Significant Changes Ahead in Health Tech Regulations for 2025
Global, Tuesday, 7 January 2025.
The health tech sector is set for major regulatory shifts in 2025, affecting digital innovations and healthcare technology deployment.
HIPAA Security Rule Overhaul
The Department of Health and Human Services (HHS) has initiated the most substantial update to the HIPAA Security Rule in over a decade [3]. On January 6, 2025, HHS proposed comprehensive modifications that include mandatory requirements for multifactor authentication, network segmentation, and bi-annual vulnerability scanning [3]. These changes are driven by the increasing sophistication of cyberattacks in healthcare, with HHS Deputy Secretary Andrea Palm emphasizing the direct threat to patient safety [3]. Healthcare organizations will have 60 days to provide feedback on this nearly 400-page proposal [3].
AI Transparency Requirements Take Effect
A groundbreaking federal transparency rule has come into force at the start of January 2025, requiring electronic health record (EHR) companies to provide detailed information about their AI tools [5]. This new regulation mandates the disclosure of ‘model cards’ or ‘nutrition labels’ that outline prediction variables, real-world testing data, and potential bias assessments [5]. This development marks a significant step toward greater accountability in healthcare AI implementations [GPT].
European Union Strengthens Health Tech Oversight
The European Union has demonstrated its commitment to enhancing health technology assessment with the activation of six new EU reference laboratories on January 3, 2025 [4]. This initiative follows the EU’s recent adoption of rules for joint scientific consultations on medicinal products in December 2024 [4]. The COMBINE programme for clinical trials and medical devices, endorsed by Member States, signals a more coordinated approach to health technology evaluation across the EU [4].
Legal and Compliance Implications
Healthcare organizations are preparing for increased regulatory scrutiny and potential litigation as these new rules take effect [1]. Industry experts from Orrick, Herrington & Sutcliffe LLP note that the changing administration and implementation of new regulations will significantly impact healthcare technology deployment [1][2]. Healthcare providers and technology companies must adapt their compliance strategies to address these evolving requirements while maintaining operational efficiency [2].