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21 AOUT 2008. - Act respecting the institution and organization of the eHealth square (1)

ALBERT II, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
CHAPTER 1^er. - General provisions
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
Art. 2. Under the name "platform eHealth", it is created a public institution with legal personality.
The eHealth platform is a public social security institution within the meaning of the Royal Decree of 3 April 1997 on measures for the accountability of public social security institutions, pursuant to Article 47 of the Law of 26 July 1996 on social security modernization and ensuring the viability of legal pension schemes.
The special rules and conditions according to which the eHealth platform carries out the tasks entrusted to it by law are arrested in the contract of administration which it concludes with the State, in accordance with the royal decree mentioned above of 3 April 1997.
For the purposes of this Article, Ministers shall be considered as Guardianship Ministers within the meaning of Article 1^er, 2°, of the aforementioned Royal Decree of 3 April 1997 and the Management Committee of the eHealth Platform is considered to be the management body within the meaning of the aforementioned Royal Decree of 3 April 1997.
The King determines, by order deliberately in the Council of Ministers, the rules relating to the organization and operation of the eHealth platform, including aspects concerning personnel, to the extent that this is not regulated in the aforementioned Royal Decree of 3 April 1997 or in this Act.
Art. 3. For the purposes of this Act, unless otherwise provided, the following means:
1st Ministers: the Minister or Ministers with Public Health, Social Affairs and State Computerization in his or her powers;
2° care providers: health care professionals referred to in Royal Decree No. 78 of 10 November 1967 concerning the exercise of health care professions;
3° care facilities: the establishments and services referred to in the Hospitals Act, coordinated on 7 August 1987, section 5 of the Act of 27 June 1978 amending the hospital legislation and certain other forms of care dispensation and sections 22, 6°, 34, 12° and 21°, 63 and 65 of the Act respecting compulsory health care and allowances, coordinated on 14 July 1994;
4° patient: the natural person to whom health care is provided, upon request or not;
5° social security institutions: the institutions referred to in Article 1^er and Article 2, paragraph 1^er, 2°, of the Act of January 15, 1990 on the institution and organization of a Social Security Crossroads Bank;
6° insurers: national unions, referred to in section 6 of the Act of 6 August 1990 on mutualities and national mutuality unions, the Auxiliary Disability Insurance Fund and the Health Care Fund of the SNCB-Holding;
7° Law on the Carrefour Bank of Social Security: the Act of 15 January 1990 on the institution and organization of a Social Security Bank;
8° ICT: information and communication technologies;
9° personal health data: any personal data that may be deducted from information on the prior, current or future state of the physical or mental health of the identified or identifiable natural person, with the exception of purely administrative or accounting data relating to medical treatment or care.
CHAPTER 2. - Objective of the eHealth platform
Art. 4. The eHealth platform aims to optimize the quality and continuity of health care services and the safety of the patient, to promote the simplification of administrative formalities for all health care actors and to support health policy, through services and mutual electronic information exchanges between all health care actors, organized with the necessary guarantees in terms of the security of information and privacy.
