The Office of the National Coordinator for Health Information Technology (ONC) reported to Congress on the extent of health information blocking, which occurs when persons or entities knowingly and unreasonably interfere with the exchange or use of electronic health information. The ONC report detailed a comprehensive strategy to address health information blocking, including current and proposed actions in coordination with HHS and other federal agencies.
Since the enactment of the HITECH Act and subsequent legislation, the federal government has invested over $28 billion in incentives to accelerate the development and adoption of electronic health records (EHR). The purpose behind the government’s efforts is to establish an interoperable health information technology (health IT) system, one in which electronic health information is readily available, and securely and effectively shared. The goal of such a system is to support patient-centered care and enhance health care quality, as well as advance research and public health.
The Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) further emphasized the role of health IT and health information exchange in health care. The ACA provides incentives for the use of health IT and health information exchange, both through direct requirements for the use of health IT in certain quality reporting programs, and indirectly through new reimbursement policies and value-based payment programs that require advanced health IT and health information exchange capabilities
The ONC, however, found that current economic and market conditions create business incentives for some persons and entities to exercise control over electronic health information in ways that unreasonably limit its availability and use. This interference frustrated the overall goals of the HITECH Act and undermined broader health care reforms.
Today, over 75 percent of eligible providers and 90 percent of eligible hospitals have received incentive payments for adopting and meaningfully using certified health IT, and more than 60 percent of hospitals have electronically exchanged patients’ health information with providers.
Conduct defined, findings
The ONC distinguished conduct that, while interfering with the exchange or use of electronic health information, was unlikely to be characterized as information blocking from conduct that would be be classified as blocking. The ONC defined the three criteria for information blocking as: interference, knowledge, and no reasonable justification. Where conduct is not characterized as blocking, systemic barriers to interoperability and electronic health information exchange could cause entities to act in a manner that undermined effective information sharing for reasons beyond their control.
Conduct, however, that would be categorized as blocking, included business, technical, and organizational practices that:
- restricted individuals’ access to their electronic health information or the exchange or use of that information for treatment and other purposes via contract terms or business policies;
- charged prices or fees to make exchange or use of electronic health information cost prohibitive;
- developed or implemented health IT in non-standard ways to increase the costs, complexity, or burden of sharing the electronic health information, especially when interoperability standards have already been adopted by the government; or
- developed or implemented health IT to “lock in” users or electronic health information, impeding innovations and advancements in health information exchange and health IT care delivery.
The ONC also found that health care providers have been accused of information blocking, most commonly when a hospital or health system is accused of blocking to control referrals or enhance market share. In turn, providers attest that the constrained access is for compliance with privacy and security requirements. The ONC reported that privacy and security laws are cited in circumstances in which they do not in fact impose restrictions. For example, providers may cite the Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191) Privacy Rule as a reason for denying the exchange of electronic protected health information for treatment purposes, when the Rule specifically permits such disclosures.
A key finding of the ONC was that many types of information blocking were beyond the reach of current federal law and programs. Significant gaps in current knowledge, programs, and authorities limited the ability of ONC and other federal agencies to effectively target, deter, and remedy the health information blocking. Moreover, any successful strategies to prevent health information blocking would likely require congressional intervention.
According to the ONC, addressing these broader challenges will require, among other efforts:
- continuing public and private sector collaboration to develop and drive the consistent use of standards and standards-based technologies that enable interoperability;
- establishing effective rules and mechanisms of engagement and governance for electronic health information exchange;
- fostering an environment that is conducive to the exchange of electronic health information for improved health care quality and efficiency; and
- clarifying requirements and expectations for secure and trusted exchange of electronic health information, consistent with privacy protections and individuals’ preferences, across states, networks, and entities.
The ONC highlighted its published draft Shared Nationwide Interoperability Roadmap as continued commitment to overcoming the broader challenges faced by government, industry, and the health IT community (see Long awaited roadmap for health IT odyssey unveiled by the ONC, Health Law Daily, January 30, 2015).
The ONC cited that it cannot take direct action against providers who block information, and current conditions of participation in federal health care programs do not specifically prohibit information blocking.
The ONC report detailed various means of addressing health information blocking. For instance, the ONC HIT Certification Program could be utilized as an avenue. The ONC HIT Certification Program vests responsibility for certifying and ensuring ongoing conformance of health IT in ONC-Authorized Certification Bodies (ONC-ACBs). The ONC-ACBs must provide proactive and reactive surveillance of the health IT they certify in order to maintain their accreditation and authorization to issue certifications on behalf of the ONC.
In instances of an ONC-ACB substantiating non-conformance, the ONC-ACB, in collaboration with the ONC, can implement corrective actions, including: (1) continuation of the certification under specified conditions, e.g. increased surveillance; (2) suspension of the certification pending remedial action by the developer; and (3) termination of the certification.
Another method to reduce information blocking is to promote transparency in the health IT marketplace. The ONC reported that providing customers with reliable and complete information about health IT products and services would make developers more responsive to customer demands, reducing the market distortions that incentivize developers to engage in certain opportunistic behaviors that raise serious information blocking concerns.
Moreover, many types of information blocking could be mitigated by encouraging or requiring providers and developers that facilitate the exchange of electronic health information to adhere to certain basic expectations related to the availability and sharing of information for purposes of patient care. In limited circumstances, some types of information blocking may violate state or federal law. The ONC would provide assistance where appropriate to help federal and state law enforcement agencies identify and investigate such conduct.