ANN ARBOR, MI, July 8, 2014 - The government's proposed, risk-based approach to regulating healthcare IT provides federal regulators an opportunity to adapt its health information technology certification program to focus on the dual goals of improving patient safety and interoperability, the nation's senior executive and physician health IT leaders said in recent public comments.
Responding to the tri-agency "FDASIA Health IT Report ," the College of Healthcare Information Management Executives (CHIME) and the Association of Medical Directors of Information Systems (AMDIS) filed joint comments yesterday, supporting most of the federal government's strategies to improve patient safety through health IT and develop an environment of continuous learning. The healthcare IT leaders said the biggest gains to patient safety could be obtained by re-tooling ONC's Certification Program to require more rigorous interoperability testing.
Developing a comprehensive framework to regulating healthcare IT gives the government "a unique opportunity to address some key challenges," CHIME and AMDIS said. "ONC should reconsider the role and composition of its certification program to address patient safety risks and interoperability."
The health IT report was issued in a draft version in early May by the Food & Drug Administration, the Office of the National Coordinator for Health IT and the Federal Communications Commission and posed several questions to industry stakeholders. CHIME's and AMDIS' comments were in response to the request for comments.
The current approach to certification has been too closely tied to arbitrary deadlines related to the EHR Incentives Program. "This has led to a market dynamic that incentivizes data silos, vendor lock-in and rewards developers who are first to certify, rather than a market characterized by usable, safe and mature health IT products," the comments noted.
CHIME and AMDIS recommended that ONC retool the certification program to focus on beta-testing, post-certified performance and standard adherence in live settings.
"Designing a certification program that more closely resembles the software development lifecycle would have a tremendously positive impact on both interoperability and patient safety," said Russell Branzell, president and CEO of CHIME. "The single biggest action federal regulators could take to improve patient safety is to identify clear standards and require strict adherence to those standards. We think certification is the lever and now is the time to reevaluate what is working and what is not."
"By relying heavily on existing policies and programs, we believe federal regulators have articulated a sound strategy to help the private and non-profit sector establish a learning health system, characterized by continuous improvement and consistent accountability," said Randy McCleese, CHIME board chair, and vice president and CIO at St. Claire Regional Medical Center, Morehead, Ky. "The industry has made great strides towards improving patient safety, and we must continue this trend by leveraging innovative technology, supported by consistent standards and best practices."
In other recommendations on the FDASIA Health IT report, CHIME and AMDIS recommended that federal officials:
- Engage with private-sector testing bodies who are developing tools to more consistently test and continuously monitor adherence to standards;
- Identify and incorporate key interoperability tests that have implications for patient safety, especially those related to transitions of care and the management of chronic care;
- Develop, as part of certification, a mechanism to monitor post-market use of health IT in live settings;
- Form a public-private partnership to develop an adaptable process for identifying standards and best practices, especially related to local implementation, customization and maintenance of health IT;
- Understand that different stakeholders have varying degrees of influence on the safety of health IT and should be expected to conform to different levels of rigorous assessments;
- Ensure that providers have an open pathway to report technology failures with implications for patient safety before such failures inflict patient harm; and
- Work to bolster a national network of patient safety organizations to help achieve a continuous learning environment.
The full text of the CHIME/AMDIS comments can be found on the CHIME web site or are available upon request.
The College of Healthcare Information Management Executives (CHIME) is an executive organization dedicated to serving chief information officers and other senior healthcare IT leaders. With more than 1,400 CIO members and more than 100 healthcare IT vendors and professional services firms, CHIME provides a highly interactive, trusted environment enabling senior professional and industry leaders to collaborate; exchange best practices; address professional development needs; and advocate the effective use of information management to improve the health and healthcare in the communities they serve. For more information, please visit www.cio-chime.org
Founded in 1997, the Association of Medical Directors of Information Systems is the premier professional organization for physicians interested in and responsible for healthcare information technology. AMDIS has more than 2,800 physician members worldwide, 250 associate members and 40 provider organization members. AMDIS members are the thought leaders, decision makers and opinion influencers dedicated to advancing the field of Applied Medical Informatics and thereby improving the practice of medicine. For more information, visit www.AMDIS.org .
Senior Director of Communications, CHIME