The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data repositories and use of those repositories for secondary research. All stakeholders involved in federally funded research should be aware of the Final Rule’s changes and prepare to implement them.
What You Need to Know about Changes to the Common Rule
By Bernadette M. Broccolo, Chelsea M. Rutherford, Jennifer S. Geetter, Jiayan Chen and Lisa Mazur on February 10, 2017
Tags: common rule, creation of biospecimen, data repositories, DEPARTMENT OF HEALTH AND HUMAN SERVICES, Federal Policy for the Protection of Human Subjects, genomic and biospecimen research, HHS, identifiable biospecimens for secondary research, identifiable private information, use of repositories for secondary research
Bernadette M. BroccoloBernadette M. Broccolo has been counseling health industry organizations for more than 37 years on leading-edge health industry relationship formation and realignments. Her areas of concentration include privacy, technology contracting, corporate governance, human subject protection and federal taxation of exempt organizations. Bernadette speaks and writes frequently on emerging health care topics of importance to her clients and the industry. Read Bernadette Broccolo's full bio.
Chelsea M. RutherfordChelsea M. Rutherford focuses her practice on corporate, transactional and regulatory matters affecting a wide range of clients in the health care and life sciences industries. Read Chelsea M. Rutherford's full bio.
Jennifer S. GeetterJennifer S. Geetter advises global life sciences, health care and informatics clients on legal issues attendant to biomedical innovation, research compliance, financial relationship management, digital health practices, and global privacy and data security laws. Jennifer represents a broad range of clients. Read Jennifer Geetter's full bio.
Jiayan ChenJiayan Chen counsels clients on a range of regulatory and strategic issues that arise in the context of biomedical innovation and data sharing initiatives. She also has extensive experience advising life sciences companies and their collaborators on state and federal “Sunshine” and gift ban requirements. Read Jiayan Chen's full bio.
Lisa MazurLisa Mazur advises health care providers and technology companies on a variety of legal, regulatory and compliance matters with a particular focus on digital health topics, including telehealth, telemedicine, mobile health and consumer wellness. Lisa advises a variety of health care providers and technology companies involved in “digital health,” including assisting clients in developing and implementing telemedicine programs by advising on issues related to professional licensure, scope of practice, informed consent, prescribing and reimbursement. Lisa helps clients identify and understand the relevant legal issues, and develop and implement practical, forward-thinking solutions and strategies that meet the complex and still-evolving digital health regulatory landscape.Read Lisa's full bio here.
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