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.
On April 3, the Food and Drug Administration (FDA), Federal Communications Commission (FCC), and HHS Office of the National Coordinator for HIT (ONC) released their highly anticipated report to Congress on a proposed strategy for a risk-based framework for regulating health information technology, including mobile medical applications. The report, which was mandated by the FDA Safety and Innovation Act (FDASIA) of 2012, has been in development since the FDASIA Working Group approved its final recommendations to the tri-agencies in late 2013.
The report categorizes health IT functionality into three buckets: administrative (scheduling, billing, inventory, etc), health management (most CDS, CPOE, electronic access to results, etc.), and higher-risk medical device functionality (CAD, bedside monitor alarms, radiation treatment software, etc). The focus of FDA regulation will continue to be on the third category. Private sector and ONC-coordinated quality/safety/standards conformity management activities will generally focus on the second category. FDA is seeking public comment on categorizing HIT that straddles the line between the second and third categories, such as certain CDS and EHR functions.
Moving forward, the tri-agencies will solicit public comment on the report and convene a three-day public meeting. The tri-agencies will also report periodically to the ONC HIT Policy Committee regarding implementation efforts. Additionally, Memorandums of Understanding will need to be developed in the future when and where jurisdictions mesh.
On November 19, the House Energy and Commerce Health Subcommittee held a hearing on “Examining Federal Regulation of Mobile Medical Apps and Other Health Software.” Dr. Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health; Dr. J. Leonard Lichtenfeld, Deputy Chief Medical Officer, American Cancer Society; and assorted representatives of the health IT industry participated as witnesses.
The hearing was primarily focused on the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013 (HR 3303), a bill that would codify certain aspects of FDA’s guidance on mobile medical applications while adding restrictions on FDA’s regulatory authority over certain types of software. FDA’s concern is that the current version of the bill would remove the agency’s existing authority over diagnostic software such as electronic blood glucose meters, computer-aided detection (CAD), and more.
As of this writing, the SOFTWARE Act only has 7 cosponsors and no Senate counterpart.
On September 13, the American College of Radiology released the first iteration of the ACR Advocacy in Action E-News. The E-News will be released weekly, covering a wide variety of ACR advocacy activities.
The American College of Radiology’s (ACR) Government Relations and Economics Departments published the May 2013 issue of the ACR Advocacy Update. The ACR Advocacy Update is a monthly e-newsletter featuring contributions from ACR staff who work on federal and state legislative, regulatory, and coding/reimbursement policy issues.
To view previous issues of the ACR Advocacy Update, please visit the ACR website.
CMS Publishes Minor Corrections to Stage 2 MU Final Rule; October 2012 ACR Advocacy Update Now Available
On October 23, the Centers for Medicare and Medicaid Services published various corrections to the agency’s September 4 final rule to update the requirements of the Medicare/Medicaid EHR Incentive Program. The October revisions are grammatical/administrative in nature and are unlikely to have an impact on eligible professionals.
In other news, the American College of Radiology’s (ACR) Government Relations and Economics Departments published the October 2012 issue of the ACR Advocacy Update. The ACR Advocacy Update is a monthly e-newsletter featuring contributions from ACR staff who work on federal and state legislative, regulatory, and coding/reimbursement policy issues.
To view previous issues of the ACR Advocacy Update, please visit the ACR’s Advocacy website.
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.
The American College of Radiology’s (ACR) Government Relations and Economics Departments published the September 2012 issue of the ACR Advocacy Update. The ACR Advocacy Update is a monthly e-newsletter featuring contributions from ACR staff who work on federal and state legislative, regulatory, and coding/reimbursement policy issues.
To view previous issues of the ACR Advocacy Update, please visit the ACR Advocacy website.
Earlier today, President Barack Obama signed into law S. 3187, the Food and Drug Administration (FDA) Safety and Innovation Act. The primary purpose of the legislation is to renew and enhance the user-fee programs for drugs and medical devices.
Among many other things, the legislation requires the FDA, Office of the National Coordinator for HIT (ONC), and the Federal Communications Commission (FCC) to develop a report detailing 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” within 18 months of enactment. The legislation also authorizes the Secretary of HHS to establish a geographically diverse and balanced working group to inform the process.
An HHS press release about the legislation is now available.
Online registration for the first annual ACR Imaging Informatics Summit and Dose Monitoring Forum will soon close. To reserve your seat, please visit the registration page by Friday, October 28.
This year’s meeting will take place November 3-4 at the Washington Hilton, 1919 Connecticut Avenue, NW, Washington, DC. Additional information, including the agenda and speaker list, is available online.