Webinar: Digital Health Technology and Human Subjects Research

Thursday, February 8, 2018 | 1:00-2:30 PM ET

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Overview

Advances in digital health applications, tools, and technologies are occurring rapidly and are here to stay. Often, these technologies are designed to be “disruptive” (i.e., to replace current technology or create a new market) and are developed by companies with strong computing and analytics capabilities, but lacking a strong foundation in health care norms. In addition, many of these technologies may not be subject to FDA oversight, and the developers might have focused less on the safety and effectiveness standards and benchmarks required for an FDA process.

IRBs cannot assume digital health tech is developed in compliance with the regulatory and ethical standards well-understood by human subjects protections professionals. In order to take advantage of these promising technologies, IRBs need to be equipped to assess the tool’s suitability to protect the data, privacy, and confidentiality of research subjects who participate in studies involving digital health technologies, and to recognize differences in the study designs and subject characteristics presented by digital health research.

When the appropriate measures are taken, the integration of digital health tools into existing processes and procedures holds the potential to improve some aspects of human subjects research, for example, informed consent and patient reported outcomes.

Through sharing of best practices and illustrative examples, the webinar presenters will discuss:

  • Differing priorities and goals among developers of digital health technologies and human research protections professionals
  • Strategies for IRBs and HRPPs to equip themselves to assess new digital health technologies
  • Ways to leverage digital health technologies to improve human subjects protections
  • Some promising technologies that are being used in studies that illustrate key considerations for IRB review

This is an advanced-level webinar. Attendees should have a prior understanding of the basic concepts, challenges, and opportunities that arise with digital health technology in research.

What will I learn?

After attending this webinar, you will be able to:

  • Identify and implement potential changes to policies, procedures, and practices in their HRPP in order to evaluate digital health-related technologies and research protocols
  • Develop institution-specific tools and guides for their IRBs to assess the sufficiency of the data protection mechanisms of digital health tools
  • Understand some of the ways in which digital health tools can support and improve human subjects protections

Who should attend?

IRB staff, IRB members, compliance personnel, institutional officials, researchers interested in using digital health technology, and research staff involved with (or who will be involved with) reviewing and conducting digital health research will benefit from attending this webinar.

Continuing Education

CIP Credit labelWebinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »

Speakers

Jeremy BlockJeremy Block, PhD, MPP is the managing partner of Venture Catalyst, working with investors and venture-backed companies to maximize the odds of venture success. Dr. Block is also an adjunct professor of public and international affairs at Baruch College. He is currently the executive director of a digital health trial focusing on population screening of genetic founder mutations at Memorial Sloan Kettering Cancer Center. Previously, Dr. Block was an assistant professor of population health science and policy at the Icahn School of Medicine at Mount Sinai where he was also an IRB chair. Dr. Block is primarily interested in the intersection of science and technology with society, public policy, and business. His background includes advising at the federal, state, and local level on a variety fields including; green procurement, human subject protections, chemical and biological weapons, emerging properties/markets with science and technology components, and research systems at universities. In addition, Dr. Block has developed technology in the areas of virtual reality and digital health. He has a background in teaching ethics in public policy, bioethics, and science/technology policy at both the undergraduate and graduate level. He holds a bachelor’s in chemistry and biology, master’s in public policy, and PhD in biochemistry from Duke University.

Jennifer GeetterJennifer S. Geetter, Esq. is a partner in the law firm of McDermott Will & Emery LLP. She focuses on emerging ethical and legal issues in connection with the life sciences, advising hospital, industry, insurance and provider clients on matters relating to research, drug and device development, off-label use, personalized medicine, privacy and security, electronic health records and data strategy initiatives, patient safety, conflicts of interest, scientific review and research misconduct, and emerging issues in future research concerning biological samples and data warehousing. Ms. Geetter also assists health care clients in implementing research strategies, structuring research operational and compliance infrastructure, and in developing guidelines for the appropriate relationships between providers and industry. She is a frequent speaker and author on these topics.

Additional Resources

A collection of relevant background reading, further reading, links, templates, checklists, and/or charts accompany each PRIM&R webinar. Groups that register for webinars receive a discussion guide containing thought-provoking questions and facilitation tips that may help in using the webinar as an educational tool for IRBs.

Background Reading:

Geetter, J.S., Gottlieb, D.F., Schmitz Mazur, L., Sealander, K.S., Weinstein, S.A. (2016). 21st century Cures: Health Information Technology and Digital Health Tool Provisions in Title IV. McDermitt, Will & Emery.

Thank You to our Webinar Supporter!

HRP Consulting Group

HRP Consulting LogoHRP Consulting Group provides expert advice to institutions seeking to develop or improve all aspects of their human research protection program. For more information, please visit www.thehrpconsultinggroup.com.

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Fees

If you are not yet a PRIM&R member, we encourage you to join today, and take advantage of your very first membership benefit immediately: a discounted registration fee to this webinar.

Individual rates
Member $145
Nonmember $200
Group rates
Member $325
Nonmember $400

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Please email Nora Murphy, online learning coordinator, at webinars@primr.org, if you have additional questions.