CHAPTER 3. - eHealth platform missions
Art. 5. The eHealth platform is responsible for the following missions to implement its objective:
1° develop a vision and strategy for the provision of services and an exchange of electronic information in effective, effective and duly secured health care, while respecting the protection of privacy and in close consultation with the various public and private health-care actors;
2° to determine functional and technical ICT standards, standards and specifications as well as a basic architecture useful for the implementation of ICTs in support of this vision and strategy;
3° verify whether the electronic patient records management software meets functional and technical ICT standards, standards and specifications, and record these software;
4° to design, manage, develop and make available to health care actors, in standard form, basic services that can help actors, such as:
a) a collaborative platform for the electronic exchange of secure data, including a system for the organization and logging of trade
electronic data, and electronic data access system;
(b) the basic services that are useful in support of this electronic data exchange, such as a data encryption system between the sender and the recipient, an access management system and users, a secure electronic mailbox for each health care actor, an electronic data system, an information encoding and anonymization system, a directory of patient references indicating, with the agreement of the patients concerned, to which data are stored the implementation of the reference directory can only be made after the Health section of the Social Security and Health Sector Committee;
5° agree on a division of tasks with respect to the collection, validation, recording and provision of data exchanged through the collaboration platform and the quality standards to which these data are to be met, and to monitor compliance with these quality standards;
6° to promote and coordinate the implementation of programmes and projects to implement the vision and strategy, which concern several (types of) health care actors and which use the collaborative platform for the exchange of secure electronic data, referred to in 4°, (a), or the basic services referred to in 4°, (b), and coordinate regulatory adaptations for the execution of these programmes and projects;
7° to manage and coordinate the organizational, functional and technical ICT aspects of this data exchange in the context of electronic patient records and electronic medical requirements;
8° as an intermediary body, as defined under the Act of 8 December 1992 on the protection of privacy with respect to personal data processing, collect, aggregate, code or anonymize and make available relevant data to the knowledge, design, management and delivery of health care; the eHealth platform will only be able to maintain the personal data processed in the context of this mission for the duration of their codification or anonymization; the eHealth platform may, however, retain the link between the actual identification number of a data subject and the coded identification number assigned to it, if the recipient of the personal data coded makes the request in a reasoned manner, with the authorization of the health section of the Social Security and Health Sector Committee; the eHealth platform may only carry out this mission at the request of a legislative chamber, a social security institution, the foundation referred to in section 45quinquies of Royal Decree No. 78 of November 10, 1967 relating to the exercise of health care professions, the Intermutualist Agency, the Federal Centre for Health Care Expertise, the non-profit association referred to in section 37, the King may, by order deliberately in the Council of Ministers and after the advice of the Commission on the Protection of Privacy and the Management Committee, expand the list of instances that may appeal to the eHealth platform as an intermediary organization;
9° promote respect for vision, strategy, standards, functional and technical specifications, basic architecture, as well as the use of the electronic collaboration platform for the exchange of secure electronic data and basic services and the realization of projects by a maximum of health care actors;
10° organize collaboration with other public bodies, all levels of power, responsible for coordinating the delivery of electronic services.
CHAPTER 4. - Rights and obligations of the eHealth platform
Art. 6. This Act does not affect the Protection of Privacy Act of 8 December 1992 in respect of personal data processing, the Patient Rights Act of 22 August 2002 and the legal and regulatory provisions relating to the exercise of the art of healing.
Art. 7. For the execution of its missions, the eHealth platform has:
1° access to data recorded in the National Register;
2° the right to use the National Register ID number.
Art. 8. When communicating personal data not coded to or by the eHealth platform, only the identification numbers referred to in section 8 of the Carrefour Bank of Social Security Act are used.
Art. 9. § 1^er. The eHealth platform is a member of its staff and, following advice from the Health Section of the Sectoral Committee on Social Security and Health, an Information Security Advisor.
§ 2. With a view to the security of data processed or exchanged by the eHealth platform and for the protection of the privacy of persons to whom these data relate, the eHealth Information Security Advisor is responsible for:
1° to provide qualified advice to the person responsible for Daily Management;
2° to carry out other missions entrusted to it by the person responsible for day management.
§ 3. The King may, after the advice of the Privacy Commission, set out the rules that the Information Security Advisor of the eHealth Platform performs his or her mission as well as his or her specific skills and rules relating to his or her independence and responsibility.
Art. 10. The Management Committee referred to in Article 15 shall, among the staff of the eHealth platform and after the Health Section of the Sectoral Committee on Social Security and Health, be a physician under the supervision and responsibility of which the processing of personal health data is carried out by the eHealth platform.
The King, after the advice of the Commission on the Protection of Privacy, sets out the rules that the doctor performs his or her mission as well as his or her specific competences and rules relating to his or her independence and responsibility.
Art. 11. Any communication of personal data by or on the eHealth platform requires an authorization in principle of the health section of the Sectoral Committee on Social Security and Health, referred to in section 37 of the Carrefour Bank of Social Security Act, except in the following cases:
1° where, in accordance with a legal or regulatory provision, the Social Security Section of the Sectoral Committee for Social Security and Health or another Sectoral Committee established within the Commission for the Protection of Privacy is competent to grant authorization for communication;
2° where the communication is authorized or exempted from a policy authorization in accordance with a legal or regulatory provision;
3° where the King has exempted the communication of an authorization of principle, by order deliberately in the Council of Ministers, after the advice of the Commission on the Protection of Privacy.
