U.S. reps have questions for ONC's DeSalvo

By Tom Sullivan
10:33 AM

Remember the old days of mailing someone a letter then anxiously waiting for a return, via post? Snail Mail.

Well, the means of delivery have changed but the practice still exists within the federal government, even if the senders and receivers are at times perhaps asynchronous.

Earlier this week, for instance, Karen DeSalvo, MD, sent an e-mail to ONC staffers detailing top brass’ plans to restructure the office, to “pivot” she wrote, for the “next chapter,” wherein much of the federal funding for ONC health IT implementation and interoperability initiatives would essentially dry up.

In return, DeSalvo on Tuesday received a letter from the Energy and Commerce committee demanding answers. Specifically, they want DeSalvo to address these four questions: 

  1. When the authorization for the Medicare and Medicaid Incentive program expires, under what statutory authority does ONC believe it is able to regulate health IT and electronic health records, particularly in (but not limited to) non-Meaningful Use areas?
  2. The FDA is provided with the authority to regulate medical devices by the Federal Food, Drug and Cosmetic Act. What similar authority does ONC point to, going forward, to participate in regulatory activities in coordination with the FDA and FCC?
  3. To what extent does ONC’s notice of proposed rulemaking on 2015 EHR certification represents a broader shift in focus from coordination and promoting efforts related to interoperability, privacy and security, and quality reporting criteria, to the regulation of data collection, functionality requirements, and other areas where market forces are more likely to promote innovation and efficiency?
  4. What role does ONC plan to play moving forward on issues including, but not limited to, health IT safety and EHR certification requirements? How will the recommendations of ONC’s Federal Advisory Committees guide these plans? Will ONC’s role be limited to the scope of these recommendations?

At the heart of those questions are ONC’s intentions to create a Health IT Safety Center to regulate software and other HIT products, the committee explained, and the fact that ONC’s “2014 budget suggests it will impose a new user fee on health IT vendors and developers to support ONC’s certification and standardization activities,” as well as whether or not ONC actually has the authroity to carry out its intentions. 

The letter is signed by committee chair Rep. Fred Upton (R-MI), vice chair Rep. Marsha Blackburn (R-MS), chairman of the subcommittee on health Rep. Joe Pitts (R-PA) and chairman of the subcommittee on communication and technology Rep. Greg Walden (R-OR).