On 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare
Latest from Covington Digital Health
Biden Administration Rulemakings at Risk for Congressional Review Act Cancellation in New Congress
In a new post on the Inside Privacy blog, our colleagues discuss the potential risk for Congressional Review Act (CRA) cancellation of Biden Administration rulemakings under the newly assembled 119th Congress.
HHS Issues Notice of Proposed Rulemaking to Update the HIPAA Security Rule
On January 6, 2025, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued a notice of proposed rulemaking (the “proposed rule”), which proposes a number of significant updates to the HIPAA Security Rule. According to
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
Quantum Computing: Developments in the UK and US
This update focuses on how growing quantum sector investment in the UK and US is leading to the development and commercialization of quantum computing technologies with the potential to revolutionize and disrupt key sectors. This is a fast-growing area that
FDA Announces Workshop on AI Used In Drug & Biological Product Development
FDA recently announced that it will host a public workshop on August 6, 2024 focused on “Artificial Intelligence (AI) in Drug & Biological Product Development.” Aimed at bringing drug sponsors and AI experts together, the workshop, hosted in collaboration with
UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices
On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the “Statement”). The Statement follows the Government response to the
FTC 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
MHRA Outlines New Strategic Approach to Artificial Intelligence
On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”). The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and
EHDS Series – 5: European Health Data Space Governance, Enforcement and Timelines
In March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). Although the text has not yet been formally adopted by all the European institutions, a number of interesting points can already be highlighted. This article