To the extent that a legal or regulatory provision referred to in paragraph 1^er, 1° or 2°, sees the day after the coming into force of this Act, it is the subject of a notice of the Privacy Commission before its entry into force.
Before granting its authorization, the relevant sectoral committee shall verify whether the communication is in accordance with this Act, its enforcement orders and the privacy regulations; In particular, it will pay attention to the possible encryption of the personal data in question. Authorizations shall be granted on time, conditions, and terms determined by the King.
A policy authorization of a sectoral committee established within the Privacy Commission is not required, however, for the communication of personal data coded, as defined under the Act of 8 December 1992 on the protection of privacy with respect to the treatment of personal data, that the eHealth platform carries out, in accordance with Article 5, 8°, in order to conduct statistical studies
A personal data communication for which, pursuant to this section, an authorization in principle of the health section of the Sectoral Committee on Social Security and Health is required, can be carried out only after the granting of such authorization in principle and with respect to the terms and conditions determined, if any, by the health section of the Sectoral Committee on Social Security and Health in respect of communication.
If a personal data communication is already taking place at the time of the coming into force of this Act and, pursuant to this section, requires an authorization in principle of the health section of the Social Security Sector Committee, the Health Section grants its authorization in principle for this communication within one year after the coming into force of this Act. The communication in question is discontinued if the authorization is not granted in the year following the coming into force of this Act or if the health section of the Social Security and Health Sector Committee explicitly states that it does not grant authorization for the communication. When carrying out the communication, the terms and conditions determined, if any, by the Health Section of the Sectoral Committee on Social Security and Health with respect to communication are respected.
Art. 12. The King may, by order deliberately in the Council of Ministers, after the advice of the Management Committee and after the advice of the Commission on the Protection of Privacy, determine which data must be communicated by which public institutions to the eHealth platform, and by electronic means, in order to carry out the missions of the latter and which data must be communicated by the eHealth platform to which public institutions, and by electronic means, for the latter.
Art. 13. The data provided electronically on the eHealth platform, as well as their reproduction on a readable medium, have, until proof of the contrary, the same probative value as if it had been communicated on paper.
Art. 14. The King sets out the operating procedures of the eHealth platform and the registration of the software referred to in Article 5, 3°.
Following the advice of the Privacy Commission, it may set out the security rules that it considers useful and the terms and conditions for its application.
CHAPTER 5. - eHealth platform management
Art. 15. § 1^er. The eHealth platform is managed by a Management Committee that includes a Chair, with a deliberate vote, and thirty-one members, including:
1° the following members who have a deliberate vote:
(a) seven members proposed by the National Intermutualist College;
(b) seven health care providers proposed by the members of the Health Care Insurance Committee of the National Institute of Disability Health Insurance referred to in Article 21, § 1^erParagraph 1^er(b) to (e) of the Compulsory Health Care Insurance Act, coordinated on 14 July 1994, including at least three representatives of physicians and two representatives of care facilities;
(c) two members proposed by the National Disability Insurance Institute;
(d) two members proposed by the Federal Public Service Public Health, Food Chain Safety and Environment;
(e) a member proposed by the Federal Public Service Social Security;
(f) a member proposed by the Federal Centre for Health Care Expertise;
(g) a member proposed by the Federal Agency for Drugs and Health Products;
2° the following members who have a consultative voice, except with regard to the definition of the vision, mission and strategic plan of the eHealth platform, for which they have a deliberate voice:
(a) a member appointed and dismissed by the Minister with Public Health in his or her functions;
(b) a member appointed and dismissed by the Minister with social affairs in his or her functions;
(c) a member appointed and dismissed by the Minister with the State Computerization in his or her powers;
(d) a member appointed and dismissed by the appropriate Minister for Budget;
3° the following members who have an advisory vote:
(a) two members appointed and dismissed by the Management Committee of the Social Security Bank among the representatives in the Management Committee of the most representative organizations of the employers and the most representative organizations of the self-employed;
(b) two members appointed and revoked by the Management Committee of the Social Security Bank among the representatives in the Management Committee of the most representative organizations of the employed workers;
(c) a member proposed by the College of Physicians;
(d) a member proposed by the College of Pharmacists.
