Devices & Diagnostics

HIMSS: 4 reasons why the FDA should ease up on EMR regulations

HIMSS put forward its take on why health IT products, particularly electronic medical records, shouldn’t be considered a medical device. The group published a letter this week in response to a query from the Department of Health and Human Services as the government hones health IT policy with an eye to patient safety. The move […]

HIMSS put forward its take on why health IT products, particularly electronic medical records, shouldn’t be considered a medical device. The group published a letter this week in response to a query from the Department of Health and Human Services as the government hones health IT policy with an eye to patient safety.

The move is part of the U.S. Food and Drug Administration’s safety and innovation act designed to develop recommendations on health IT regulation.

A letter penned by Scott MacLean, chairman of HIMSS and the deputy CIO at Partners Healthcare, and HIMSS CEO H. Stephen Lieber said:

“In our experience, innovative efforts can spur the development and adoption of health IT solutions that accelerate patient safety and support quality improvements. The challenge becomes finding the balance between regulating technology to support patient safety without stifling technology improvements and innovation intended to improve safety, quality, and cost-effectiveness.”

It acknowledged that interoperability between medical devices and electronic health records is blurring the lines between the two areas, but it believes “the new health IT framework can complement the existing medical device regulatory process.”

HIMSS represents hundreds of health IT companies. The group has these four recommendations:

  • Take a holistic approach: Any regulatory or oversight framework should recognize that health IT is part of a complex patient care ecosystem involving providers, product developers, vendors, a wide array of use cases, and consumers as patients and caregivers.
  • Shared responsibility: The safety and efficacy of health IT as it fits within the patient care system can be enhanced through non-punitive surveillance and reporting systems based on mutual trust and shared responsibility by all participants.
  • Clear oversight direction: Clear and consistent guidance regarding proposed regulatory and/or oversight activity is essential to ensure that health IT can continue to provide the innovation and tools necessary to achieve the patient safety and quality improvement goals, and cost efficiencies sought by all stakeholders.
  • Role of intended use/functionality: Regulation and oversight actions should be based on the intended purpose and intended user of a particular product or service.

Patient safety and HIT often show up in reports from the ECRI Institute. It has focused a lot of attention on the need for a thoughtful approach to rolling out EMR upgrades that involves all users as well as sufficient testing before launch. It has also called attention to problems caused by entering incorrect data or when data gets interpreted incorrectly from one end of the system to another. It highlighted some of these issues in its annual top 10 list of health technology hazards published this week.