The 21st Century Cures Act (“Cures Act”) and the regulations on interoperability and information blocking promulgated thereunder by the Office of the National Coordinator and the Centers for Medicare & Medicaid Services accelerate information sharing across the health care sector. Various stakeholders across the health care ecosystem must now navigate these new and complex rules on sharing electronic health information in order to gain the benefits of such sharing while avoiding the potential risk of noncompliance.
The Cures Act information-blocking prohibitions can carry stiff penalties of up to $1 million per violation. Organizations subject to these rules are faced with the tough choice of embracing and learning how to share information compliantly or confronting the risk of enforcement, including monetary penalties and reputational risk. Further, the Cures Act interoperability requirements are rooted in a technological mandate for all certified electronic health records (EHRs) to have standards-based application programming interfaces that can exchange an increasing amount of data elements over time across different systems. But sharing data is not without risk, and organizations should proactively consider building compliance and contracting programs that balance sharing with privacy, security, safety, and other dimensions of risk.
EBG can offer clients an interoperability compliance toolkit that includes the following:
Compliance program development and audit: Actors will need effective compliance programs to identify when an exception to the default to share may require an actor to decline to disclose electronic health information or an alternative manner can be negotiated. EBG can assist with the development and auditing of an existing program.
- Assess existing information access, use, and disclosure policies to identify gaps and omissions that need to be updated to address the new information sharing paradigm that has been ushered in by the Cures Act.
- Review and update existing agreements, e.g., services, licensing, and business associate, to ensure they comply with the communications requirements and allow flexibility to share information while limiting liability.
Strategic advising: The industry must adjust to the new normal of digital platform engagement, health apps, and information sharing.
- Health care providers can discover the efficiencies of being able to engage with patients between visits and have a greater influence on their healthy successes rather than only having the opportunity to treat patients episodically when they are sick.
- Entities and organizations that meet the functional definition of a “health information exchange” will learn how to identify their role as health record aggregators and will be able to contribute to building the infrastructure that the Trusted Exchange Framework and Common Agreement envisions.
- As platform technologies begin to offer flexibility for information sharing, Certified EHR developers will learn to separate a patient’s data from their applications and will be able to contribute to a learning health system. There will be new opportunities to develop artificial intelligence and machine-learning tools that will add value to providers, health systems, and patients. New markets in research, pharma, connected devices, monitoring tools (the MIoT), and public health will open up as technologies expand and mature.
- Interoperability solutions designed by health IT developers that help solve frustrating or complex problems in health care—such as how to find the right primary care doctor or specialist that is in your network, which imaging center or lab offers the best prices and hours of operation, where to find the lowest prices for the pharmaceuticals your doctor has prescribed or how to find and get enrolled in the right clinical trial—could easily become the most popular.