Members referred to in paragraph 1^er, 1°, and in paragraph 1^er, 3°, c) and d), are appointed and revoked by the King. In any case, they are revoked if the proceeding that proposed the application. These members are appointed for a period of six years. This period is renewable.
The King also appoints, on the same terms, alternates for members of the Administrative Committee.
The President is appointed by the King, on the proposal of the Ministers, for a term of six years. The President is a person with a deliberate vote. In case of voice sharing, his voice is preponderant.
§ 2. The President ' s administrative and financial status and the allowances and attendance of the members of the Management Committee are determined by the King.
§ 3. The eHealth Platform Management Committee establishes its rules of procedure and submits it to the Ministers for approval.
§ 4. As part of the legal and regulatory provisions, the Management Committee is competent to perform all acts of administration and provision that are necessary for the management of the eHealth platform.
These include management tasks, approval of the strategy and vision of the eHealth platform, the preparation of the budget proposal and the monitoring of its execution, the establishment of the annual revenue and expenditure account and the determination of the active and passive situation as of December 31 of the eHealth platform.
§ 5. The Management Committee may use the collaboration of individuals and institutions or services created either by public administrations or by private individuals to carry out the eHealth platform's tasks.
§ 6. The Managing Director of the Carrefour Social Security Bank is responsible for the daily management of the eHealth platform. If the deputy head is prevented, his powers are exercised by the deputy head of the Carrefour Bank of Social Security or, in the absence of the latter, by a staff member of the Carrefour Bank of Social Security appointed by the eHealth Platform Management Committee.
The person responsible for the day-to-day management of the eHealth platform is assisted by a Director General in carrying out the tasks specific to the eHealth platform.
The person responsible for the day-to-day management of the eHealth platform shall execute the decisions of the Management Committee; It gives the latter all information and submits any proposals useful to the operation of the organization. This person and the general manager referred to in paragraph 2 attend the meetings of the eHealth Platform Management Committee.
The person responsible for the day-to-day management of the eHealth platform directs the staff and, under the authority and control of the eHealth Platform Management Committee, ensures the operation of the organization. It exercises the daily management powers defined by the rules of procedure. The Management Committee may delegate other specific powers to it.
To facilitate the shipment of cases, the eHealth Platform Management Committee may, within the limits and conditions it determines, authorize the person called upon to assume the day-to-day management to delegate some of the powers conferred upon him, as well as the signature of certain documents and correspondences.
The person responsible for the day-to-day management of day-to-day management represents the organization in judicial and extrajudicial acts and acts on its behalf and on its behalf without having to justify a decision of the eHealth Platform Management Committee.
However, with the agreement of the eHealth Platform Management Committee, it may delegate to one or more staff members its authority to represent the organization before administrative courts in disputes relating to rights arising from social security regulations.
For judicial and non-judicial acts, other than those referred to in paragraph 6, the organization is represented by the person responsible for day-to-day management and by the President who, jointly, act in his or her behalf. In the event of the President's failure, the chair is replaced by a member of the eHealth Platform Management Committee designated by this committee. In the event of the absence or incapacity of the President, the person responsible for Daily Management and his deputy, the acts are performed jointly by two members appointed by the eHealth Platform Management Committee.
Art. 16. The monitoring of the eHealth platform is ensured through two government commissioners appointed by the King. One of the government commissioners is appointed on the proposal of the ministers, the other on the proposal of the minister having the budget in his office.
Art. 17. The eHealth platform is assimilated to the State for the application of the laws on the rights of stamps, grafts and mortgages, on taxes assimilated to the stamp, as well as on other direct or indirect taxes. It is exempt from all taxes or taxes for the benefit of the provinces and municipalities.
Art. 18. The Carrefour de la sécurité sociale Bank provides the eHealth platform for retribution, services, personnel, equipment and facilities necessary for the operation of the eHealth platform.
