Final EU approval of the health data legislation is expected to occur on April 24. It is part of the EU’s ambitious data strategy, and the first Union legislation creating a sector-specific European data space. The European Health Data Space (EHDS) regulation would create new patient rights with respect to personal electronic health data, including rights of access. Electronic health record systems would be required to undergo pre-market conformity assessments. In addition, member state authorities would issue permits to data users—public authorities, universities, and private companies—that wish to re-use pseudonymized or anonymized health data for secondary purposes, such as research, innovation, policy-making and regulatory activities. The regulation further envisages transfers of personal data outside the EU, but under restrictive conditions similar to those in General Data Protection Regulation, the Data Governance Act, and the Data Act.

Is the EHDS regulation an important advance in protecting personal electronic health data and in setting the stage for valuable secondary uses? How does the EHDS compare to US health data regulation, including recent efforts by the Federal Trade Commission establishing national standards for handling personal electronic health data? Does it create new problems for transatlantic data transfers?

Against this backdrop, senior experts from the US Government, European Commission, academia, and private industry will unpack the implications of the EHDS regulation.

ORIGINAL AIRDATE: 4/26/24