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AMIA Notes Health IT Safety Considerations to FDA in EHR Use

Using health IT to support quality improvement in primary care is an EHR use excluded from the definition of device in the Cures Act, the association explained.

ehr use health it safety

Source: Thinkstock

By Elizabeth Snell

- There are key considerations within EHR use related to health IT safety, AMIA explained in response to FDA’s request for input on health IT benefits and risks associated with the software functions excluded from the 21st Century Cures Act device definition.

FDA requested feedback on its approach to adhering to the Cures Act, specifically with regard to non-device software functions and assessing the impact that such software functions have on patient safety.

“The Cures Act amended the Federal Food, Drug, and Cosmetic Act to exclude certain medical software functions from the definition of a medical device,” FDA explained in a May 2018 blog post. “Under the Cures Act, Congress excluded specific types of software from FDA regulation, including general wellness software products, electronic patient records and more.”

FDA Commissioner Scott Gottlieb, MD said in a statement that the agency wants to ensure that “safe and effective advances can be made available to patients more efficiently.”

“In keeping with our mandate from Congress, we’re also committed to reporting on the impact of software functions that current law excludes from FDA regulation, such as general wellness software functions,” he stated. “Today’s effort is part of our work to obtain public input that will help shape our report to Congress about these software functions that we don’t regulate.”

AMIA noted several areas of research that highlighted potential benefits and risks to personal health and safety, including those in EHR use and the patient health record, as well as administrative support and clinical decision support.

For example, health IT improves care quality and patient outcomes in primary care settings.

“The effective use of health information technology (IT) by primary care practices to facilitate quality improvement (QI) can help practices improve their ability to deliver high quality care and improve patient outcomes,” AMIA said, citing an AHRQ white paper.

Subsequently, medication errors can also be attributed to health IT and EHR use.

“Drawing from 889 medication error reports submitted over a 6-month period, [Pennsylvania Patient Safety Advisory] analysis found that more than half of the recorded incidents were associated with computerized provider order entry,” the letter explained.

Software design, implementation decisions, user training, and maintenance processes can all have a great impact on health IT safety of health IT, AMIA said.

“A recent spate of highprofile ransomware attacks involving twelve hospitals’ EHR data has added a new dimension of concern for those focused on health IT safety: without access to digital information, clinicians are ‘flying blind,’ causing patients to be relocated and high-risk surgeries to be cancelled,” the association posited.

Understanding relevant research on the benefits and risks to health IT is especially critical as more providers and organizations continue to adopt new technologies, AMIA said.

Earlier this month, AMIA also stressed that health IT improvement be prioritized by CMS in its promoting interoperability (PI) program. Additionally, CMS should ensure PI helps in 2015 certified EHR technology (CEHRT) adoption among hospitals.

Proposed policies requiring the use of 2015 CEHRT by the start of 2019 as “foundational for improved interoperability, patient data access, and better usability,” are definitely a positive move, AMIA said.

“So too do we view the continuation of a 90-day reporting period for the Promoting Interoperability (PI) Program and the introduction of a new scoring methodology to the PI Program as critical policy changes that will enable hospitals to better work towards the goal of more efficient and seamless care coordination,” the letter explained.

PI proposed policies will also continue to ensure that health IT use and interoperability improve.

“Now is the time to think differently about how this program should evolve to meet the rapidly-changing, and often challenging, environment of care delivery,” AMIA Board Chair and Regenstrief institute President Peter J. Embi, MD stated.

“These new proposals position the program to build on progress made to-date, and our recommendations provide impetus for even more innovative changes focused on the ultimate goals of improving health and health care.”



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