CHAPTER 6. - Financing eHealth platform
Art. 19. The eHealth platform can be funded by:
1° an annual allocation included in the federal Public Service budget Public Health, Food Chain Safety and Environment;
2° an annual allocation included in the Federal Public Service budget Social Security;
3° an annual amount dependant on the administration costs of the National Institute of Disability Health Insurance;
4° of revenues from other federal authorities;
5° of service products provided to local, regional or community governments;
6° of service products provided to third parties;
7° with the agreement of the Minister with Finance in his or her powers the proceeds of the investment of financial reserves;
8° of gifts and bequests;
9° of casual income.
CHAPTER 7. - Staff
Art. 20. As part of the creation of the eHealth platform, the King can transfer contract and statutory agents from the Federal Public Service Public Health, Food Chain Safety and Environment, the Federal Public Service Social Security, the National Institute for Disability Health Insurance or another public service to the eHealth platform.
The King sets the rules for the transfer of personnel by order deliberately in the Council of Ministers.
This transfer of staff to the eHealth platform is done with maintaining grade and quality. The agents concerned retain the advantage of their administrative and financial seniority.
Art. 21. A person who, because of his or her functions, participates in the collection, processing or communication of personal data by the eHealth platform or is aware of such data is required to respect the confidentiality of such data; However, it is released from this obligation when it is called upon to testify in court, as part of the exercise of the right of inquiry conferred on the Chambers by section 56 of the coordinated Constitution or as part of the investigation of a case by the Sectoral Committee on Social Security and Health, or where the law provides or obliges it to make known what it knows.
CHAPTER 8. - eHealth Platform User Consultation Committee
Art. 22. It is created with the eHealth platform an eHealth user consultation committee for the eHealth platform. The Committee for Consultation assists the Management Committee of the eHealth platform in carrying out its tasks. To this end, it is responsible for proposing any initiatives to promote and consolidate the provision of electronic services to health care actors and any measures that may contribute to the secure and confidential treatment of personal health data or administrative simplification for health care actors.
The Consultative Committee may also establish working groups in which it assigns specific tasks. It establishes its rules of procedure and submits it to the eHealth Platform Management Committee for approval.
Art. 23. The Coordinating Committee is chaired by a doctor. The King shall, by order deliberately in the Council of Ministers, determine the composition of the Committee of Consultation, specify, where appropriate, its powers, establish its modalities of operation and appoint its president.
The King also determines the amount and conditions for the granting of attendance tokens and residence allowances or work expenses to be paid to the members of the Consultation Committee or to the experts to whom it is appealed, as well as the conditions for the reimbursement of their travel expenses.
The King may also determine the cases in which consultation with the Consultation Committee is mandatory.
The eHealth platform is responsible for the operational costs of the Consultation Committee and the working groups established within it and provides the secretariat.
CHAPTER 9. - Amendments
Art. 24. Article 17bis of the Law on the Carrefour Bank of Social Security, replaced by the Law of 24 December 2002 and amended by the Laws of 8 April 2003, 22 December 2003 and 27 December 2005, by the Royal Decree of 12 June 2006 and by the Law of 1^er March 2007, the following amendments are made:
1° in paragraph 1^er, it is inserted a 3°bis written as follows:
"the eHealth platform and the association referred to in section 37 of the law of [...] relating to the institution and organization of the eHealth platform;"
2° in paragraph 2, the words "seen to § 1^er, 1°, 1°bis, 2°ter, 3°, 4°, 5°, 6°, 7° or 8° are replaced by the words "vised in § 1^er, 1°, 1°bis, 2°ter, 3°, 3°bis, 4°, 5°, 6°, 7° or 8°".
Art. 25. In Article 35, § 1^er, of the same law, inserted by the law of 27 December 2005, it is inserted a 2°ter, written as follows:
"2°ter une participation de la plate-forme eHealth, qui couvert les frais borne par la Banque Carrefour en œuvre de l'article 18 de la loi du [...] relative à l'institution et à l'organisation de la plate-forme eHealth pour la mise à disposition de services, de personnel, de l'information et des installations nécessaires au fonctionnement de la plate-forme eHealth;".
