HHS Pushes Industry Forward with New Interoperability Rules

| Brittany McCullough
doctors holding tablet with medical overlay

By now I’m sure you all know that ONC and CMS both issued proposed rules to advance interoperability and health information technology (HIT) as mandated under the 21st Century Cures Act (Cures Act). There has been so much feedback on these regulations that the federal agencies both opted to extend their public comment period by 30 days at the request of stakeholders. 

The ONC proposed rule includes a number of proposed updates to the 2015 edition certification criteria and conditions and maintenance of certification. The draft rule also outlines seven proposed exceptions to information blocking. There are also a few requests for information, including a voluntary certification of HIT for pediatric settings and how to leverage HIT in prevention and treatment of opioid use disorder.

While there a number of provisions that have the potential to accelerate greater interoperability, I want to call attention to the proposed exceptions to information blocking. In my opinion, information blocking is arguably the greatest threat to interoperability. As defined in the Cures Act, information blocking is a “practice that except as required by law or specified by the Secretary…is likely to interfere with, prevent, or materially discourage access, exchange, or use of EHI”.

ONC’s seven proposed exceptions to information blocking are:

  1. Preventing Harm
  2. Promoting the Privacy of Electronic Health Information (EHI)
  3. Promoting the Security of EHI
  4. Recovering Costs Reasonably Incurred
  5. Responding to Requests that are Infeasible
  6. Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms
  7. Maintaining and Improving HIT Performance

While ensuring bad actors aren’t intentionally preventing the sharing of EHI when it is appropriate and necessary, there are times when sharing of EHI may not be appropriate. As written, healthcare providers, HIT developers, health information exchanges, and health information networks would have the opportunity to demonstrate the applicability of certain exceptions to their practice. For instance, under the “recovering costs reasonably incurred” exception, entities would be allowed to charge a fee for access to EHI based on the costs they reasonably incurred to develop the technology to enhance interoperability without being in violation of the information blocking provision.

While I’m generally supportive of most of the provisions to enhance patients, their designees, and providers’ access to EHI, there is legitimate concern regarding the level of effort that will be required to enact these changes as they will likely dramatically reshape the healthcare system as we know it.

When I asked Margaret “Maggie” Cornett, RN, MS, CHCIO, URAC’s Chief Information Officer, about her thoughts on the proposal, she stated that “the basis for interoperability is patient matching and I fear that more focus is required in this area for interoperability to be truly effective.” She continued by stating, “there will be significant administrative burden to achieve what is proposed, not only on the major electronic health records (EHR) vendors, but on the hospitals and health systems implementing data exchange.”

The concern around the fast implementation was also echoed by Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) during a recent hearing. Chairman Alexander indicated that he was worried the rushed implementation could lead to data privacy issues and encouraged HHS to gradually implement the proposals.

In our comments to ONC, URAC echoed these concerns while also lending support to ONC’s work to increase access to and the exchange of EHI so that patients can make informed healthcare decisions.

To read URAC’s comments click here.

Brittany McCullough photo

Brittany McCullough, Manager, Health Policy and Government Programs.

Brittany McCullough, URAC's Manager of Health Policy and Government Programs, tracks and analyzes legislation and regulations of importance to URAC stakeholders. She also helps manage URAC’s public policy external affairs portfolio and oversees compliance with government deemed programs. Most of her policy and research work has been related to the ACA, Medicaid managed care, Part D, telehealth and mental health parity. She holds a B.S. in Neuroscience and a Master of Health Administration.

Views, thoughts and opinions expressed in my articles belong solely to me, and not necessarily to my employer.

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