In a healthcare marketplace increasingly driven by consumerism, it is critically important for patients to have access to data sufficient to enable them to be more informed, engaged and empowered to make decisions about their own care. Indeed, enhanced consumer engagement helps healthcare payors and healthcare providers improve patient acquisition and retention, strengthens brand value, lowers administrative costs, and leads to competitive advantages. Most importantly, greater consumer engagement can improve the health outcomes and quality of life of patients.
More than two decades ago, the Health Insurance Portability and Accountability Act (“HIPAA”) established minimum data privacy and security provisions for consumer health information. However, HIPAA and its progeny did not give healthcare consumers very much control over that data. Over the past decade, the United States healthcare industry has made tremendous strides in adopting and implementing electronic health records (“EHRs”). Unfortunately, such transition to EHRs has also caused frustration among providers who expected computers to make their care more efficient, and disappointment among patients who expect timely (on demand) access to their health information and seamless coordination of care. The primary cause of such frustration and disappointment is the lack of interoperability across hundreds of government-certified EHRs in use throughout the United States.
Interoperability refers to the software architecture or standards that make it possible for different EHRs to seamlessly exchange patient information, such as medical histories or diagnostic tests, through a secure network. The Healthcare Information and Management Systems Society (“HIMSS”) has identified three levels of health information technology interoperability, summarized as follows:
- “Foundational” interoperability allows data exchange from one information technology system to be received by another and does not require the ability for the receiving information technology system to interpret the data.
- “Structural” interoperability is an intermediate level that defines the structure or format of data exchange where there is uniform movement of healthcare data from one system to another such that the clinical or operational purpose and meaning of the data is preserved and unaltered.
- “Semantic” interoperability provides interoperability at the highest level, which is the ability of two or more systems or elements to exchange information and to use the information that has been exchanged.
See “Definition of Interoperability,” Approved by the HIMSS Board of Directors April 5, 2013.
Without interoperability, the expected benefits of EHRs cannot be fully achieved. One major hurdle impeding EHR interoperability in the United States is cultural. Accomplishing interoperability requires the coordination and collaboration among various stakeholders, including payors, patients, providers, and software vendors. In the information age in which we live, data is considered by some to be a commodity, which represents a competitive advantage and disincentives disparate stakeholders from working together to resolve these complex and technical issues. Moreover, both healthcare providers and software vendors have been accused of “Information Blocking” – intentionally interfering with the flow of information between different EHR systems – to maintain their perceived competitive advantages.
The good news for those looking forward to tangible progress in this area is that the United States government and the private sector have taken a series of steps over the past several months to meaningfully address issues relating to the lack of interoperability of EHRs.
21st Century Cures Act
The 21st Century Cures Act (“Cures Act”), signed into law by former President Obama on December 13, 2016, addressed a broad spectrum of healthcare issues relating to medical research and the approval process for new drugs and medical devices. The Cures Act also contained a number of provisions encouraging interoperability of EHRs and patient access to health data, as well as discouraging Information Blocking. According to the Cures Act, EHR interoperability are those technical frameworks which allow for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law and which do not constitute “Information Blocking.”
With respect to health information technology developers, the Cures Act defines Information Blocking as exchange, or network, business, technical, or organizational practices that, “except as required by law or specified by the Secretary, interferes with, prevents, or materially discourages access, exchange, or use of electronic health information; and the developer, exchange, or network knows, or should know, are likely to interfere with or prevent or materially discourage the access, exchange, or use of electronic health information.”
The Cures Act imposes steep penalties on those developers, exchanges, and networks found to have engaged in Information Blocking and who have submitted a false attestation, subjecting violators to civil monetary penalties up to $1 million per violation. The Cures Act directed the Office of the National Coordinator for Health Information Technology (“ONC”) to define exceptions so that HHS’ Office of the Inspector General knows which practices to penalize. ONC will soon be issuing its long-awaited proposed rule to implement proposed regulations distinguishing between prohibited health Information Blocking and other permissible restrictions on access to health information.
In March 2018, the Trump Administration announced the government wide “MyHealthEData Initiative,” to be spearheaded by the White House Office of American Innovation and designed to improve EHR patient data access by breaking down existing barriers to health data access and use.
The MyHealthEData Initiative aims to allow patients to receive copies of their entire EHRs, share their personal health data with anyone they choose, and put themselves at the center of the healthcare system. As the CMS announcement stated, “[t]he MyHealthEData initiative will work to make clear that patients deserve to not only electronically receive a copy of their entire health record, but also be able to share their data with whomever they want, making the patient the center of the healthcare system. Patients can use their information to actively seek out providers and services that meet their unique healthcare needs, have a better understanding of their overall health, prevent disease, and make more informed decisions about their care.”
Tech Giants Issue Joint Statement
On August 13, 2018, several large technology companies including Amazon, Google, Microsoft, IBM, Salesforce, and Oracle issued a joint statement affirming their commitment to advancing healthcare interoperability and health data exchange (the “Joint Statement”).
The Joint Statement, which coincided with the CMS Blue Button 2.0 Developer Conference in Washington, D.C. Blue Button 2.0 is an initiative by the Centers for Medicare & Medicaid Services (“CMS”) intended to allow Medicare beneficiaries to share with new doctors health data, previous prescriptions, treatments, and procedures. CMS first launched Blue Button in 2010 to give patients access to their claims data in a downloadable PDF file. It is anticipated that Blue Button 2.0 will lead to lower rates of duplicative testing, improve continuity of care, and streamline billing activities.
The Joint Statement began by stating: “We are jointly committed to removing barriers for the adoption of technologies for healthcare interoperability, particularly those that are enabled through the cloud and AI.” The Joint Statement listed four foundational assumptions that will form the basis of their efforts to improve interoperability, including (i) the frictionless exchange of healthcare data; (ii) interoperability which meets the needs of all global stakeholders; (iii) open standards, open specifications, and open source tools; and (iv) a commitment to actively engage among open source and open standards communities for the development of healthcare standards, and conformity assessment to foster agility to account for the accelerated pace of innovation
The technology companies also pledged to develop tools based on the vendor-agnostic HL7 and Fast Healthcare Interoperability Resources (“FHIR”), a draft standard describing data formats and elements and an application programming interface (“API”) for exchanging electronic health records. Apple is also utilizing FHIR to allows users to aggregate and view health information from different EHR systems and healthcare organizations on iOS devices such as iPhones, iPads and wearable devises such as the Apple Watch.
The launch of the Trump Administration’s MyHealthEData Initiative, the implementation the provisions of the Cures Act relating to interoperability and Information Blocking, and the focus by the titans of the technology sector on efficient health data exchange have finally set the United States healthcare industry on the path to achieving EHR interoperability and should eventually put the consumer at the center of control over his or her own health information and data.
Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a New York law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.
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