Certain health care providers, health information technology (IT) developers, and health plans could see the way they share patient information transformed following the release of two new final rules issued by the U.S. Department of Health and Human Services. The rules address interoperability and information blocking. Reed Smith partner Nancy Bonifant Halstead and senior associate Vicki Tankle provide an overview on key provisions of these rules in their post on our Health Industry Washington Watch …

As corporations continue to grapple with economic issues surrounding COVID-19, global life sciences companies must start to determine how laws in each of the jurisdictions in which they operate will impact their contractual responsibilities and opportunities for remedies in their business relationships. Life sciences companies with operations in France must recognize that their COVID-19 response will likely need to be different than their responses to previous crises, and not only because French law has significantly…

The Innovative Medicines Initiative (IMI) was created in 2008 as a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).[1] Its overall goal is to increase the competitiveness of R&D in the European pharmaceutical sector by encouraging companies to work with each other and with the public sector. Over the past decade, IMI has expanded its activities beyond the pharmaceutical sector and it also partners with medicine…

On January 30, 2020, the World Health Organization (WHO) declared novel coronavirus (also known as “2019-nCoV” and “SARS-CoV-2”) a Public Health Emergency of International Concern, and the United States Department of Health and Human Services (HHS) named it a public health emergency (PHE). In the United States, the declaration of a PHE empowers HHS to direct funding to: (1) allow the distribution of information about the virus; (2) encourage research and development of diagnostic and…

The Court of Justice of the European Union (CJEU) upheld decisions by the European Medicines Agency in two identical rulings on January 22, 2020. In the cases of PT Therapeutics International v. EMA (C-175/18 P) and MSD Animal Health Innovation and Intervet International v EMA (C-178/18 P), the decision was upheld to grant access to documents containing information submitted as part of medicinal product marketing authorisations (MA) applications. This decision could be of concern to…

On January 28, 2020, the Food and Drug Administration (FDA) announced that the Office of Prescription Drug Promotion (OPDP) will conduct two studies to examine how payment disclosure statements and the types of endorsers in drug advertisements affect consumers’ understanding of the information provided in the advertisements. Below is a summary of the studies. FDA invites comments on (1) whether studies like these are necessary for FDA to perform its duties, (2) the accuracy of…

Proposed amendment AB 713, if passed, would hopefully provide clarity to businesses working with clinical research data. The amendment proposes matching CCPA de-identification standards to those set forth in the Health Insurance Portability and Accountability Act (HIPAA), in addition to equally important clarifications for life sciences companies, health care providers and medical researchers. In particular, AB 713 covers five major principles: HIPAA De-identification Privacy Disclosure Business Associates Medical Research Product and Medical Device Tracking…