What changed in the EU for wearables with the EHDS agreement?

The European Health Data Space sets new rules for consent, portability, and secondary use of health data, requiring interoperable export mechanisms and clearer user disclosures. It targets fragmentation across member states and establishes pathways for research-oriented data access under strict governance.

How does the FDA’s guidance affect wearable data in clinical trials?

FDA’s updated materials refine expectations for validation, sampling, data integrity, and cybersecurity when wearable data are used as endpoints. Sponsors must demonstrate fit-for-purpose sensors, robust data pipelines, and auditability to ensure evidence withstands regulatory scrutiny.

What are the main compliance challenges for enterprises using wearables?

Enterprises must manage granular consent, standardized exports, and strict secondary-use boundaries, especially when data flow to wellness programs or research partners. They also need robust cybersecurity controls, audit logs, and contractual clauses that map to EHDS and FDA requirements.

What’s the near-term outlook for regulatory enforcement in wearables?

Expect increased scrutiny of opaque data sharing and weak security practices, with regulators pushing for transparency and strong evidence standards. Vendors with adaptable data architectures and clear separations between wellness features and clinical endpoints are best positioned to navigate the next wave.

EU Health Data Deal, FDA Wearables Guidance Force Apple, Google, Samsung to Rewire Data

Q: How are Apple, Google’s Fitbit, Samsung, Garmin, Oura and Whoop responding?

These vendors are updating consent flows, data portability tools, and documentation to align with EHDS and FDA expectations. EU users should see clearer just-in-time notices and export options, while U.S. trials will reflect stronger validation annexes and security attestations.

Europe’s health-data pact and fresh U.S. guidance on wearable-derived evidence are reshaping compliance for consumer and enterprise wearables. Apple, Google’s Fitbit, Samsung, Garmin, Oura and Whoop are accelerating privacy controls, data portability and validation pipelines as regulators move from draft rules to enforcement.

Published: November 24, 2025 By Aisha Mohammed Category: Wearables

EU Health Data Deal, FDA Wearables Guidance Force Apple, Google, Samsung to Rewire Data

Europe Locks In Health Data Access: EHDS Deal Sets New Rules

On November 12, 2025, EU negotiators announced a political agreement on the European Health Data Space (EHDS), a framework designed to standardize consent, portability, and secondary use of health data across member states. The deal introduces obligations for device makers to provide interoperable export mechanisms and transparent consent flows for wearable-derived health records, according to the European Parliament’s summary of the agreement published this month. The EHDS dovetails with the EU’s broader data-sharing regime, reinforcing requirements that connected products expose user-accessible data and APIs when individuals opt to share their information.

Regulators say the EHDS aims to reduce fragmentation in cross-border health data and support research, with tougher disclosure and audit trails for data brokers and digital health platforms. For more on related telecoms developments. Early industry briefings note that personal wellness and medical-grade wearables will need clear labeling around primary versus secondary use, plus standardized pathways for exporting raw and processed signals, as outlined by the European Commission. Analysts expect compliance programs to focus on identity assurance, consent lifecycles, and data minimization to avoid penalties tied to unlawful processing or opaque data sharing, Reuters reported in coverage of the deal.

FDA Tightens Evidence Standards for Wearables in Trials

In the United States, the Food and Drug Administration updated guidance this month on the use of digital health technologies (DHTs)—including consumer wearables—for remote data acquisition in clinical investigations. The document clarifies validation expectations for sensors, sampling frequency, data integrity, and cybersecurity controls when wearable data support primary or secondary endpoints, reinforcing Good Clinical Practice-aligned procedures and auditability. The agency’s published materials emphasize fit-for-purpose metrics and endpoint justification, with recommended checks for drift, missingness, and participant adherence, according to FDA guidance on DHTs for clinical investigations.

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