Full article reprinted from "The Gray Sheet" - March 30, 2009
Find out how a working group within FDA's device center is trying to understand the distinction between electronic health record systems and medical devices - and where the two types of products might overlap.
Full article reprinted from "The Gray Sheet" - March 30, 2009
With $19 billion allotted in President Obama's stimulus plan to promote the adoption of electronic health record (EHR) systems, experts anticipate that use of the systems will increase. And as the technology develops, the systems and software are becoming increasingly sophisticated.
This has led some, including Case Western Reserve University law and bioethics professor Sharona Hoffman, to call for increased federal oversight of EHR systems.
"There has to be recognition that these need to be regulated," Hoffman said in an interview. "They are more than just a data entry product. If they fail, patient care fails."
While there is no hard and fast definition of an electronic health record system, the Institute of Medicine in 2003 identified some core functionalities: they display health information and data; facilitate the management of clinical results and medication orders; and may provide decision support through reminders and prompts. Central to EHR systems is electronic communication and connectivity.
Regulators are now questioning whether certain capabilities and functionalities of EHR systems and other health IT meet the broad legal definition of a medical device: an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar article, including a component part or accessory, used in the diagnosis, mitigation, treatment or cure of disease.
If so, EHR systems would fall within FDA's purview. The systems currently are subject only to certification requirements under the industry-based Certification Commission for Health Information Technology (CCHIT).
"It could be that only certain portions or functionalities of the software or systems fall under the device definition," CDRH spokeswoman Peper Long said.
Carving out what kinds of systems or software fit into the device center's domain is the top priority for the agency's EHR and health IT working group, chaired by Office of Device Evaluation Director Donna-Bea Tillman, with staff from all the device center offices.
"The group is trying to prepare the center as these issues related to EHRs expand into everyday reality so that any necessary safety and effectiveness evaluation, regulation or monitoring can occur as smoothly as possible," Long said.
FDA agrees there are potential benefits to adopting EHR systems - fewer medical errors, more timely and complete access to a patient's medical data, for example - but warns "those same benefits can easily become risks if the systems adopted aren't designed with an eye toward safety, privacy and connectivity."
The working group hopes to lay the groundwork for the agency to develop a risk-based, flexible approach that would accommodate different EHR systems and keep up as the technology evolves. The specter of FDA regulation, however, likely will meet resistance from EHR vendors.
EHR Vendors Push Back Against FDA Oversight
FDA took a first step toward enforcing regulation of a type of software involved in electronic record-keeping - medical device data systems (MDDS) - with a February 2008 proposed rule.
The agency has exercised enforcement discretion on MDDS, which comprise software that transfers, displays, reformats or stores data from a medical device without acting upon that device. The proposed rule would formally downclassify MDDS from Class III to Class I, the lowest-risk product category, but require MDDS makers to comply with quality system requirements and design controls (1"The Gray Sheet" June 16, 2008, p. 4).
The move has caused some anxiety in the health IT industry, including among EHR companies. In comments on the proposed rule, the Electronic Health Record Vendors Association, part of the Healthcare Information and Management Systems Society, argued that EHRs do not meet the definition of MDDS or a device of any kind.
"The unique role that EHRs play in helping manage the care delivery and related decision-support processes ... does not fit the current software medical device model," the association wrote last May. "In view of the nature and purpose of EHR technology, it is our belief that that regulation of EHR technology is outside the FDA's purview."
The group warns that FDA regulation may hinder federal efforts to increase EHR adoption.
FDA is still reviewing the proposed rule and preparing a response to stakeholder comments, and hopes to release something in the next few months, according CDRH's Anthony Watson.
Is FDA The Ideal Overseer?
Industry and others will be watching closely as FDA defines its position on EHRs and other health IT.
Case Western Reserve's Hoffman and Andy Podgurski, associate professor of electrical engineering and computer science, made their case for federal regulation of EHRs in a recent post on The Hastings Center's Bioethics Forum and in a longer article in the fall 2008 Harvard Journal of Law & Technology.
"The novel and significant risks generated by EHR systems cannot be ignored," they wrote in the Harvard article. "The growing capabilities of EHR systems require increasingly complex software, which heightens the danger of software failures that may harm patients."
According to Hoffman and Podgurski, the CCHIT certification program is inadequate to ensure the safety and efficacy of EHR systems. But while they recommend oversight "akin" to FDA, they do not think the agency is the best choice.
"If we're really trying to get everyone to use EHRs in the next five years, and we're going to have a flood of new products and a flood of information to keep track of, it seems it's not the best approach to use an agency that's already overburdened and overwhelmed," Hoffman said in an interview.
Oversight by the Centers for Medicare and Medicaid Services or by a new health IT agency would be preferable, she said.
- Jessica Bylander
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