Better regulation can eliminate high-cost barriers to the integration of electronic health records.
In 2016, President Obama signed the bipartisan 21st Century Cures Act. The law aimed to enhance the U.S. health care system in many ways. It sought to accelerate medical product development, improve health data interoperability, and prevent “information blocking”—practices that impede the exchange or use of electronic health information. The Act focused on advancing precision medicine, bolstering mental health care, and combating the opioid crisis. It provided funding for critical research initiatives, including the Biden Administration’s Cancer Moonshot initiative, and it aimed to strengthen the health care workforce.
Patients already had the right to access their health information under the Health Insurance Portability and Accountability Act of 1996. Before the 21st Century Cures Act, however, this access was often limited and challenging due to issues such as long waiting times, fees, and difficulty sharing health data. Recognizing the immense value that open and accessible health data could provide for driving innovation, facilitating medical research, and improving patient care, the 21st Century Cures Act aimed to break down barriers to data sharing and promote interoperability.
Furthermore, the Act emphasized the importance of empowering patients by ensuring access to their own health information. This approach aligned with the growing recognition that patients should play an active role in their health care journey and have the ability to share their data with third-party apps and services that could enhance their overall well-being.
The Health Information Technology for Economic and Clinical Health Act (HITECH), enacted in 2009, was a significant precursor to the 21st Century Cures Act in promoting the adoption and meaningful use of health information technology. HITECH led to billions of dollars’ worth of investment for the wide adoption of electronic health records (EHRs). As a result of these initiatives, EHRs are now ubiquitous in health care settings across the United States, fundamentally transforming how patient information is recorded, stored, and shared.
Although this digital transformation has greatly improved patients’ ability to access their own health data, a significant disparity has emerged for third-party app developers and companies seeking to integrate with EHR systems.
App development is necessary in health care to drive innovation, improve patient outcomes, and enhance the overall efficiency of health care delivery. Mobile and web apps can provide patients with easier access to their health information, facilitate remote monitoring, improve medication adherence, and offer personalized health management tools. For health care providers, apps can streamline workflows, aid in clinical decision-making, and improve communication with patients and other health care professionals. To function effectively, many of these health care apps require integration with EHR systems to access and use patient data.
This integration is crucial for providing real-time, accurate information to both patients and providers, ensuring continuity of care, and enabling advanced features such as predictive analytics and personalized treatment recommendations. But EHR integration is costly. Reports have surfaced of some fees reaching over $700,000 per year.
The Office of the National Coordinator for Health Information Technology (ONC) is one of the primary agencies involved in interpreting and enforcing the 21st Century Cures Act’s goals of improving interoperability and preventing information blocking in the health care sector. ONC’s interpretation of the law allows EHR vendors to charge “reasonable” fees for third-party access, ostensibly to cover their costs. The ambiguity surrounding the definition of reasonable fees and the lack of clear guidance or enforcement mechanisms, however, have created a potential loophole that could be exploited by major EHR players.
Skeptics contend that some EHR vendors take advantage of this regulatory ambiguity by imposing integration fees that are disproportionately high compared to their actual expenses. These exorbitant fees charged to technology companies, developers, and other entities seeking to access and exchange data can create significant financial barriers, effectively impeding the broader data use and exchange capabilities envisioned by the 21st Century Cures Act.
Although patients themselves maintain the right to affordable access of their own records, the high fees imposed on third-party entities can indirectly limit patient access to innovative apps and services that could leverage health data to improve care and outcomes. This situation raises concerns about whether the regulations are achieving their intended goals of fostering an open and interoperable health care ecosystem.
EHR vendors, however, maintain that their fee structures are justified. They argue that the revenue generated from these charges is essential for continual investment in crucial areas of health care information technology. This includes enhancing data security measures, developing and maintaining interoperability tools, and driving innovation in health information technology. These vendors contend that such investments ultimately benefit the entire health care ecosystem by improving the quality, security, and functionality of EHR systems.
To address this ambiguity and strike the right balance, further regulatory clarification or the introduction of new rules specifically governing data access fees for third-party companies and apps may be necessary.
One approach involves defining a transparent and standardized methodology for calculating reasonable integration costs, which would include establishing clear cost categories, allocation guidelines, and standardized formulas.
Another solution suggests implementing fee caps or tiered pricing structures based on the size or nature of the third-party entity, potentially offering lower fees for non-profits, startups, or organizations serving underserved populations. In addition, requiring EHR vendors to provide detailed cost breakdowns and subjecting them to audits could increase transparency and accountability.
Finally, establishing an independent arbitration process that relies on impartial experts, could help resolve disputes over integration fees.
These proposed solutions collectively aim to strike a balance between allowing EHR vendors to recoup legitimate costs while ensuring fair access for third-party developers and ultimately promoting innovation in health care technology.
Ultimately, the issue of third-party integration fees and the ambiguous regulation interpreting the 21st Century Cures Act highlight the complexities involved in balancing competing interests and objectives within the health care ecosystem. As technology continues to advance and the potential for data-driven innovation grows, regulatory frameworks must evolve to keep pace.
Moving forward, a collaborative and iterative approach involving all stakeholders—regulators, EHR vendors, health care providers, technology companies, and patient advocates—will be essential.
