Procuring Interoperability: Achieving High-Quality, Connected, and Person-Centered Care (2018)
Chapter: IV. Transforming the Health IT Marketplace
IV.
TRANSFORMING THE HEALTH IT MARKETPLACE
Smarter procurement of interoperable health IT—including both the technical architecture and the business infrastructure—is not only necessary to help solve quality and workflow challenges today, but also crucial for surviving and thriving in the rapidly changing health care landscape. As in most sectors, health care delivery is undergoing rapid changes, on both the data and the consumer fronts (Brigham and Johns, 2012; Flores et al. 2013). New data streams—structured and unstructured—are cascading into the health care realm from fitness devices, genetics and genomics, social media, and public health sources. Aggregating and processing such an explosive growth of data to allow predictive insight—through machine learning and clinical decision support, for instance—can provide timely, evidence-based, and customized solutions to optimize care (Kesselheim, Cresswell et al., 2011). Consumers, not just patients, are more participatory than ever before in managing their health; health care will no longer be confined to physicians’ offices and hospitals. Preventive strategies and wellness promotion will be an integral part of health care—a transition toward continuous care from episodic care, and an expansion of horizon from points of care to points of life. In late 2016, Kaiser Permanente of Northern California reported that it interacted more with patients virtually (e-mail, video, and telephone) than in-person, underscoring the growing importance of telehealth technologies in health care delivery (Tuckson, Edmunds et al., 2017). Finally, given growing security threats and the sensitivity of personalized data, health care systems will be accountable for their protective role of patient privacy and security in health data transmission and storage. All these opportunities and challenges on the horizon require health care leaders to ensure their technology infrastructure can progressively become more interoperable, secure, and adaptable to new advances.
A SHARED VISION
Looking ahead, the most compelling aspiration of accelerating an interoperable health IT infrastructure is to support a person-centric, high-value, and continuously learning health system. In an ideal state, the person—and all of the surrounding systems and devices—are “known” entities and can integrate and share information seamlessly and for mutual benefit. As an individual enters or leaves a health system, information associated with each episode of care becomes a part of his or her longitudinal record for continued use both within and outside of the health delivery system. The medical record of the future is continuous, dynamic, and mobile and has built-in attributes that make an individual known, understood, and cared for with greater wisdom and precision.
Interoperable clinical and nonclinical data, coupled with analytic tools to filter signals from noise, will be foundational for any care delivery system that thrives for delivering timely, coordinated, outcome-focused, and patient-centered care. Data exchanges are extensive and speedy, mediated through trusted and secure mechanisms. Health care systems can acquire new health IT software or hardware components to enhance care quality or fill service gaps from multiple vendors that offer compatible modules with clear performance and price specifications. Established corporations and entrepreneurial businesses alike can bring innovative IT products to market with enhanced capabilities and uses that work seamlessly with existing architecture. Patients and consumers can access their own health information, determine which parties are granted access to their data, and actively participate in their own health and health care regardless of their demographic background, financial means, geographic location, and technology savviness.
ACTION AGENDA
A person-centric model allows patients, providers, vendors, and regulators to collaborate in an informed and synchronistic way that will significantly improve the safety of health care delivery, but it cannot be created without the cooperation, support and initiative of the entire health care community. Despite some promising pilot efforts, the health care sector is still substantially distant from integrating technology and sharing data across care settings in a way that will inform providers and patients in making smarter and safer decisions at the point of care. Health care applications in particular will need more efficient ways to combine and convert data from multiple sources, including automating conversion from unstructured to structured data (Raghupathi and Raghupathi, 2014). In the health IT marketplace, a collective move toward open architecture and an
open business model will increasingly remove barriers of adopting new applications and devices, which will enable organizations to make nimble technology investments to support an overall trend toward shared risk management and accountability.
Despite the multipronged advances in promoting interoperability, the field is in a very early phase in terms of converging on a common approach to be adopted widely. The difficulty with regard to health care technology is that advances have been so rapid, and solutions have been so complex, that the “natural” evolution toward standardization faces many barriers. If progress is to be made anytime soon, it will require significant demand from users, to use marketing terminology, rather than waiting for a push from suppliers. This is particularly true at the point of care. Rather than continuing to be constrained by the high-cost proprietary status quo, in an ideal state, health systems would work with payers and device manufacturers to demand and adopt a platform that is standards based, addresses one-to-many communication, allows two-way data exchange in real time, and enables comprehensive integration of devices and systems. Standards development must include the creation of clinical use cases with conformance test tools that measure the quality of the standards and show they meet the needs of relevant use cases and workflows.
