Regulatory Working Group
Chairs
 |
|
Michael Robkin
Treasurer, Kaiser Permanente
Michael Robkin is the Principal Enterprise Architect in Care Delivery
for Kaiser Permanente Information Technology (KP-IT), the $1 billion
technology management arm of Kaiser Permanente and the Kaiser Foundation
Hospitals. In this role, Mike is responsible for the Kaiser's national
systems strategy for both Biomedical devices and Medical Imaging.
Mike has been with KP-IT for 7 years and has more than 20 years
systems, software, and architectural experience in a wide variety of
demanding high performance areas such as medical imaging, artificial
intelligence, flight simulation, computer generated imagery, and network
protocol standards.
|
|
|
Scott Thiel
Regulatory Affairs Program Manager
Roche Diagnostics
|
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
If you are interested in joining the Regulatory Working Group please
click here and follow the join group
link.
