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
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Could FDA Model Master Files Facilitate Use of Third-Party AI Models in the Drug Life Cycle?
As the Covington team discussed in a recent article, use of AI models in biopharma is on the rise, with use cases spanning the life cycle of drugs and biologics, including product development, manufacturing, and pharmacovigilance. Recently, FDA announced
Quantum Computing and its Impact on the Life Science Industry
Quantum computing uses quantum mechanics principles to solve certain complex mathematical problems faster than classical computers. Whilst classical computers use binary “bits” to perform calculations, quantum computers use quantum bits (“qubits”). The value of a bit can only be zero
CMS & HHS Health IT Office Issue Request for Information on Digital Health Products and Health Technology Infrastructure
FDA Requests Comments on Substantial Proposed Changes to Data Standards
FDA has issued two Federal Register notices in under two weeks that seek comments on updates to FDA data standards.
European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers
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
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