Article 81*

Article 81 – Processing of personal data concerning health

Commission Proposal

1. Within the limits of this Regulation and in accordance with point (h) of Article 9(2), processing of personal data concerning health must be on the basis of Union law or Member State law which shall provide for suitable and specific measures to safeguard the data subject’s legitimate interests, and be necessary for:

(a) the purposes of preventive or occupational medicine, medical diagnosis, the provision of care or treatment or the management of health-care services, and where those data are processed by a health professional subject to the obligation of professional secrecy or another person also subject to an equivalent obligation of confidentiality under Member State law or rules established by national competent bodies; or

(b) reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety, inter alia for medicinal products or medical devices; or

(c) other reasons of public interest in areas such as social protection, especially in order to ensure the quality and cost-effectiveness of the procedures used for settling claims for benefits and services in the health insurance system.

2. Processing of personal data concerning health which is necessary for historical, statistical or scientific research purposes, such as patient registries set up for improving diagnoses and differentiating between similar types of diseases and preparing studies for therapies, is subject to the conditions and safeguards referred to in Article 83.

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 86 for the purpose of further specifying other reasons of public interest in the area of public health as referred to in point (b) of paragraph 1, as well as criteria and requirements for the safeguards for the processing of personal data for the purposes referred to in paragraph 1.

Go to related Recital 122

Go to related Recital 123

EDRi’s proposed amendment:

1. Within the limits of Without prejudice to this Regulation and in accordance with point (h) of Article 9(2), processing of personal data concerning health must be on the basis of Union law or Member State law which shall provide for suitable and specific measures to safeguard the data subject’s legitimate interests, and be necessary for:

(a) the purposes of preventive or occupational medicine, medical diagnosis, the provision of care or treatment or the management of health-care services, and where those data are processed by a health professional subject to the obligation of professional secrecy or another person also subject to an equivalent obligation of confidentiality under Member State law or rules established by national competent bodies; or

(b) reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety, inter alia for medicinal products or medical devices; or

(c) other reasons of public interest in areas such as social protection, especially in order to ensure the quality and cost-effectiveness of the procedures used for settling claims for benefits and services in the health insurance system.

When the purposes mentioned in points (a) – (c), above, can be achieved without the use of personal data, such data shall not be used for those purposes.

2. Subject only to the exception in paragraph (3), processing of personal data concerning health which is necessary for historical, statistical or scientific research purposes [ ] shall be permitted only with the consent of the data subjects, given in accordance with Article 4(8), and in addition shall be subject to the conditions and safeguards referred to in Article 83.

3. Member States may by law provide for exceptions to the requirement of consent for research, stipulated in paragraph (2), with regard to research that serves exceptionally high public interests, if that research cannot possible be carried out otherwise.  The data in question shall be anonymised or pseudonymised to the highest possible standards, and all possible measures shall be taken to prevent re-identification of the data subjects.  Such processing shall be subject to prior authorisation of the relevant national supervisory authority or authorities, in accordance with Article 34(1) of this Regulation, and to the Consistency Mechanism provided for in Chapter VII, Section 2, of this Regulation.

4. The Commission shall be empowered to adopt delegated acts in accordance with Article 86 for the purpose of further specifying other reasons of public interest in the area of public health as referred to in point (b) of paragraph 1, as well as criteria and requirements for the safeguards for the processing of personal data for the purposes referred to in paragraph 1.

Justification

While the processing of personal data relating to health can bring certain benefits with it, it should -in view of the inherent sensitivity of such data- be restricted as far as possible. This amendment proposes additional rules to this end.

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