Forbes: ONC rule and Healthcare Innovatin
December 02, 2020

How Much Impact Can A Small Federal Agency Have On Healthcare?

In 2008, Malcolm Gladwell’s book ‘Outliers’ hit the shelves and made famous the rule that “10,000 hours is the magic number of greatness.” Putting aside the accuracy or broad applicability of the rule, when 10,000 hours of invested time are paired with significant broader technological, cultural or economic shifts, there is opportunity for dramatic progress.

In healthcare, we may be at the cusp of such a time. Over the past decade there has been a wave of entrepreneurs and technologists who started their careers in health technology; now, smart federal policy is set to unleash the collective creative power of these entrepreneurs, to the benefit of patients, doctors and other clinicians, and our healthcare system as a whole.

The Affordable Care Act (ACA) and its impending demise, rebirth or replacement garnered most of the healthcare policy headlines during the past election year. And for those in the healthcare industry, there has been intense interest in the ongoing effort to shift from a fee-for-service payment model to a value-based payment system. But it’s a final rule from a small, little known federal agency that may have the most profound and positive impact in the short to intermediate term on the nature of our healthcare system.

A Final Rule With Big Implications

Mandates under the final rule include the following provisions for providers and their technology systems:

  1. Providers must provide electronic access to people to their health records at no cost
  2. Provider IT systems must “open up” and make data available to other health IT system requests through standard application programming interfaces (API)
  3. Provider IT systems must not use other contractual attempts attempt to block the flow of information between and amongst other technology systems

While people have had a right of access to their healthcare data (for a nominal fee) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), a combination of lack of consumer awareness, low value paper records, and provider bureaucratic processes have inhibited access on a broad scale.

Under the ONC’s new rule, doctors must give patients access to their health data from electronic medical records (EMRs), free of charge. This includes information like provider consultation notes, patient discharge summaries and procedure notes, as well as labs, pathology and imaging narratives.

Challenges and Lessons Learned: Remember Meaningful Use? 

The genesis of this new regulatory regime stems from an attempt to correct policy efforts and industry failure that drove provider adoption of electronic health records (EHRs) but failed in the “meaningful use” of that technology.

Included in The American Reinvestment & Recovery Act of 2009 (ARRA), the Health Information Technology for Economic and Clinical Health (HITECH) Act allocated $35 billion in funding for providers to both adopt and ‘meaningfully use’ EHRs. Hospital and physician adoption increased substantially during the early years of the program and now 90% of records are electronic.

Despite the high levels of EHR adoption, however, the promised benefits have failed to materialize. Why? Two primary reasons: first, the EHRs are generally not interoperable with each other (a provider using one EHR cannot easily share records with a provider using a different EHR); and second, providers lack business incentives to share records with each other or to invest in more interoperable systems.

“The industry has been keeping data behind walls, and not sharing sufficiently to really improve care,” says Paul Uhrig, Chief Administrative and Business Officer for The Commons Project. The Commons Project is a nonprofit public trust established to build digital platforms and services that improve care and quality of life on a global scale. One of these efforts is CommonHealth, a smartphone application for people with Android phones that allows them to easily collect, store and share their health data with organizations and digital health applications they trust.

Matthew Michela, CEO of Life Image, shares similar sentiments. “There were structural barriers to the flow of information in healthcare, and these contributed to quality problems and increased costs,” says Michela. Life Image is a medical image exchange platform that enables interoperability of images (think CT scans) across healthcare networks, providers, patients and technology systems.

But unlike other industries, technology is still very much in its growth and development phase in healthcare. “Technology generally becomes commoditized over time, and costs come down. But in healthcare that hasn’t happened yet,” says Michela.

“Access to information fuels innovation,” says Michela.

Many healthcare organizations have yet to think seriously about the importance of interoperability and may not even be aware of what information blocking is, Uhrig says, which increases the likelihood that this new ONC rulemaking will be highly disruptive for stakeholders throughout the industry.

Reducing The Barriers To Innovations For Improved Data Exchange and Accessibility

Fortunately, we’ve come a long way as an industry since 2009, with a better understanding of what’s required to make broad patient data sharing possible. And there’s been no shortage of interest or investment in the space, either, where a total of $40B in private capital has poured into platform technology companies like Livongo, GoodRx, Teladoc, Amwell over the past 10 years, all of which are starting to deliver strong returns.

The healthcare system, now almost fully digitized, is attracting entrepreneurs and venture capital seeking to find ways to improve access, decrease costs, and improve the quality of care. The problem to date? Entrenched interests and business models on behalf of both providers and incumbent EHRs continue to create barriers to innovation: digital health startups cannot get access to data; patients cannot get access to data; and providers can’t easily share data. In fact, seamless information exchange between providers is still a rarity today, despite the fact that the majority use an EHR.

This is what makes the information blocking statute and rules such a timely, necessary piece of the health IT policy framework moving forward. With the rules, enforcement and compliance efforts in place, digital health innovators will for the first time have access to the data they need to innovate without exorbitant or unreasonable transaction costs.

Unleashing The Potential For Digital Health 

The promise that access to data holds isn’t just theoretical. Michela of Life Image sees the ways that barriers to access to clinical data is holding back innovation today. Referring to innovative artificial intelligence solutions in radiology, Michela explains, “There’s a lot of really great AI solutions that get FDA approval, but get no adoption. They can’t get adoption because the information infrastructure is not standardized and the incumbents have no incentive to open up access to their data.”

Incumbent organizations have massive leverage over their customers and have no incentive to open up access to their data, said Michela. “When you standardize the data and exchange, barriers to entry come down, which spurs innovation,” he said, adding that the information blocking legislation and subsequent regulatory process has recognized the importance of a level playing field to free up the health tech industry to innovate.

And Michela is bullish on the opportunities that the Information Blocking rule creates for digital health platforms. “Platforms like Life Image will continue to play an important role. In order to make data meaningful, we need platforms to standardize data further, turn it into discrete data elements, and importantly, make it query-able, or provide a single source where folks can turn to request data,” Michela explains.

Easier, faster and greater access to data will empower people, agrees Uhrig, which is precisely what he’s betting on with CommonHealth. “By providing tools for people to securely access, store and share their health information with digital health applications they trust, we’ll help unleash an ecosystem of innovation.”

Reaching Or Already at 10,000 Hours 

Entrepreneurs just starting out (or venture capitalists with capital to deploy), needn’t worry about missing the boat on the opportunities that the Information Blocking rules will create. In fact, the current Rule should be viewed as a starting point, not an end point.

For instance, both Michela and Uhrig raise questions over whether the list of actors covered by the Information Blocking Rule should be expanded to include other covered entities as well as additional types of technologies. And while the Rule prohibits EHR incumbents from engaging in business and contractual practices that in reality are anti-competitive (and thus inhibit innovation), the technical aspects of what EHRs will be required to do to comply is limited to start; for example, the core data set that EHRs must make available via established standards does not include the types of images that Life Image deals with.

Information Blocking also doesn’t directly address other challenges that have prevented interoperability efforts, including issues related to patient matching or creating a “trust fabric” that can facilitate faster and more open information sharing.

But for an industry notorious for the type of entrenched interests and bureaucratic decision-making that has slowed innovation, the door has just been cracked open. Information is about to start flowing in a much freer manner, which, outside of creating immense opportunities for entrepreneurs and investors, should benefit patients most of all.

Disclosure: the author’s consultancy works with The Commons Project.

By Seth Joseph. Originally published by Forbes on December 2, 2020


Read more about the Final Rule here.