Thank you to David Schoolcraft and the team at Ogden Murphy Wallace for shining some light on the new guidelines under the CURES Act and their impact on digital health innovation.
By dramatically reducing the barriers to data exchange, innovative digital health start-ups will be able to more easily deliver on their promise of impact.
Understanding regulations is a competitive advantage for digital health organizations. As you will see, David did a great job of highlighting key points! Some relevant references are highlighted below.
Our responsibility at Stride is to fully manage your back-office accounting and HR operations, so you can put your energy and investment in pushing forward to find product-market fit and scale. The opportunities discussed in this call are great examples of how you can gain traction through well-informed, focused execution.
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The ONC rule is clearly designed to support business practices that “promote the efficient access, exchange and use of EHI to support a competitive marketplace” that enhances value and choice. (See pg. 206)
Commentary goes on to call out incumbent vendors asserting they “must not interfere with a health care provider’s use of their acquired API technology in any way, especially ways that would impact its equitable access and use based on (for example) another software developer’s size, current client base, or business line.”
Broad Definition of Information Blocking
The information blocking provisions are extremely broad, as the rule provides that information blocking may come in many forms including but not limited to… “practices that limit the utility, efficacy, or value of EHI that is accessed, exchanged, or used, such as by diminishing the integrity, quality, completeness, or timeliness of the data”. (See pg. 356)
Dr. Rucker’s Comments
The pro-competitive concepts were reinforced by Dr. Rucker in an interview that he gave during HIMSS.
In particular, he said, “But there is no Uber or Lyft in healthcare. There’s nothing really like a robust banking application or an aggregator site for healthcare. And there just hasn’t been really entrepreneurial activity in this space because people haven’t had any access to the data. And what data has been accessed is very, very guarded, very proprietary and I think we’re gonna see new business models here.”