Proposed legislation drafted by Sens. Orrin Hatch (R-Utah, pictured) and Michael Bennett (D-Colo.) looks to exempt electronic health records and clinical decision support software from oversight by the U.S. Food and Drug Administration.
The proposal--the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act--outlines five areas of the Federal Food, Drug, and Cosmetic Act, in all, to be amended. The bill's language says that the following should not be deemed "devices within the meaning" of the earlier law:
- Software intended for administrative or operational support of a healthcare facility
- Products unrelated to clinical treatment of a disease or disorder
- EHRs that "functionally represent a medical chart, including patient history records, but excluding diagnostic image data," as long as the EHR system is "validated prior to marketing"
- Software intended to format, organize or otherwise present clinical laboratory test report data prior to analysis
- Software for analyzing and supporting the display or printing of patient or other medical information for supporting or providing prevention, diagnostic or treatment recommendations to clinicians
When the bill will be formally introduced to Congress is unknown.
Epstein Becker Green health attorney Brad Thompson, who represents the CDS Coalition and the CDS Consortium, among others, told FierceHealthIT in an email that the legislation takes a "straightforward and clean approach to technology exemption," which he said is "less likely" to lead to unintended consequences.
"It very clearly carves out several categories of low-risk technology that should not be regulated," Thompson said.
In particular, Thompson was pleased with the Hatch and Bennett approach to decision support oversight.
"FDA would not regulate software if the user can see through the software to the original data and clinical intelligence and make the decision for themselves," Thompson said. "If the software is simply doing what software does best, which is retrieving data and doing calculations, but the user has all of the information at his or her fingertips, the decision-making of the user is really governed under the practice of medicine and is not something into which the FDA should intrude."
In July, Thompson told FierceHealthIT that heavy-handed CDS legislation could cause confusion in the healthcare industry.
"The challenge with legislation is two-fold," Thompson said in July. "Number one, it's getting the line right, meaning appropriately dividing high risk from low risk. The other aspect of legislation is to do so clearly, without ambiguities that we spend a lot of time afterward arguing about and trying to figure out. … The risk is that not only might software that deserves to be regulated find itself unregulated, but that we actually find ourselves in worse shape because we're now arguing about brand new concepts and new language and we have to restart the whole FDA process to interpret this new language."
To learn more:
- here's the proposed legislation (.pdf)