ONC is now accepting applications for membership in new FDA SIA Workgroup of the HITPC

ONC is now accepting applications for potential membership for the new FDASIA Workgroup of the HITPC until March 8, 2013 The Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup is charged with providing expert input on issues and concepts identified by the Food and Drug Administration (FDA), Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to in order to inform the development of a report on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication. FDASIA indicated that if a workgroup was formed, it should be geographically diverse and include representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant experience. If you are interested in being considered for membership on the workgroup, please register at ONC's Workgroup Application Database. The three agencies will review the applications received by March 8, 2013. Anticipated Focus Areas: Throughout the report's development, the three agencies expect to seek input from the HITPC through this workgroup on various topics associated with what constitutes a risk-based regulatory framework for health IT that can also promote innovation, protect patient safety and avoid regulatory duplication. The FDASIA Workgroup is expected to build on prior work such as the Institute of Medicine (IOM) report, Health IT and Patient Safety: Building Safer Systems for Better Care and ONC's Health IT Patient Safety Action and Surveillance Plan; FDA's mobile medical applications guidance and Medical Device Data Systems Rule; FCC's National Broadband plan and other relevant work. Specifically the three agencies will seek input on issues relevant to the report, which include: ·       Types of risk that may be posed by health IT that impact patient safety, the likelihood that these risks will be realized, and the impact of these considerations on a risk-based approach; ·       Factors or approaches that could be included in a risk-based regulatory approach for health IT to promote innovation and protect patient safety; and ·       Approaches to avoid duplicative or overlapping regulatory requirements. All FDASIA Workgroup meetings and documents discussed at such meetings will be publicly available and will offer opportunities for public comments. Background: Section 618 of the 2012 FDASIA charges the Secretary of Health and Human Services (the Secretary) (acting through the Commissioner of the Food and Drug Administration (i.e., FDA), in consultation with the National Coordinator for Health Information Technology (i.e., ONC) and the Chairman of the Federal Communications Commission (i.e., FCC) to publish a report by January 2014 that expresses "a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication."

IHE Week and FDA announces mHealth regulatory approach

Another IHE Week, this time preparing Trial Implementation Profiles. I'm on the hook for Reconciliation, and we have another couple dozen comments to go.  One of the surprising responses from commenters is that the profile should REQUIRE that external identifiers for problems, medications and allergies be preserved.  That is going to result in a quite a bit of new text (now I have to explain what changes the identity of an entry).  I'm pleased with this response.  We made it a strong recommendation, but not a requirement because I felt that many EHR vendors would not implement the profile if it were required.  Most systems would need to alter their basic tables to record the external identifier.  But experience with prior implementations indicates that this really is the best way to handle it, and I certainly agree with the sentiment.

I spent a good bit of time with IT Infrastructure on Monday discussing Cross Enterprise Document Workflow (pdf).  This profile is critical for Patient Care Coordination, even though it is coming out of IT Infrastructure.  Here's a brief pitch I'm giving on it tomorrow for another group:

• In Ambulatory Care, providers are desperate for Workflow Management to track referrals, orders, and manage quality of care.
• But their workflows are loosely coupled and ill-defined.
• These need to integrate with well defined, tightly coupled workflows in a departmental system (e.g., imaging).
• XDW uses industry workflow standards to describe Human Tasks that can be well integrated across both settings.

The replacement of CDA with Human Task as the standard to manage the tasks is more than appropriate, and @rjhorniii has done a great job leading the discussion, and getting me and one of my colleagues to agree on an approach.  You can expect some significant changes to the public comment version to come out of this meeting.

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While at the meeting, the FDA came out with a proposed regulatory approach for mHealth devices and applications.  I haven't had a change to do more than skim it once.  I'll look over it in greater detail later.  One of the tweople I follow expressed surprise at the exclusion of Mobile devices being used as an EHR.  His interpretation was that EHRs were not medical devices.  In case you are curious, they also excluded EHRs from the Medical Device Data System rule.  It's not that EHRs aren't medical devices.  It's that FDA carefully classifies things so that something doesn't fall into competing classifications.  They may be issuing separate guidance on EHR systems, so they exclude anything that can be viewed as an EHR from the other rules and guidelines.  That way, when the EHR rule comes out, it will be clear WHICH regulations and procedures apply.

Medical Device Regulation: An Overview from the FDA

I don't usually cover medical device related topics in this blog, but the recent MDDS final rule (pdf) from the FDA has potential impacts on Health IT solutions using separate  interface engines.  As interface enginers are commonly used with Health IT, and they  could under this rule be considered a Medical Device Data System, I thought this webinar might be of interest to my readers.


  -- Keith


The FDA is presenting on the Medical Device Regulation on an upcoming HIMSS Webinar (April 13^th). You will need to register for this event (free to HIMSS members).  Thanks!

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Medical Device Regulation: An Overview from the Food and Drug Administration

Date: 4/13/2011
4:00-5:00PM EDT

Cost: $0.00 for HIMSS members $79.00 for non-HIMSS members

Registration Information

Description:

Abstract: 

The Food and Drug Administrations (FDA)'s Center for Devices and Radiological Health (CDRH) has the responsibility for assuring safety and effectiveness of medical devices in the United States.  The CDRH oversees medical devices by classifying them based on risk along with a number of oversight tools to promote health and reduce risk of harm to patients.  On February 15, 2011, the FDA published its final rule to reclassify Medical Device Data Systems (MDDS).  A Medical Device Data System is a new category of medical device that acts as a conduit for communication of electronic data obtained from other medical devices.  Learn more about the new rule and its implications for your organization from two key representatives of the Center for Devices and Radiological Health.

Learning Objectives: 

• Explore the role of the Center for Devices and Radiological Health plays in the regulation of medical devices
• Gain an understanding of risk-based oversight
• Discuss the Final "Medical Device Data Systems" rule

Speakers:

• Anthony D. Watson, BS, MS, MBA, Director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration 
• Bakul Patel, MSEE, MBA, Policy Advisor, Officer of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration

Continuing Education:

This webinar has been approved for up to 1.0 continuing education (CE) hours for use in fulfilling the continuing education requirements of the Certified Professional in Healthcare Information & Management Systems (CPHIMS)

REGISTER AT: http://www.himss.org/asp/ContentRedirector.asp?ContentId=76857&cetID=200