Archive for March, 2013

FDA Safety and Innovation Act Workgroup Members to be Named Next Week

March 28, 2013 1 comment

The Office of the National Coordinator for HIT (ONC) revealed that the roster of the FDA Safety and Innovation Act (FDASIA) Workgroup will be announced late next week.  The workgroup’s first meeting is scheduled for April 9.  This announcement was made during the HIT Standards Committee’s virtual meeting on March 27.

The purpose of the new workgroup will be to advise ONC, FDA, and FCC during the agencies’ development of a report to Congress on an appropriate regulatory framework for HIT, particularly in the area of mobile medical applications.  The FDA Safety and Innovation Act of 2012 mandated this activity due to concern about FDA’s 2011 draft guidance on mobile medical apps, as well as potential jurisdictional overlap between the three regulatory agencies.

Interestingly, Dr. Paul Tang (HIT Policy Committee Chair) will chair the new workgroup even though it was not originally intended by Congress to fall under the ONC HIT Policy Committee.

Categories: EHR, FDA, IOM

House Energy and Commerce Committee Hearings on mHealth and HIT Innovation

March 19, 2013 Leave a comment

On March 19, the U.S. House of Representatives Energy and Commerce Committee held the first in a series of three planned hearings on HIT innovation.  The first hearing focused on the ongoing efforts to better define the Food and Drug Administration’s (FDA) role in regulating mobile medical applications.  The other two hearings (March 20 and 21) will focus more broadly on the benefits of HIT to patients and the Administration’s perspectives on HIT regulation.

As you may recall, in July 2011, the FDA published for public comment its draft guidance to clarify oversight issues related to mobile medical applications.  FDA’s efforts to finalize the draft guidance were eventually hamstrung by the discussions in Congress leading up to passage of the FDA Safety and Innovation Act of 2012.  FDA’s plans for regulating certain mobile medical applications will remain cloudy until the guidance is finalized and published.

Most committee members and witnesses participating in the hearing seemed to agree that the FDA should expeditiously finalize the draft guidance to address the lack of clarity.  Committee Republicans expressed concern about the potential application of the Affordable Care Act’s medical device excise tax to the mHealth domain.  Democrats on the committee urged Republicans to not use mHealth innovation as a political tool for attacking the medical device excise tax and healthcare reform law in general.

Categories: FDA

HHS Releases RFI on Advancing Interoperability and Health Information Exchange

March 7, 2013 3 comments

On March 7, the U.S. Department of Health and Human Services (HHS) published a Request for Information (RFI) on advancing interoperability and health information exchange (HIE).  The public comment period will close at 5:00 PM (Eastern) on April 22, 2013.  The American College of Radiology leadership and staff are currently reviewing the content.

The discussions and questions in the RFI relate to a wide variety of predominantly Medicare/Medicaid programs and initiatives.  If ACR members have any suggestions or feedback on the below ten questions from the RFI, please email me at

1. What changes in payment policy would have the most impact on the electronic exchange of health information, particularly among those organizations that are market competitors?

2. Which of the following programs are having the greatest impact on encouraging electronic health information exchange: Hospital readmission payment adjustments, value-based purchasing, bundled payments, ACOs, Medicare Advantage, Medicare and Medicaid EHR Incentive Programs (Meaningful Use), or medical/health homes? Are there any aspects of the design or implementation of these programs that are limiting their potential impact on encouraging care coordination and quality improvement across settings of care and among organizations that are market competitors?

3.To what extent do current CMS payment policies encourage or impede electronic information exchange across health care provider organizations, particularly those that may be market competitors? Furthermore, what CMS and ONC programs and policies would specifically address the cultural and economic disincentives for HIE that result in “data lock-in” or restricting consumer and provider choice in services and providers? Are there specific ways in which providers and vendors could be encouraged to send, receive, and integrate health information from other treating providers outside of their practice or system?

4. What CMS and ONC policies and programs would most impact post acute, long term care providers (institutional and HCBS) and behavioral health providers’ (for example, mental health and substance use disorders) exchange of health information, including electronic HIE, with other treating providers? How should these programs and policies be developed and/or implemented to maximize the impact on care coordination and quality improvement?

5. How could CMS and states use existing authorities to better support electronic and interoperable HIE among Medicare and Medicaid providers, including post acute, long-term care, and behavioral health providers?

6. How can CMS leverage regulatory requirements for acceptable quality in the operation of health care entities, such as conditions of participation for hospitals or requirements for SNFs, NFs, and home health to support and accelerate electronic, interoperable health information exchange? How could requirements for acceptable quality that involve health information exchange be phased in overtime? How might compliance with any such regulatory requirements be best assessed and enforced, especially since specialized HIT knowledge may be required to make such assessments?

7. How could the EHR Incentives Program advance provider directories that would support exchange of health information between Eligible Professionals participating in the program. For example, could the attestation process capture provider identifiers that could be accessed to enable exchange among participating EPs?

8. How can the new authorities under the Affordable Care Act for CMS test, evaluate, and scale innovative payment and service delivery models best accelerate standards-based electronic HIE across treating providers?

9. What CMS and ONC policies and programs would most impact patient access and use of their electronic health information in the management of their care and health? How should CMS and ONC develop, refine and/or implement policies and program to maximize beneficiary access to their health information and engagement in their care?

10. What specific HHS policy changes would significantly increase standards based electronic exchange of laboratory results?

Categories: EHR, meaningful use
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