his current health status, data on the health services provided to the patient, data on the pursuit of the profession or employment and, where appropriate, on the performance of the service needed to assess the patient's health,
3. identification data of the provider who provided the health services, including separation and workplace;
4. identification details of the last employer in whom the patient who developed the occupational disease last worked under the conditions under which the occupational disease arises;
(b) the provider, the data referred to in § 74 (1),
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Regulation Information
| Citation | The Constitutional Court found no. 6 / 2021 Coll., on health services, and the rejection of the application for annulment of § 41a paragraph 1 of Act No. 48 / 1997 Coll., on public health insurance |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 12.01.2021 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
Public Contracts 1
Smlouva o poskytnutí užívacích práv ke Službě ASPI - právní informační systém
Město Kyjov
Wolters Kluwer ČR, a.s.
443 000 CZK
03.04.2023
Source:
Hlídač státu
(CC BY 3.0 CZ)
The regulation text is for informational purposes only.
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