“Now this is not the end. It is not even the beginning of the end. but it is, perhaps, the end of the beginning.” - Winston Churchill
The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have released Final Rules on interoperability, information blocking, and other activities as part of implementing the 21st Century Cures Act. The official roll out and Implementation of the rules begins on May 1, 2020 when they are published in the Federal Register.
In our previous blog series, we explored the ideas behind the Final Rules, why they are necessary, and the expected impact on interoperability, information blocking and innovation. A handy summary of the differences between the proposed and Final Rules can be found here.
Given that the rules are complex and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions.
While much of the world is focused on mitigating the health and economic impact of COVID19 another, potentially world-changing event is playing out in Washington, DC: The ONC and CMS Final Rules on interoperability and information blocking are entering the implementation phase. After years of development, debate and public input, the final rules were released on March 9, 2020 and will be published in the Federal Register on May 1, 2020 which will start the clock ticking on timelines for implementing and demonstrating compliance.
The Story So Far
Over the past decade, healthcare organizations widely deployed monolithic applications like electronic health records (EHRs). Advancing the digitalization of health care to the next stage will be highly dependent on innovators ability to build on that foundation to provide better, more diverse applications. This is why interoperability and data blocking are two of the biggest issues in health IT today.
Interoperability – the ability of applications to freely connect, exchange data, and collaborate within the health IT ecosystem – 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.
The Final Rules address a variety of concerns:
- Interoperability Technology. Application programming interfaces (APIs) have transformed other industries in the digital economy. The rules mandate the certification, adoption, and use of APIs as the next generation of interoperability infrastructure and a role for standards like FHIR (Fast Healthcare Interoperability Resources).
- Business Models and Intellectual Property. Select business practices inhibit competition and innovation. The rules seek to balance the need for competition with protection of legitimate intellectual property rights and reasonable profit.
- Data. A core data set for interoperability with specific data elements required.
- Health Insurance Data. There are significant requirements for health insurance providers to provide clinical data and provider directories.
- Data Blocking. Congress and ONC/CMS wisely recognized that interoperability can be limited due to a combination of technical barriers and behaviors. The rules define and address behaviors like data blocking and require "exit ramps" for patients and providers who want to switch from one application to another and/or take their data with them.
- Safety. They promote patient safety through the development of safer health IT applications and practices and by promoting transparency.
- Security and Privacy. The new rules impact patient privacy and the security of health data.
And We're Off
We are about to enter the implementation phase which formally starts when the final rules are published in the Federal Register. The rules include deadlines to achieve key milestones for functionality and compliance. Recently, in response to the distractions caused by COVID19, ONC and CMS announced additional "enforcement discretion" that relaxes some (but not all) of these deadlines. Key examples are shown in Table 1. below. A complete summary of the rules and enforcement discretion can be found here.
|Provision Compliance||Date/Timeframe Enforcement||Discretion Date/Timeframe|
|Condition of Certification (CoC) – Information Blocking||6 months after final rule publication||3 months after the compliance timeframe|
|CoC – Assurances – Will not take any action that constitutes information blocking or actions that inhibit access, exchange, and use of electronic health information (EHI)||6 months after final rule publication||3 months after the compliance timeframe|
|CoC – Assurances – EHI Export Rollout||36 months after final rule publication||3 months after the compliance timeframe|
|CoC – Communications – Notice to all customers with which developer has contracts or agreements containing provisions that contravene Communications CoC||Annually beginning in calendar year 2020||Notice can be made until March 31, 2021 for the 2020 calendar year|
|CoC – Application Programming Interface (API) – Compliance by Certified API Developers with health IT certified to current API criteria||6 months after final rule publication||3 months after the compliance timeframe|
|CoC – API – Rollout of new standardized API functionality||24 months after final rule publication||3 months after the compliance timeframe|
Table 1. Examples of Enforcement Discretion
Some have argued that the process should stop in response to the pandemic. Others note that had these rules been in place prior to the onset of COVID19, health IT would be in an even better position to respond to operational and clinical needs. Watching the massive rush to deploy telehealth solutions over the last few months one couldn’t help but wonder how much easier and better this would be were we further along on interoperability. ONC is seeking a proper balance between the need for progress and the acute demands of dealing with the pandemic. It plans to continue to "monitor the implementation landscape to determine if further action is needed."
Implementation of these provisions under the 21st Century Cures Act will be a major step forward for digital health in the US. With some luck and hard work, we will see substantial progress towards robust interoperability and the free flow of data for the benefit of patients and better clinical and financial outcomes.