Informed Consent – Webinar Recording/Transcript
Informed Consent: Human Subject Protection in the Digital Health Age
Digital technologies that collect personal healthcare information are a blessing for clinical trial specialists.
It’s helpful to have the medical info for research purposes, but you need a solid understanding of the latest FDA and federal regulations for informed consent and human subject protection.
Join CenterWatch and experts Michael Werner and Sara Klock for a presentation on how to comply with FDA and other federal regulation of digital technologies March 31.
Key presentation takeaways:
- Assess how digital technologies used to gather, analyze and report healthcare data for medical treatment purposes or to promote a healthy lifestyle can also be used for research purposes
- Familiarize yourself with the regulatory landscape to understand how digital technologies and the information they gather and use in research will be regulated
- Determine how to design clinical trials using digital technologies that comply with the 21st Century Cures Act and changes to the Common Rule
- Identify what activities can be undertaken to develop new digital technologies without triggering federal research regulations
- Find out how to develop informed consent forms when Institutional Review Board oversight is required, and other compliance questions
- Identify factors likely to determine whether and to what extent certain technologies are regulated as medical devices by FDA
In the era of digital information collection you need to know how to gather, analyze and report healthcare data that is obtained electronically.
Meet Your Presenters:
Michael Werner is a Washington, D.C., public policy and regulatory attorney and a co-leader of Holland & Knight's Healthcare & Life Sciences Team. Mr. Werner has almost three decades of healthcare law, lobbying, regulatory, and reimbursement experience in D.C. He focuses on issues affecting FDA-regulated entities, including medical device, biotechnology and pharmaceutical companies developing and manufacturing prescription and over-the-counter (OTC) drugs, biosimilars, cosmetics, dietary supplements, and digital-health technologies.
Sara Klock is a Washington, D.C., attorney and a member of Holland & Knight's Public Policy & Regulation Group. Ms. Klock focuses her practice on food, drug and device, life sciences, and political law. She advises life sciences clients on regulatory matters before federal and state agencies and law enforcement authorities, including the U.S. Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC), as well as the Food, Drug, and Cosmetic Act (FDCA) and the Controlled Substances Act (CSA).
Who Will Benefit
- M&A groups focusing investment in the medical device or health IT space
- Medical device companies
- Pharmaceutical and biotechnology companies
- Developers and marketers of digital technology related to disease, health, fitness or a healthy lifestyle
- Legal counsel, technology developers and investors
- Regulatory affairs/compliance professionals
- Medical professionals
- Quality professionals
- Clinical trials professionals
- Digital health professionals