The HHS Office of the National Coordinator for Health IT (ONC) recently released a contractor-developed “Health IT Safety Center Roadmap.” This policy document by RTI, International provides a vision of the possible future scope and responsibilities of the Health IT Safety Center.
The center was previously discussed in the Food and Drug Administration (FDA)-Federal Communications Commission (FCC)-ONC joint “Health IT Safety Plan” in 2014. The 2014 tri-agency plan was mandated by the FDA Safety and Innovation Act of 2012 (FDASIA) to delineate agencies’ jurisdiction on health IT safety. The plan categorized which functionality types would be actively regulated by FDA and which would be unregulated and/or subject to non-regulatory safety activities under ONC’s umbrella. Under that plan, the Health IT Safety Center would be a public/private partnership supported by ONC to enhance safety via exclusively non-regulatory/voluntary activities.
The recently released roadmap by RTI, International shares the same vision of the center as a decidedly non-regulatory convener of stakeholders and safety enhancement activities. It includes a startup organizational model (advisory board/executive director-led with its own staff) and funding source recommendations (an initial cooperative agreement with 5 years of ONC or AHRQ seed funding). It suggested that the full cost over five years could be $17.8-$20.6 million, with a sustainability plan kicking in thereafter to eliminate federal funding.
In essence, the center’s infrastructure would appear somewhat similar to the modern Patient Centered Outcomes Research Institute (PCORI), albeit with a different initial funding mechanism and totally different scope.
On July 3, the American College of Radiology (ACR) submitted comments to the Food and Drug Administration (FDA), Federal Communications Commission (FCC), and Office of the National Coordinator for HIT (ONC) regarding the agencies’ report on a proposed strategy for a risk-based regulatory framework for health IT. The agencies were mandated by a provision in the FDA Safety and Innovation Act of 2012 (FDASIA) to draft recommendations that appropriately balanced HIT safety with innovation and avoided overlapping jurisdictions.
The report called for a risk-based, three tier categorization scheme for HIT functionality. FDA would continue to regulate the highest risk “medical device” IT functionality as before, and would not expand into new areas of oversight. ONC, in collaboration with the private sector and a future public-private HIT Safety Center, would promote HIT safety through non-regulatory activities for the middle tier “health management” IT functionality. Functionality in the lowest risk “administrative” category (billing systems, etc.) would not be a safety concern.
The ACR participated in several federal efforts leading up to the proposed framework, including the FDA’s mobile medical applications guidance activities in previous years and a FDA-FCC-ONC meeting addressing the FDASIA HIT report in May 2014.
The Office of the National Coordinator for HIT (ONC) HIT Policy Committee (HITPC) convened for its 52nd monthly business meeting on September 4. The highlights of the meeting were presentations on the FDA Safety and Innovation Act Workgroup’s final draft recommendations and the progress of the Meaningful Use (MU) Workgroup’s efforts to develop recommendations on a “deeming” pathway for Stage 3 of the Medicare/Medicaid EHR Incentive Program.
The HITPC meeting was Dr. Farzad Mostashari’s last as National Coordinator for HIT. Dr. Mostashari did not provide any additional information about the transitional plans of the ONC.
On July 2, the HHS Office of the National Coordinator for HIT released its “HIT Patient Safety Action and Surveillance Plan” in follow-up to the Institute of Medicine’s 2011 report on “HIT and Patient Safety.” The plan explores ways to move forward on enhancing the safety of HIT, and using HIT to improve the safety of patient care.
On July 9, ONC published two papers in Health Affairs regarding EHR adoption (not meaningful use, per se) by physicians and hospitals. The physician paper relies on data from the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics’ “National Ambulatory Medical Care Survey – Electronic Health Records Survey,” which does not include data on EHR technology adoption by radiologists, anesthesiologists, or pathologists.
On July 9, during the ONC HIT Policy Committee’s 50th monthly meeting, ONC announced the departure of MacKenzie Robertson, FACA Program Director in the ONC’s Office of Policy and Planning. Ms. Robertson handled the primary ONC staffing responsibilities for the full HIT Policy Committee and HIT Standards Committee. She will be (temporarily) replaced by Michelle Nelson, ONC staff lead for the Meaningful Use Workgroup.
On May 30, the Food and Drug Administration Safety and Innovation Act (FDASIA) Workgroup—the newly formed advisory body jointly administered by the Food and Drug Administration, Office of the National Coordinator for HIT, and Federal Communications Commission—published a Request for Comments (RFC) on potential considerations for the development of recommendations on an appropriate, risk-based regulatory framework for HIT and mobile medical applications.
The FDASIA Workgroup is soliciting initial input on the following broad questions:
a. What types of health IT should be addressed by the report developed by FDA, ONC, and FCC?
2. Risk and Innovation
a. What are the risks to patient safety posed by health IT and what is the likelihood of these risks?
b. What factors or approaches could be included in a risk-based regulatory approach for health IT to promote innovation and protect patient safety?
a. Are there current areas of regulatory overlap among FDA, ONC, and/or FCC and if so, what are they? Please be specific if possible.
b. If there are areas of regulatory overlap, what, if any, actions should the agencies take to minimize this overlap? How can further duplication be avoided?
The ACR IT and Informatics Committee is currently reviewing the RFC. If any members of the American College of Radiology are interested in submitting feedback for potential inclusion in the ACR’s future comments, please contact me at firstname.lastname@example.org or 202-223-1670 ext. 4546.
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.
On October 11, the American College of Radiology’s (ACR) IT and Informatics Committee hosted the second annual “Imaging Informatics Summit” in Washington, DC. Radiologists, HIT thought leaders, industry, and federal government representatives participated in the event.
Dr. Jacob Reider (Acting CMO, Office of the National Coordinator for HIT) delivered the keynote presentation on the U.S. Department of Health and Human Services’ general approach to the Medicare/Medicaid EHR Incentive Program and the certification of EHR technology used in that program, as well as the role of imaging and radiologists. Dr. Keith Dreyer (Chair, ACR ITIC) discussed the program’s regulatory requirements and changes made in the September 2012 final rules. Dr. Alberto Goldszal (Robert Wood Johnson Medical School/UMDNJ) explored his practical meaningful use experiences in 2011 and 2012. I provided summit attendees with a very brief update about some of ACR’s interests and activities related to the program.
In addition to the EHR Incentive Program, this year’s summit featured a variety of pertinent HIT policy topics, including mHealth and mobile medical devices/applications, ACR Appropriateness Criteria-guided clinical decision support, and HIT-enabled radiation dose monitoring.