Art. 26. Article 37, § 2, of the same law, replaced by the law of 1^er March 2007, the following amendments are made:
1°) the 3° is replaced by the following:
"3° of two external members with the quality of a doctor or law graduate, which are part of the social security section; ";
2°) the 6° is replaced by the following:
"6° of three external members with the medical quality, an expert in health data management, who are part of the health section."
Art. 27. In section 38, paragraph 2, of the Act, replaced by the Act of 26 February 2003 and amended by the Act of 1^er March 2007, the words "Cinq alternate external members" are replaced by the words "Sept alternate external members".
Art. 28. In Article 39, § 1^er, 3°, of the same law, replaced by the law of 1^er March 2007, the words "of the eHealth platform referred to in section 2 of the law of [...] relating to the institution and organization of the eHealth platform," are inserted between the words "to be independent" and the words "of the Federal Public Service Public Health, Food Chain Safety and Environment".
Art. 29. Article 42, § 2, of the same law, replaced by the law of 1^er March 2007, is replaced by the following:
“§2. In accordance with Article 31bis, § 3, of the aforementioned Law of 8 December 1992, the eHealth platform, referred to in Article 2 of the Law of [...] relating to the institution and organization of the eHealth platform, is responsible for drafting the technical and legal advice concerning any request for the communication of personal data relating to health within the meaning of the above-mentioned Law of 8 December 1992, which it received a copy of The chair of the Social Security and Health Sector Committee or the eHealth platform may decide to appeal, for the drafting of the technical and legal advice, to the support of the Federal Public Service Public Health, Food Chain Safety and Environment, the National Institute for Disability Insurance, the Federal Centre for Health Care Expertise or the foundation referred to in Article 45quinquies of the Royal Decree No. 78 November to the 1967 Federal Centre for Health Care. »
Art. 30. Section 43 of the Act, replaced by the Act of 26 February 2003 and amended by the Act of 1^er March 2007, the following amendments are made:
(a) paragraph 1^er is replaced by the following:
"Art. 43. The operating costs of the two sections of the Social Security and Health Sector Committee are covered by the Bank-Carrefour, with the exception of:
1° of the allowances and reimbursements for costs to their members, which are covered by the Privacy Commission;
2° the costs of drafting the technical and legal advice referred to in Article 42, § 2, which are borne by the eHealth platform referred to in Article 2 of the law of [...] relating to the institution and organization of the eHealth platform;
3° of the costs for the support of the Federal Public Service Public Health, Safety of the Food Chain and Environment, the National Institute of Disability Insurance, the Federal Centre for Health Care Expertise or the foundation referred to in Article 45quinquies of Royal Decree No. 78 of 10 November 1967 relating to the exercise of health care professions, referred to in Article 42, § 2 in fine, which are, if any, supported by the institution
(b) in paragraph 2, the words "a part-time mission at 20%" are replaced by the words "a part-time mission at 50%";
(c) in paragraph 3, the words "with an amount equal to 20%" are replaced by the words "with an amount equal to 50%".
Art. 31. ÷ section 45, paragraph 3, of the Carrefour Bank of Social Security Act, replaced by the Act of 26 February 2003 and amended by the Act of 1^er March 2007, paragraph 3 is replaced by the following:
"The senior official of the eHealth platform attends meetings of the Health Section of the Sectoral Committee on Social Security and Health with an advisory voice. »
CHAPTER 10. - Other provisions
Art. 32. § 1^er. Without changing the general scope of the provisions, the King may, by order deliberately in the Council of Ministers, repeal, supplement, amend or replace the applicable legal provisions insofar as they relate to processes that involve the exchange of personal data on paper and where this repeal, this Health completely, this modification or replacement are necessary so that this exchange of personal data can now be carried out electronically, to the intervention e
To the extent that an order made under paragraph 1^er may have an impact on this Act or on the Act of 8 December 1992 on the protection of privacy with respect to personal data processing, the Act of 22 August 2002 on the rights of the patient or their respective enforcement orders, the Commission on the Protection of Privacy shall render its notice beforehand.
§ 2. Orders taken in accordance with § 1^er cease to produce their effects at the end of the thirteenth month following their entry into force, if they have not been confirmed by law before that date.
