The Department of Justice’s (DOJ) Office of Legal Council (OLC) released an opinion in May 2019 addressing the Food and Drug Administration’s (FDA) jurisdiction over drugs used in capital punishment. A result of a request by the U.S. Attorney General’s
Life Sciences Legal Update
Analysis & commentary by Reed Smith on trends & developments in life sciences & health care law
Life Sciences Legal Update, published by Reed Smith LLP, focuses on legal developments affecting multinational and global life sciences companies. The blog covers topics such as regulatory guidance from agencies like the FDA, product recalls, patent law issues including AI inventorship, and compliance with evolving healthcare and pharmaceutical regulations. It also addresses litigation trends, industry-specific legislative changes, and risk management strategies relevant to drug and medical device manufacturers. The blog serves as a resource for legal professionals and industry stakeholders seeking updates on the intersection of law and life sciences business operations.
Latest from Life Sciences Legal Update - Page 7
Munich Regional Court Clarifies When Claims for Transfers of Patents Become Time-Barred
Germany is one of the most important patent litigation jurisdictions in Europe, making developments in its patent law very important to life sciences companies operating globally. In recent years, the number of cases regarding claims for the transfer of patents…
Five Key Takeaways from OCR’s Proposed Rule to Scale Back the Non-Discrimination Requirements Applicable to Health Care Entities
The Department of Health & Human Services (HHS) Office for Civil Rights (OCR) recently issued a proposed rule (Proposed Rule) that would significantly scale back the non-discrimination regulations applicable to health care entities under the authority of Section 1557 of…
OCR Clarifies Direct Liability of Business Associates Under HIPAA
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new fact sheet outlining and clarifying violations of HIPAA (Health Insurance Portability and Accountability Act of 1996) for which a business associate can be held…
CNIL Imposes Penalty to Optical Center; French Highest Administrative Court Reduces Amount
Life sciences companies doing business in France will be interested in the recent results of Optical Center’s appeal of a penalty assessed by the Commission nationale de l’informatique et des libertés, the French data protection authority, surrounding a data breach.…
Health Apps and HIPAA – Recent FAQs Highlight Importance of Covered Entities and Business Associates Scrutinizing their Relationships with App Developers
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new set of HIPAA FAQs addressing the applicability of HIPAA to certain health apps and the covered entities and business associates that interact with them.…
HHS Reconsiders Penalty Structure for HIPAA Violations, Imposes Annual Limits based on “Level of Culpability”
On Friday, April 26, 2019, the U.S. Department of Health and Human Services (“HHS”) filed a Notice of Enforcement Decision (the “Notice of Enforcement”), confirming the agency’s reconsideration of its prior interpretation of the Health Information Technology for Economic and…
FDA Announces Public Hearing on Regulation of Cannabis and Cannabis-Derived Products
The Food and Drug Administration (FDA) will hold a public hearing on May 31, 2019, “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”1 This offers…
FDA Issues 2019 Goals to Improve The Quality of Compounded Drugs
Just prior to departing the FDA (U.S. Food and Drug Administration) Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram issued a statement (the “Statement”) on the Agency’s 2019 goals to improve the quality of compounded drugs. While the change…
Supreme Court hearing oral argument on agency-deference question
The Supreme Court of the United States heard oral argument on March 27, 2019 concerning a case (Kisor v. Wilkie, No. 18-15) involving the Department of Veteran Affairs (VA). The case asks the Supreme Court to consider overruling the current…