House leaders on Wednesday unveiled an updated draft of the 21st Century Cures Act, which aims to "accelerate the discovery, development, and delivery cycle to get promising new treatments and cures to patients more quickly."
While the draft does not include language pertaining to telemedicine--which FierceHealthIT reported could happen--nor does it include language about the interoperability of electronic health records, it does include a new version of the Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) bill, which differentiates between health IT tools the U.S. Food and Drug Administration should and should not regulate. The draft did include placeholders for both telemedicine and interoperability language to be added later.
Bradley Merrill Thompson, an attorney with Epstein Becker Green who represents the CDS Coalition and other groups, called language in the new draft "difficult to interpret," and said he worries that it could create more uncertainty. For instance, regarding clinical decision support software, the new draft gives the FDA the power to determine whether specific categories of CDS could pose a risk to patient safety based on a variety of factors; language floated in January, however, declared that CDS would not be regulated as long as it allowed for "additional interpretation or an independent confirmation" of recommendations made.
"The original purpose of this legislation was to more clearly define the dividing line between regulated and unregulated software," Thompson said in an email to FierceHealthIT. "I would like to see the sponsors adopt language that more clearly differentiates regulated from unregulated CDS, rather than simply kicking the ball back to FDA."
Still, Thompson praised a change that eliminates the creation of a separate category of FDA regulated software to receive special treatment.
Mayo Clinic CEO John Noseworthy praised the 21st Century Cures package in a statement released by the Rochester, Minnesota-based facility, particularly the draft's emphasis on reducing regulations to speed the clinical trials process and efforts to increase funding for the National Institutes of Health. Noseworthy also made note of the fact that while telemedicine language was absent from this draft, he's hopeful it will be included in the final version of the legislation.
"While the discussion draft is the result of a diligent effort that took place over the past year to harness the best ideas from a broad range of stakeholders, we know more work lies ahead," Noseworthy said.
Health IT Now Coalition Executive Director Joel White also noted the absence of telemedicine, as well as interoperability, in the draft, calling both critically important details.
"The fact that interoperability and telemedicine were kept in the draft legislation confirms the committee's desire to find solutions for both issues, especially if given the time and resources to tackle the opportunity," White said in a statement.
Additionally, White applauded the SOFTWARE section of the bill.
"We believe this will spur development of new and innovative health IT products that will improve the treatments patients get while enhancing opportunities for them to engage in their care," he said.