On December 29, 2025, the U.S. Department of Health and Human Services (“HHS”), through the Assistant Secretary for Technology Policy (“ASTP”)/Office of the National Coordinator for Health Information Technology (“ONC”) (collectively, “ASTP/ONC”), issued a proposed rule to update its Health Data, Technology, and Interoperability (“HTI”) regulations, as well as a notice to withdraw prior proposals issued as part of the HTI-2 proposed rule. Continue Reading HHS Proposes Changes to the Health IT Certification Program and Information Blocking Regulations in HTI-5 Proposed Rule
5 Developments Digital Health Innovators Should Watch in 2026
With 2026 underway, signs point to another year focused on enhancing health IT and digital health innovation. From new payment models to deregulatory efforts, these developments show that digital health continues to be increasingly central to the healthcare and life sciences sectors. Below are five key developments to watch unfold
Continue Reading 5 Developments Digital Health Innovators Should Watch in 2026What Life Sciences and Digital Health Companies Need to Know About CMS’s New Health Technology Ecosystem Initiative
On July 30, 2025, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) announced a new Health Technology Ecosystem Initiative—a collaborative effort between government and industry to unlock innovation by modernizing healthcare data flows among patients, providers, payers, and technology platforms. The new initiative does not contemplate any new regulations; instead, it is a CMS-led effort intended to empower and accelerate innovation by the private sector through (i) the development of public digital infrastructure and data standards and (ii) voluntary commitments from industry to deliver new technology solutions based on a common data-sharing framework.
It is too early to predict how successful the Health Technology Ecosystem will be—the stubborn prevalence of data silos, lack of interoperability between systems, and challenges with using data for secondary purposes have long been a hurdle to innovation—yet, with 60 organizations, including leading tech firms, already pledging support for the new initiative, the broader industry may see this as an occasion for renewed focus and expanded efforts to bring health technology solutions to market at scale. For life sciences and digital health companies, this new initiative may present a strategic opportunity to better serve patients, empower providers, improve real-world evidence generation, and support innovation leading to better healthcare outcomes. Continue Reading What Life Sciences and Digital Health Companies Need to Know About CMS’s New Health Technology Ecosystem Initiative
The UK’s new Data Legislation – What does it mean for the Life Science sector?
This blog was prepared in collaboration with, and was originally published by, the UK BioIndustry Association, here. We are grateful to the UK BioIndustry Association for collaborating on this blog, and for the opportunity to post it here.
What are the UK’s plans to reform data protection law?
After
Continue Reading The UK’s new Data Legislation – What does it mean for the Life Science sector?Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices
On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog
Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesFTC Issues Final Rule to Expand Scope of the Health Breach Notification Rule
On Friday, April 26, 2024, the Federal Trade Commission (“FTC”) voted 3-2 to issue a final rule (the “final rule”) that expands the scope of the Health Breach Notification Rule (“HBNR”) to apply to health apps and similar technologies and broadens what constitutes a breach of security, among other updates. We previously covered the proposed rule, which was issued on May 18, 2023.Continue Reading FTC Issues Final Rule to Expand Scope of the Health Breach Notification Rule
EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective
In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focusses on the obligations of data users; for an overview of the EHDS generally, see our first post in this series.
We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective
EHDS Series – 2: The European Health Data Space from the Health Data Holder’s Perspective
In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focusses on the obligations of data holders; for an overview of the EHDS generally, see our first post in this series.
We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 2: The European Health Data Space from the Health Data Holder’s Perspective
EHDS Series – 1: Five Key Take Aways on Secondary Use of Health Data
In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.
We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 1: Five Key Take Aways on Secondary Use of Health Data
Senator Cassidy Issues White Paper with Proposals to Update Health Data Privacy Framework – Part 2: Safeguarding Health Data Not Covered by HIPAA
Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, published on February 21, 2024, a white paper with various proposals to update privacy protections for health data. In Part 1 of this blog series (see here), we discussed the first section of Senator Cassidy’s February 21, 2024, white paper. Specifically, we summarized Senator Cassidy’s proposals on how to update the existing framework of the Health Insurance Portability and Accountability Act, as amended, and its implementing regulations (collectively, “HIPAA”) without disrupting decades of case law and precedent. In this blog post, we discuss the other sections of the white paper, namely proposals to protect other sources of health data not currently covered by HIPAA.Continue Reading Senator Cassidy Issues White Paper with Proposals to Update Health Data Privacy Framework – Part 2: Safeguarding Health Data Not Covered by HIPAA