21st Century Cures Act: Interoperability Beyond Boundaries
September 5, 2017
I recently attended a meeting of the US Office of the National Coordinator for Healthcare IT (ONC) called “Beyond Boundaries: ONC’s 2017 Technical Interoperability Forum.” For those of us in the US, this meeting laid the groundwork for Healthcare IT interoperability plans and regulations coming in the next few years, where the government—and industry in large part—will be focusing on certifications and improving areas of interoperability.
At Infor, we feel it’s important to be engaged in the activities of the ONC and other industry initiatives to positively influence them and to act as a ”surrogate” for our customers that may not be able to send representatives personally. As part of that effort we also feel it is our duty to keep you updated on these activities and the direction we see the industry heading through blog posts like these.
Based on the meeting I recently attended, the biggest driving factor for the ONC is a piece of legislation called the 21st Century Cures Act, sometimes referred to as the Cures Act, which was signed into law in December 2016. This law covers several topics including the opioid epidemic, the FDA drug approval process, medical research, and behavioral health, just to name a few. “Title IV – Delivery” will probably be of most interest to you because it addresses regulatory burdens, interoperability, information blocking, patient access to health information, and more. Many of these provisions from the HHS or ONC include completion deadlines of 1 year to 18 months. Here’s a quick summary and my take on what’s currently happening.
Reduction of burdens
This seeks to reduce the regulatory and administrative burdens of providers related to EHR use by developing a strategy and recommendations that prioritize areas such as:
- Incentive & reimbursement programs (MU, MIPS, APMs, etc.)
- HIT certification
- Electronic health information privacy and security protection
- Patient access to their electronic health information
- Public health, research, administrative reporting, and quality measures
Electronic health record technology certification
This certification mandates that the ONC modify requirements to address specific areas of interest including:
- Medical specialties and pediatrics
- Information blocking
- Inhibiting communication regarding usability, interoperability, security, and user experience of EHR technology (for example, no contractual obligation of confidentiality)
- Providing access to all data elements of a patient’s electronic health record via published APIs
- Real world testing
This area requires the reporting of Meaningful Use attestation statistics and creates an exception for providers using EHR technology that has been decertified.
EHR reporting program
This program requires the development of reporting criteria that will address such areas as:
- Usability & user centered design
- Certification testing
- Optional areas like diagnostic orders and results, data registries, HIEs, medical devices, patient generated information, and others
Trusted exchange framework
This framework requires the development of policy and practices for interconnectivity of health information networks, which will include requirements on authentication, rules for exchange, and adjudication of non-compliance.
Provider digital contact information
This provision provides for creation of a provider contact directory that includes individual and organizational (health system) level contact information.
Health Information Technology Advisory Committee
This provision creates a committee that replaces the previous HIT Policy Committee and HIT Standards Committee FACAs. The new committee of at least 25 members will focus on a smooth transition from the previous committees as well as interoperability, security and privacy, improving healthcare, addressing the needs of underserved populations, and self-service, telemedicine, home health, and remote monitoring, among others. The recommendations of this committee will be used to foster improvement in the respective areas through activities such as pilots, and to inform future certification requirements.
This provision defines penalties and the definitions and processes regarding such penalties for information blocking by providers and HIT developers.
Site of service price transparency
This provision seeks to increase price transparency at the site of service.
Having outlined provisions of the Cures Act, the ONC meeting consisted of presentations and panel discussions followed by a question and answer session with the audience in attendance.
The agenda included some of the following topics:
- Information blocking
- Semantics (mostly a discussion about the use and challenges regarding clinical terminologies)
- Interoperability networks and creating a nationwide trusted exchange framework
- Fit for Purpose, which identifies the right standard(s) for the right job
- APIs and apps
- Data availability, aggregation, and services
Looking at these topics you can see that the ONC is laser focused on the Cures Act. Since this act and the ONC’s regulatory and coordination activities will affect the industry in a material way, it would be good to look at several of these topics in a bit more detail. This post represents the first in a series we will call “Interoperability Beyond Barriers.” We will be covering most of the topics that were discussed in the meeting over upcoming blog entries.
If there are additional topics or initiatives you would like to see us cover, please let us know your ideas or questions.
-Corey Spears, Director of Healthcare Interoperability Standards
- North America