Art. 33. The Royal Decree of 3 May 1999 establishing a Commission "Telematic Standards for the Health Care Sector" is repealed on the date determined by the King.
On the date and in accordance with the terms and conditions determined by the King, the eHealth platform resumes the Commission's tasks "Telematic Standards for the Health Care Sector", as well as the rights and obligations arising from the tasks carried out so far.
Art. 34. Section 4 of the Act of 27 December 2006 on various provisions (I) is repealed.
Art. 35. On the date and in accordance with the terms and conditions determined by the King, the eHealth platform takes over the rights and obligations arising from the measures taken for the entry into force of eHealth platform, for the preparation and realization of its development and installation.
Art. 36. Two years after the coming into force of this Act, the Ministers report to the Legislative Chambers on the application of this Act with the addition, if any, of recommendations that may result in a legislative initiative or other measures for the proper enforcement of this Act. Their report is based on an evaluation report on the eHealth platform itself and an evaluation report on the health section of the social security and health sector committee.
CHAPTER 11. - Authorization of association
Art. 37. The State and the National Institute of Disability Health Insurance can, together with the insurance organizations referred to in the Compulsory Health Care and Allowance Insurance Act, coordinated on 14 July 1994, and with the associations of care providers and care institutions, establish a non-profit association, within the meaning of the law of 27 June 1921 on non-profit associations, international non-profit associations and foundations, for the purpose of promotion
A representative of the eHealth platform participates with an advisory voice in meetings of the management bodies of the association.
This association may be responsible for:
1° to determine the organization of electronic data streams for the collection, processing and provision of clinical data relating to repayable benefits through compulsory health care and allowance insurance and to entrust the operational organization of these data streams to one or more of its members or to the eHealth platform;
2° to determine the organization of records relating to different clinical areas and to entrust the operational organization of these registers to one or more of these members or to the eHealth platform;
3° to collect anonymous and coded data and to make them available to the Federal Centre for Health Care Expertise and to institutions or scientific associations for scientific studies.
The missions of this association do not prejudice the competence of the Sectoral Committee on Social Security and Health with regard to the granting of authorizations for personal health data communications.
The statutes of this association are submitted for approval to Ministers with Social Affairs and Public Health in their responsibilities. The annual accounts of this association are submitted for approval by the Minister of Budget.
Art. 38. The association created pursuant to section 37 does not have a clean information system for electronic data exchange, register management or data coding and anonymization.
The persons to whom the operational organization of data streams or the management of registers is entrusted pursuant to Article 37, paragraph 3, 1 and 2°, use the basic services developed by the eHealth platform pursuant to Article 5, 4°, b).
The coding and anonymization of the data referred to in section 37, paragraph 3, is operated by the eHealth platform.
Art. 39. The association established pursuant to Article 37 shall involve representatives of the caregivers of the clinical field concerned to determine any data streams or data streams referred to in Article 37, paragraph 3, 1°, and any registers or registers referred to in Article 37, paragraph 3, 2°.
These representatives put forward proposals on the nature of the data to be collected and on the organization of the data stream or the register concerned.
Art. 40. The association created pursuant to Article 37 may be financed by:
1° an annual allocation included in the Federal Public Service budget Public Health, Food Chain and Environment Safety;
2° an annual amount dependant on the administration costs of the National Institute of Disability Health Insurance;
3° of service products provided to local, regional or community governments;
4° of service products provided to third parties;
5° of gifts and bequests;
6° of casual income.
Promulgate this law, order that it be clothed with the seal of the State and published by the Belgian Monitor.
Given at Châteaneuf-de-Grasse, August 21, 2008.
ALBERT
By the King:
Minister of Social Affairs and Public Health,
Ms. L. ONKELINX
Seal of the state seal:
Minister of Justice,
J. VANDEURZEN
____
Note
(1) Regular session 2007-2008.
Documents. - Bill, 52. - 1257, No. 1. - Amendments 52. - 1257, No. 2. - Report, 52. - 1257, No. 3. - Text adopted by the Commission, 52. - 1257, No. 4. - Amendments filed after report, 52. - 1257, number 5.
Full report. - 10 July 2008.