Premier Calls for Interoperability in ’21 Century Cures’ Measure
May 4, 2015 in News
The Premier health care alliance in a statement submitted last week to the House Energy and Commerce Subcommittee on Health urged lawmakers to require health IT interoperability in the newly released “21st Century Cures” draft bill, FierceHealthIT reports (Hall, FierceHealthIT, 5/1).
Last week, lawmakers on the House Energy and Commerce Committee released new draft legislation that would alter FDA’s oversight of health software products, but leaves out provisions on interoperability and telehealth.
Specifically, the latest draft bill, among other things, includes a revised SOFTWARE Act, which defines the types of health software that would not be subject to FDA oversight. In addition, the SOFTWARE Act outlines exceptions when the agency could determine if a product “poses a significant risk to patient safety” (iHealthBeat, 4/30).
In addition, the new draft includes language that eases reporting requirements for the Open Payments database by removing a requirement for drugmakers and medical device manufactures to report payments made to doctors for:
- Continuing medical education sessions;
- Medical journal reprints; or
However, the language for the reporting exemption appears in brackets in the new draft bill, which means that it likely has not been given a permanent spot in the measure, according to the Wall Street Journal‘s “Pharmalot” (Silverman, “Pharmalot,” Wall Street Journal, 5/1).
The package stated that proposals aimed at interoperability and expanding Medicare beneficiaries’ access to telehealth services will be released “shortly” (iHealthBeat, 4/30).
In its comments to the subcommittee, Premier recommended that the federal government adopt:
- Methods to ensure and measure compliance with standards;
- Standards to promote interoperability and innovation, such as unique patient identifiers, open application program interfaces and clinical data query language; and
- Transparent and public interoperability measures (FierceHealthIT, 5/1).
Details of Committee Hearing
On Thursday, the full committee met to discuss the draft bill with FDA and NIH officials, who largely supported the measure, Healthcare IT News reports.
Representing FDA, Janet Woodcock — director of the Center for Drug Evaluation and Research — and Jeff Shuren — director of the Centers for Devices and Radiological Health — said the agency supported a provision in the bill that would incorporate patient feedback regarding product risks and benefits in FDA’s decision-making process.
Meanwhile, Kathy Hudson — deputy director for science, outreach and policy at NIH — said, “All of us at NIH believe passionately in this mission, and are dedicated to the pursuit of knowledge and, ultimately, cures.” She added that with support from the House, “we can anticipate a bright future of accelerating discovery across NIH’s broad research landscape, from fundamental scientific inquiry to translational and clinical research.”
During the hearing, Health Subcommittee Chair Joe Pitts (R-Pa.) noted that some work remains to be done.
He said, “Work continues on several complicated, yet critical issues, including the regulation of diagnostic tests and telemedicine” (Monegain, Healthcare IT News, 5/1).