The 21st Century Cures Act, which passed in the House of Representatives July 9, includes a non-binding amendment in favor of including unique medical device identifiers in electronic health records.
Unique device identifiers would identify the manufacturer and model of medical devices, such as implanted joints and heart valves.
The amendment, offered by Rep. Mike Fitzpatrick (R-Pa.), states that "[i]t is the sense of the Congress that recording unique device identifiers at the point-of-care in electronic health record systems could significantly enhance the availability of medical device data for postmarket surveillance purposes."
At least one organization, the Pew Charitable Trusts, has come out in support of the amendment.
"These codes ... are integral to building a robust postmarket surveillance system to improve device safety, track performance, locate recalled products, and improve care coordination among clinicians treating an individual," Pew said in a statement. "Pew--along with the U.S. Food and Drug Administration, large hospital systems, surgeons, patients and other key health care stakeholders--have all supported the inclusion of these identifiers in patients' health records. In addition to documenting identifiers in patients' records, improving device surveillance requires the addition of these codes to insurance claims, which would create a large database for analyses of product performance."
However, the Cures Act, which, among other things streamlines the development and evaluation of new drugs and devices, does not include consideration for creating unique patient identifiers to match patient records to the correct patient, despite requests that the House consider doing so. The College of Healthcare Information Management Executives, in a letter in May, warned that better patient identification is "the most significant challenge" to safe electronic information exchange and that the prohibition is "outdated."
Unique patient identifiers were required by the 1996 Health Insurance Portability and Accountability Act (HIPAA), but in 2000 Congress prohibited not only the identifier but also any testing of one. The current Omnibus bill bars HHS from using funds to provide unique patient identifiers "until legislation is enacted specifically approving the standard."