Medical Devices

Public Workshop – Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology, May 13-15, 2014

The Food and Drug Administration (FDA), Office of the National Coordinator for Health Information Technology (ONC), and Federal Communication Commission (FCC) announced a public workshop entitled “Proposed Risk-Based Regulatory and Framework and Strategy for Health Information Technology.”

The FDA, ONC, and FCC sought broad input from stakeholders and experts. The topic discussed was the FDASIA health IT report that contained a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication.


Date, Time and Location:

This meeting was held May 13-15, 2014, beginning at 8:00 a.m. (EDT) at the following location:

National Institute of Standards and Technology (NIST)
Building 101, Red Auditorium
100 Bureau Drive
Gaithersburg, Maryland 20899-1070

NIST Campus Visitor Information

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Webcast

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Transcript

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Agenda

(NOTE: This agenda will be updated with additional details as they become available)

Tuesday, May 13, 2014
9:00 AM9:15 AMWelcome (kickoff/logistics), opening Remarks
9:15 AM9:30 AMOverview of Health IT report
Panel A
9:30 AM10:45 AMTopic 1: Risk-Based Framework
10:45 AM11:00 AMBreak
11:00 AM12:00 PMTopic 2: Categories of Health IT
12:00 PM12:30 PMPublic Comment A
12:30 PM1:30 PMlunch Break
Panel B
1:30 PM2:40 PMTopic 3: Promoting Quality Management
2:40 PM2:55 PMBreak
2:55 PM4:00 PMTopic 4: Best Practices
4:00 PM4:30 PMPublic Comment B
4:30 PM4:45 PMDay 1 Closing Remarks
 
Wednesday, May 14, 2014
9:00 AM9:15 AMDay 2 Kick-off, Opening Remarks
Panel C
9:15 AM10:30 AMTopic 5: Clinical Decision Support -  differentiating health management CDS functionality from  medical device CDS functionality
10:30 AM10:45 AMBreak
10:45 AM12:00 PMTopic 6: Clinical Decision Support - Tailoring the four priority areas for health management CDS
12:00 PM12:30 PMPublic Comment C
12:30 PM1:30 PMLunch Break
Panel D
1:30 PM2:40 PMTopic 7: Standards and Interoperability
2:40 PM2:55 PMBreak
2:55 PM4:00 PMTopic 8: Conformity Assessment
4:00 PM4:30 PMPublic Comment D
4:30 PM4:45 PMDay 2 Closing Remarks
 
Thursday, May 15, 2014
9:00 AM9:15 AMDay 3 Kick-off, Opening Remarks
Panel E
9:15 AM10:30 AMTopic 9: Environment of Learning & Continual Improvement – Reporting Safety Data
10:30 AM10:45 AMBreak
10:45 AM12:00 PMTopic 10: Environment of Learning & Continual Improvement – Analyzing Safety Data
12:00 PM12:30 PMPublic Comment E
12:30 PM1:30 PMLunch Break
Panel F
1:30 PM2:40 PMTopic 11: Health IT Safety Center – Value Proposition
2:40 PM2:55 PMBreak
2:55 PM4:00 PMTopic 12: Health IT Safety Center – Evidence/Education/Dissemination
4:00 PM4:30 PMPublic Comment F
4:30 PM4:45 PMWorkshop Closing Remarks

Public meeting format - Interactive panel style discussions – Panels will discuss topics along with interactive public/audience engagement (comment/questions)

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Registration to Attend the Workshop:

Registration is closed as of May 2, 2014. On-site registration is not available.

If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at susan.monahan@fda.hhs.gov at least 7 days in advance of the meeting.

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Contact Us

Contact for registration and logistics
If you require special accommodations due to a disability, or need additional information regarding registration, please contact:
Susan Monahan
Food and Drug Administration, Center for Devices and Radiological Health
10903 New Hampshire Avenue, Bldg. 66
Silver Spring, MD 20993
Tel: 301-796-5661
Email: susan.monahan@fda.hhs.gov

Contact for questions regarding public meeting topics
If you have questions regarding public meeting content or agenda topics:
Bakul Patel
Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue, Bldg. 66
Silver Spring, Maryland 20993
Tel: 301-796-5528
Email: Bakul.patel@fda.hhs.gov

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Page Last Updated: 07/17/2014
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