- The Bipartisan Policy Center and Health IT Now have joined forces to establish an oversight framework to encourage health IT innovation and improve EHR usability, interoperability, and safety.
“To inform and support the administration and Congress as they work to improve the development and use of health technology through regulatory reforms, Health IT Now and the Bipartisan Policy Center have convened a Work Group on the Future Role of Government in Health IT and Digital Health,” wrote authors of the report.
The workgroup comprised more than 50 experts and stakeholders across the industry including organizations representing clinicians, consumers, patients, hospitals, health systems, and health IT companies. The team assessed the current state of health IT regulation to determine the most immediate and significant needs of users and develop recommendations about the changing role of government in the current healthcare system.
Overall, the workgroup determined the government should primarily focus on consumer protections related to EHR systems and other related technologies.
“A core and shared belief is that the development and advancement of features and functions beyond core consumer protections should be left to the private sector,” authors clarified.
“The federal government should also continue to play a role in non-regulatory functions, such as funding research to identify successful practices and adopting consensus standards within its own health IT to signal government support,” they continued.
The workgroup determined the oversight framework should be risk-based, stable, predictable, accountable, and enforceable. Additionally, the framework should encourage innovation and reflect the principles of a learning health system.
“This means that the framework should undergo continuous improvement and innovation, with best practices seamlessly embedded as new knowledge is captured through experiences,” authors wrote.
Ultimately, the framework aims to promote the development of technology that supports high quality, patient-centered care. By extension, the oversight framework should promote EHR usability, interoperability, safety, and security. The framework should also ensure the development of technology that allows for improved patient access to information and supports an ever-evolving healthcare system.
To achieve these objectives, the workgroup recommended the federal government take the following four steps:
- Provide assurance that core consumer protections are met. The federal government should carry out its traditional role of assuring core consumer protections. Any other regulatory activities should be transitioned to private sector accreditation, certification, recognition, and/or standards bodies or–if appropriate–eliminated.
- Recognize standards and promote their adoption. The federal government should recognize private sector consensus standards, adopt such standards within federal programs, utilize market-sensitive policy levers–such as incentives, rather than technology mandates or penalties–to promote their adoption and use, and support adoption through educational efforts.
- Convene experts and stakeholders. The federal government should continue to serve in the role of convener, by bringing together stakeholders and experts to identify health IT and digital health-related issues that need to be addressed and strategies to address those challenges.
- Fund research and development activities. The federal government should invest in research and development activities designed to assess the current state of the field, define key challenges, and identify best practices and other solutions
To transition to this new role, the federal government should continue to enforce existing laws and regulations that create a level playing field for health IT developers and reduce the scope of the ONC health IT certification program, authors advised. Authors also recommended that HHS continue to implement the aims of the 21st Century Cures Act, and suggested CMS reduce the amount of prescriptive requirements part of federal incentive programs.
Authors subsequently detailed ways the federal government can apply these recommendations to interoperability, usability, safety, and other health IT improvements.
To improve interoperability, the workgroup recommended the government design payment models around strong business cases and clearly identify ways stakeholders can engage in interoperability and health data exchange.
Additionally, authors suggested the federal government recognize health data exchange standards that exist in the private sector and work to improve and implement widespread standards development, among other recommendations.
Authors recommended the government promote usability improvements by re-examining current health IT regulatory requirements to eliminate provisions that increase provider burden. Authors also suggested the federal government encourage the private sector to implement usability assessments of health IT products and limit ONC’s role in assessing usability, among other suggestions.
“Nearly 10 years after the passage of the HITECH Act, the time is now to update the course of federal health IT policy,” concluded authors. “We encourage Congress, the administration, and the private sector, to take up this challenge and meet this opportunity.”