By DAVE LEVIN MD
The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have published proposed final rules on interoperability and data blocking as part of implementing the 21st Century Cures act. In this series we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex, controversial topics, and open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions.
Health IT 1.0, the basic digitalization of health care, succeeded in getting health care to stop using pens and start using keyboards. Now, Health IT 2.0 is emerging and will build on this foundation by providing better, more diverse applications. Health care is following the example set by the rest of the modern digital economy and starting to leverage existing monolithic applications like electronic health records (EHRs) to create platforms that support a robust application ecosystem. Think “App Store” for healthcare and you can see where we are headed.
This is why interoperability and data blocking are two of the biggest issues in health IT today. Interoperability – the ability of applications to connect to the health IT ecosystem, exchange data and collaborate – is a key driver of the pace and breadth of innovation. Free flowing, rich clinical data sets are essential to building powerful, user-friendly applications. Making it easy to install or switch applications reduces the cost of deployment and fosters healthy competition. Conversely, when data exchange is restricted (data blocking) or integration is difficult, innovation is stifled.
Given the importance of health IT in enabling the larger transformation of our health system, the stakes could hardly be higher. Congress recognized this when it passed the 21st Century Cures Act in 2016. Title IV of the act contains specific provisions designed to “advance interoperability and support the access, exchange, and use of electronic health information; and address occurrences of information blocking”. In February 2019, ONC and CMS simultaneously published proposed rules to implement these provisions.
The simultaneous announcement reflects the coordinated effort between CMS and ONC to make the most of their respective regulatory powers. ONC is acting to set the basic requirements for certification and use of health IT while CMS is tying the proper use of certified health IT to conditions of participation. Put simply, ONC is defining how health IT companies, providers and others should behave, and CMS is tying compliance with those behaviors to payment for services. This powerful set of carrots and sticks have proven quite effective in the past.
Competition is a key theme of the ONC and CMS rules. They are designed to create a more level playing field and foster market-driven innovation. The intent is to cure the current innovation constipation afflicting health IT by empowering more players to get on the field and compete to provide the best, most innovative solutions at the lowest prices.
In this series, we will explore this theme of market-driven innovation by examining specific aspects of the proposed rules. We will look at why rules are needed and their expected impact including:
- Interoperability Technology: Application program interfaces (APIs) have transformed the rest of the digital economy. Why do the rules mandate the certification, adoption, and use of APIs as the next generation of interoperability infrastructure? What role will standards like FHIR play?
- Business Models and Intellectual Property: What practices inhibit competition and innovation? How do we balance the need for competition with protection of legitimate intellectual property rights and reasonable profit motives?
- Data: What specific data elements are part of the rules? Why is defining a core data set important?
- Health Insurance Data: What are the new requirements for health insurance providers and why are they important?
- Data Blocking: What is data blocking? How do the proposed rules address data blocking? What “exit ramps” are provided for patients and providers who want to switch from one application to another and/or take their data with them?
- Safety: How do the new rules address patient safety and promote the development of safer health IT applications and practices?
- Security and Privacy: How do the new rules impact patient privacy and the security of health data?
Health care has made substantial progress moving into the digital age and is positioned to build on this early success. Robust interoperability technology coupled with regulations designed to enhance competition are essential to accelerating and expanding this transformation. Digital technology has radically altered and largely improved the way we shop, bank, travel, and socialize. It’s now within our grasp to leverage this powerful technology to improve our health.
Dave Levin, MD is co-founder and Chief Medical Officer for Sansoro Health where he focuses on bringing true interoperability to health care. Dave is a nationally recognized speaker, author and the former CMIO for the Cleveland Clinic.