Regulatory Working Group
Chairs
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Michael Robkin
Treasurer, Kaiser Permanente
Michael Robkin is the Principal Enterprise Architect in the Health IT
Strategy and Policy department for Kaiser Permanente IT, the $2.2 billion
technology management arm of the Kaiser Foundation Hospitals. Mike
represents KP as a founding member of the Board of Director of the
Continua Health Alliance. He is also Treasurer of Continua and co-chair
of the Regulatory Working Group.
Mike has more than 20 years of technical leadership experience in the
governance, management, research, architecture, and software development
for a wide variety of mission-critical domains including remote
monitoring, artificial intelligence, flight simulation, computer
generated imagery, and distributed databases. Mike worked for Hughes
Aircraft in California and General Motors in Germany before coming to KP.
At KP Mike has led the development of the National Systems Strategies and
Enterprise Architectures for Medical Imaging, Biomedical Devices,
Laboratory, and Pharmacy.
Currently his work is focused on interoperability and regulatory
issues for KP.
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Scott Thiel
Regulatory Affairs Program Manager
Roche Diagnostics
Scott
Thiel is a Regulatory Affairs Program Manager in Roche Diagnostics
Global Diabetes Care Regulatory Group. He joined Roche Diagnostics
in 1988 after receiving his BS in Biology and Chemistry from Ball
State University in 1987 and working as a Medical Technologist.
After joining Roche Diagnostics, Scott earned his MBA through
Indiana Wesleyan University in 1999. Scott has worked in various
functions within Roche during his nearly 20 years with the company,
ranging from lab work in product development to supervising a
quality lab to technical support and project management of
internationally launched diabetes care product lines. For the past
5+ years, he has worked within the regulatory affairs area
supporting the diabetes care product lines produced by Roche. He
achieved regulatory affairs certification (RAC) from the Regulatory
Affairs Professional Society (RAPS) in 2007. Scott sits on several
industry-related groups, including the Combination Product
Coalition, AdvaMed Software Working Group, and CLSI Area Committee
Point-of-Care. He is also an active participant in the Continua
Health Alliance, Regulatory Work Group serving as a co-chair.
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Regulatory Working Group Charter
Clarification and description of interoperable devices functions in a
regulatory environment.
- Scope includes both pre-market and post-market.
- Scope includes international regulatory bodies:
- FDA
- Health Ministry of Japan
- EU member states
- Health Canada
- Therapeutic Goods Administration (TGA Australia)
- And others
- Investigate official approaches to clarifying regulation of
interoperable devices (Could be 513(g). Could be form 3429. Could be a white
paper. Could be some other process yet to be determined.)
Educate and socialize the FDA and other regulatory bodies on Continua and
interoperable devices.
Education and helping each alliance company. Which could include:
- Testing and certification tools.
- Shared resources.
- Shared documentation and risk analysis.
Coordination with other Continua Working groups and providing input as
appropriate.
Join
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