Category

Health Data & Privacy

Health data is among the most sensitive categories of personal data and is subject to layered regulation. In Europe the General Data Protection Regulation treats health data as a special category with strict conditions for processing, while the European Health Data Space establishes rules for both the primary use of health data in care and its secondary use in research and policy-making. This page collects the updates HealthSignal tracks on the EHDS, GDPR guidance for healthcare, interoperability, and national data protection developments, from official public bodies.

Regulation Category Impact Date

AMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.953v01-00

AMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...

European Parliament - SANT Subcommittee (Public Health)
Digital Health & AIClinical Trials
Medium
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AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.939v01-00

AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...

European Parliament - SANT Subcommittee (Public Health)
Digital Health & AIClinical Trials
Medium
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DRAFT REPORT on the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs - PE789.094v01-00

DRAFT REPORT on the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and...

European Parliament - SANT Subcommittee (Public Health)
General RegulatoryHealth Data & Privacy
Low
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Guidance: Operational Information Sharing

Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process.

UK MHRA
Health Data & PrivacyPharmaceuticals
Medium
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What is the EHDS Regulation about

The European Health Data Space (EHDS) is a cornerstone of theEuropean Health Unionand thefirst common EU data spacededicated to a specific sector as part of theEuropean strategy for data.

European Health Data Space
Health Data & PrivacyGeneral Regulatory
Medium
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France HDS Certification - New Standards Mandatory

All health data hosting providers must comply with updated HDS (Hébergeur de Données de Santé) certification standards. Digital health companies processing French patient data must use HDS-certified infrastructure. AN...

ANS - French Digital Health Agency
Health Data & PrivacyDigital Health & AI
High
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EHDS Full Implementation (Primary + Secondary)

Complete EHDS infrastructure operational for primary use (patient care data exchange) and secondary use (research access). Healthcare providers must implement electronic health data access. EHR manufacturers must comp...

European Health Data Space
Health Data & PrivacyDigital Health & AI
High
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EHDS Primary Use Infrastructure Operational

MyHealth@EU infrastructure for primary use (patient care) must be operational. Cross-border exchange of Patient Summaries and ePrescriptions/eDispensations becomes mandatory. Healthcare providers must enable electroni...

European Health Data Space
Health Data & PrivacyDigital Health & AI
Medium
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PharmaceuticalsMedical DevicesDigital Health & AIClinical TrialsMarket Access & ReimbursementGeneral Regulatory