By Akash Jha, Healthcare Consultant at CitiusTech, and Diptarka Biswas, Healthcare Consultant at CitiusTech
The 21st Century Cures Act (the Act) — with its $6.3 billion in funding (some deferred) — is said to be the most important legislation passed since the Affordable Care Act (ACA). This sweeping piece of legislation has a broad set of goals: modernize clinical trials; streamline new drug and medical device approvals; provide funding for medical innovations, mental health, opioid prevention, and treatment; and increase interoperability in health IT (HIT).
It also provides for streamlined HIT oversight through a new HIT advisory committee, formed by consolidating all existing policy and standards committees. This committee will be charged with prioritizing and advising on new standards and implementation, specifications for HIT, as well as phasing out any outdated standards. From a HIT perspective, three key takeaways indicate significant opportunities for innovation and forward progress.
IT Innovation Moves To The Fast Track
The Act includes various provisions to streamline Food and Drug Administration (FDA) approvals for medical devices, software, and drugs. For medical devices, expanding upon the existing Expedited Access Pathway (EAP), the Act provides for establishing a “Breakthrough Device” pathway program for accelerated device approvals. This is especially beneficial for devices that target diseases for which no FDA-approved alternatives are available. It also provides guidance on expediting approvals for combination products — those that contain both a drug and a device. The FDA may use real-world evidence to approve a new indication of a previously approved drug and consider patient-experience data for drug approvals. For HIT companies, this opens the door to more innovation and faster time to market with new devices and software with the potential to improve patient outcomes.
Medical Software Is Distinguished From Medical Devices
On the software side, the FDA will exempt five categories of low-risk software from being regulated as medical devices:
- software for administrative support of healthcare facilities
- “healthy lifestyle” software that provides no diagnostic, prevention or treatment function — health apps on smartphones etc.
- software for transferring, storing or displaying medical device or clinical laboratory test data, but does not support interpretation or analyze clinical data
- software to acquire, process or analyze medical images from an IVD or signal acquisition system
Because these types of software solutions are classified as “posing no serious threat” to patients, they will no longer be regulated in the same way as medical devices. The FDA will also approve accessories based on usage rather than the device they are being used with.
The Act puts focus on EHR systems due to their broad impact on the healthcare industry and creates a reporting system on EHR usability, interoperability, and security by stakeholders. Going forward, the Office of the National Coordinator for Health Information Technology (ONC) will require continuous maintenance of EHR certification, requiring the software demonstrate its capabilities on measures that will be published by the Department of Health and Human Services (HHS). The reporting measures will be handled by third parties established under the HIT reporting grants program mentioned in the Act. The HHS will maintain a list of all EHR products on its site to help users choose according to their specific requirements. EHR vendors should note products can also be decertified and/or penalized based on complaint or unsatisfactory reporting.
Interoperability Moves Front And Center
The Act intends to increase the adoption and interoperability of EHRs and shines the spotlight on interoperability. At a high level, the Act seeks to reduce regulatory and administrative burdens on the use of EHRs, establishing standards for interoperability and all subsequent application and approval processes.
One of the biggest obstacles to interoperability to date has been EHR vendors that closely guard the data contained in their software, much to the frustration of healthcare providers and patients. As a provision of the Act, information blocking is strongly discouraged in any form, unless legally required, and strong penalties are implied. HIT developers will be required to make health data available using APIs and publish usability documentation for the same on their website.
To make progress toward complete interoperability, the Act suggests establishment of a Trusted Exchange Framework as a common agreement for exchange among all health information networks on a national level. This agreement will likely provide for a common method of authentication, a common set of rules for exchange and policies to enable the exchange. Furthermore, a national Provider Digital Index will be published and maintained by the HHS to provide centralized access to all relevant information for all providers.
The 21st Century Cures Act will undoubtedly have a large impact on HIT and the healthcare industry as a whole. Streamlining FDA processes and approvals for medical devices and making pragmatic adjustments to the regulation of software should stimulate innovation. At the same time, the regulation of EHRs should make the whole market more competitive and result in much more informed choices by customers, it remains to be seen if initiatives to increase interoperability, like the Trusted Exchange Framework, will bear fruit, in the long run.