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 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
FDA has issued two Federal Register notices in under two weeks that seek comments on updates to FDA data standards.
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
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.
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
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
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 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
