ONC’s Response Regarding Health IT Safety Center Called Inadequate
Key Takeaway: Rep. Marsha Blackburn (R-TN) expressed disappointment with the Office of the National Coordinator for Health IT’s (ONC) response during a House Energy and Commerce Committee hearing last week regarding its authority to establish a Health IT Safety Center.
Why it Matters: Members of Congress are accusing ONC of expanding its regulatory role and could potentially force it to abandon its efforts to create a health IT Safety Center if ONC doesn’t provide sufficient evidence of its authority to create the center as proposed in the draft FDASIA Report, a risk-based regulatory framework for health IT created by the Food and Drug Administration (FDA), ONC, and Federal Communications Commission (FCC).
ONC submitted a response (http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/letters/20140708ONCresponse.pdf) on July 8 outlining its defense for the creation of the Health IT Safety Center. The letter states that “The [FDASIA] report did not propose that the Health IT Safety Center would have the authority to regulate health IT,” but it would facilitate the creation of a health IT learning system. The letter explains that stakeholders from the public and private sectors could work together to prevent regulatory duplication and find ways to leverage existing initiatives. ONC also defended its statutory authority by stating that under HITECH (Health Information Technology for Economic and Clinical Health), ONC is charged with performing “a broad range of duties ‘in a manner consistent with the development of a nationwide health information technology infrastructure’ that, among other things, protects and promotes patient safety.” Thus, it believes that the Health IT Safety Center is within its purview.
Rep. Blackburn is a main author of the proposed SOFTWARE Act, a bill that would limit FDA’s regulatory authority; this demonstrates that she is not afraid to introduce legislation that limits agencies’ regulatory authority. CHIME plans to follow this ongoing dialogue between the House Energy and Commerce Committee and ONC. Meanwhile, the FDASIA report comment period closed on July 7, and the final report can be expected this Fall.
ECRI, RAND Study: Physicians Unaware of Health IT-Related Safety Issues
Key Takeaway: A recent ONC blog revealed that limited resources and competing priorities are contributing to low physician awareness of patient safety issues related to health IT.
Why it Matters: The study exposes the need for more education and staff resources for providers so they can better understand the risks related to health IT use.
The ONC blog (http://www.healthit.gov/buzz-blog/electronic-health-and-medical-records/...) discusses findings in the following areas:
- Alignment with other initiatives
- Organizational leadership
- Challenges in identifying health IT safety risks
- Challenges in matching project scope and resources to the demands of the health IT safety project
- Practical tools to identify and address health IT safety risk
The blog points out that the SAFER Guides discuss EHR risks and some “recommended practices,” however, the Rand Corporation and ECRI Institute study (http://www.healthit.gov/sites/default/files/rr654_final_report_5-27-14.pdf) states that the SAFER Guides “may not be used to their full potential” if providers aren’t aware of health IT risks. The report also suggests the government create tools that identify risks and methods to address them.
Legislation & Politics
Joint Subcommittee Hearing Looks to Update Health Technology Policy
Key Takeaway: The Energy and Commerce Subcommittee on Communications and Technology and the Subcommittee on Health held a joint hearing on Technology for 21st Century Cures to solicit suggestions for a healthcare transformation bill to be drafted by December and voted on in the next session.
Why It Matters: The Energy and Commerce committee has not set limitations for the bill it hopes to draft this year. Its bill could cover FDA regulation of mobile devices and approval of medications, electronic health records and information exchange, broadband initiatives, biomedical treatments, healthcare research, and other healthcare transformation initiatives.
Chairman Upton (R-MI) and Rep. Diana DeGette (D-CO) launched the 21st Century Cures (http://energycommerce.house.gov/cures) initiative in early May to focus on discovery, development and delivery of innovative healthcare solutions. They are “committed to making sure our legal and regulatory framework fosters the development of such a digital health care ecosystem and allows it to serve as a catalyst for the discovery, development, and delivery of new treatments and cures for patients.”
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