Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
EHDS Article 52. Intellectual property rights and trade secrets
- 1.Electronic health data protected by intellectual property rights, trade secrets or covered by the regulatory data protection right laid down in Article 10(1) of Directive 2001/83/EC of the European Parliament and of the Council or Article 14(11) of Regulation (EC) No 726/2004 of the European Parliament and of the Council shall be made available for secondary use in accordance with the rules laid down in this Regulation.
- 2.Health data holders shall inform the health data access body of any electronic health data containing content or information protected by intellectual property rights, trade secrets or covered by the regulatory data protection right laid down in Article 10(1) of Directive 2001/83/EC or Article 14(11) of Regulation (EC) No 726/2004. Health data holders shall identify which parts of the datasets are concerned and justify the need for the specific protection of the data. Health data holders shall provide that information when communicating to the health data access body the description of the dataset they hold pursuant to Article 60(3) of this Regulation or, at the latest, following a request received from the health data access body.
- 3.Health data access bodies shall take all specific appropriate and proportionate measures, including of a legal, organisational and technical nature, they deem necessary to protect the intellectual property rights, trade secrets or the regulatory data protection right laid down in Article 10(1) of Directive 2001/83/EC or Article 14(11) of Regulation (EC) No 726/2004. Health data access bodies shall remain responsible for determining whether such measures are necessary and appropriate.
- 4.When issuing data permits in accordance with Article 68, health data access bodies may make the access to certain electronic health data conditional on legal, organisational and technical measures, which may include contractual arrangements between health data holders and health data users for the sharing of data containing information or content protected by intellectual property rights or trade secrets. The Commission shall develop and recommend non-binding models of contractual terms for such arrangements.
- 5.Where the granting of access to electronic health data for secondary use entails a serious risk of infringing intellectual property rights, trade secrets or the regulatory data protection right laid down in Article 10(1) of Directive 2001/83/EC or Article 14(11) of Regulation (EC) No 726/2004 which cannot be addressed in a satisfactory manner, the health data access body shall refuse access to the health data applicant to such data. The health data access body shall inform the health data applicant of, and provide to the health data applicant a justification for, that refusal. Health data holders and health data applicants shall have the right to lodge a complaint in accordance with Article 81 of this Regulation.
Relevant Recitals for this Article
Electronic health data protected by intellectual property rights or trade secrets, including data on clinical trials, investigations and studies, can be very useful for secondary use and can foster innovation within the Union for the benefit of Union patients. In order to incentivise continuous Union leadership in this domain, it is important to encourage the sharing of clinical trials and clinical investigations data through the EHDS for secondary use. Clinical trials and clinical investigations data should be made available to the extent possible, while taking all necessary measures to protect intellectual property rights and trade secrets. This Regulation should not be used to reduce or circumvent such protection and should be consistent with the relevant transparency provisions laid down in Union law, including for clinical trials and clinical investigations data. Health data access bodies should assess how to preserve such protection while enabling access to such data for health data users to the extent possible. If a health data access body is unable to provide access to such data, it should inform the health data user and explain why it is not possible to provide such access. Legal, organisational and technical measures to protect intellectual property rights or trade secrets could include common electronic health data access contractual arrangements, specific obligations within the data permit in relation to such rights, pre-processing the data to generate derived data that protect a trade secret but nonetheless have a utility for the health data user or configuration of the secure processing environment so that such data are not accessible to the health data user.