Rapid advancement in life sciences technologies has made keeping up with the legal implications more important than ever. Join the Berkeley Center for Law and Technology for the 2nd BCLT Advanced Life Sciences Institute, where you will learn from the experts about cutting-edge issues impacting your life sciences practice.
The programming will share key
Taking a Closer Look at ONC’s AI Transparency Regulations
In recent years, organizations have been developing and using predictive models, which are powered by artificial intelligence (AI) and machine learning (ML) technologies, for numerous use cases in clinical and health care settings, including to aid in clinical decision-making. Currently, healthcare AI systems and tools have both clinical and administrative applications, namely monitoring patients,
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 subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12
Virtual and Digital Health Digest, April 2024
This digest covers key virtual and digital health regulatory and public policy developments during March.
You will note that the EU institutions have been busy during March. On March 12, 2024, the European Parliament (EP) formally adopted the revised Product Liability Directive, which makes several important changes to the existing European Union (EU) product
EHDS Series – 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices
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 focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS
Artificial Intelligence Highlights from FTC’s 2024 PrivacyCon
This is the second post in a two-part series on PrivacyCon’s key-takeaways for healthcare organizations. The first post focused on healthcare privacy issues.[1] This post focuses on insights and considerations relating to the use of Artificial Intelligence (“AI”) in healthcare. In the AI segment of the event, the Federal Trade Commission (“FTC”) covered: (1) privacy themes;
Senate HELP Committee Ranking Member Issues Health Data Privacy Policy Recommendations
On February 21, Senator Bill Cassidy (R-LA), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report to propose policy recommendations to revise the Health Insurance Portability and Accountability Act of 1996 (HIPAA) framework and ensure privacy protections for health data and information. In the report, Senator Cassidy highlights recent
Forecasting the Integration of AI into Health Care Compliance Programs
This post was co-authored by Josh Yoo, legal intern at Robinson+Cole. Josh is not admitted to practice law.
Health care entities maintain compliance programs in order to comply with the myriad, changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial intelligence (AI) are
Commission Communication on biotechnology and biomanufacturing
On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; and Questions & Answers on the Commission Communication.
The Communication, while directed towards the broader biotech sector, refers to the aim to
Healthcare Highlights from FTC’s 2024 PrivacyCon
Last month, the Federal Trade Commission (“FTC”) hosted its annual PrivacyCon event, featuring an array of experts discussing the latest in privacy and data security research. This post, covering healthcare privacy issues, is the first in a two-part series on PrivacyCon’s key takeaways for healthcare organizations. The second post will cover topics on artificial intelligence