ROLES OF HEALTH CARE PROVIDER ORGANIZATIONS
Many health care organizations recognize the potential benefits—including improving care, increasing operational efficiency, and lowering costs—that are achievable through the seamless exchange of information and technology integration. However, it will always be a balancing act and leadership dilemma in pursuit of better technology and other competing priorities and resource constraints. Further, innovation accelerates at such a pace that a single health delivery system cannot confront the complex and costly tasks of data and technology integration on its own. At its root, the lack of interoperability is not merely a technical problem but is also a business-interest problem, and it is a fundamental problem on social and moral grounds. As the organizations buying, implementing, and using technologies to care for patients, health care providers can and must transform the technological underpinnings of the health care industry. Purchasers can reward vendors and developers that work together to adhere to the agreed-upon blueprint, thereby instilling confidence that solutions will work as expected, safely and securely (Cantwell and McDermott, 2016) as well as partner to create sufficient incentives to drive transformative change in the marketplace.
For health care organizations increasingly called upon to serve as population health stewards, lack of data liquidity and interoperability also impedes effective collaboration with community partners in providing effective and efficient whole-person care. At the macro-tier, data hoarding and data blocking remain common practice—which requires a combination of regulatory disincentives and, more importantly, a cultural shift. The 21st Century Cures Act’s provision for civil penalties on information blocking serves as one exemplary policy lever, but a substantive cultural shift will require a concerted effort from many stakeholders. Health care providers, group purchasing organizations, payers, and other end users of health data must work together to accelerate bidirectional exchange of clinical, claims, care management, and psychosocial data that enables the ability to stratify patients according to risk, close gaps of care, and drive the development of a longitudinal patient record embedded in provider workflows.
Health care organizations and their service providers must also increase their investment in information risk management to protect against privacy breaches and cyberattacks. New threat agents such as state-sponsored hackers and ransom-ware, coupled with new vulnerabilities such as insufficiently protected devices and unpatched applications, have increased the ease and the rewards of stealing health information.
As market navigators and knowledge brokers, group purchasing organizations (GPOs) may also play a role in ushering collective purchasing power to send a clear signal to the marketplace (United States Government Accountability Office, 2010). With approximately 72 percent of hospital purchases contracted through GPOs, these organizations command sizable buying influence (Dobson DaVanzo & Associates, 2014). GPOs and similar advisory entities should provide technical contracting support to ensure their buyers’ demands for connectivity are met with requiring the best-in-class standards, which are specified in the RFPs in detail. Doing what they do best, GPOs may then help achieve affordable solutions as health care systems continuously enhance interoperability and security of their health IT infrastructure.
The unified voice of the leaders of health care provider organizations consistently demanding interoperability from vendors would benefit purchasers and sellers alike, because the need to create and support custom solutions imposes a financial burden on vendors. For vendors, a centralized approach that specifies common requirements in RFPs and contracts could provide a focal point for engaging customers in solving shared technical challenges and could make enlisting the help of other industries easier. Breaking legacy paradigms is one of the most challenging, yet most critical, aspects of revamping data flow in health care. Learning from other industries that have conquered similar challenges is
important, particularly how wide adoption of an open architecture business model eventually spurs innovations, resulting in more product choices and lower costs. Appendix A, Section 4 describes two case studies from the defense industry.
ROLES FOR THE FEDERAL GOVERNMENT
As a payer, provider, and regulator of health care, the federal government asserts substantial influence over the speed of health IT interoperability. In addition to various steps taken to incentivize greater interoperability as directed by the ONC Interoperability Roadmap, the federal government can also provide a platform for fostering macro-, meso-, and micro-tier interoperability while ensuring privacy and security. For example, it can help improve requirements specification through standards, develop methods and procedures to test systems against these standards, provide a testing infrastructure, help communities in building test tools, establish a clearinghouse to curate and catalogue software systems and point-of-care devices, and ensure that appropriate methodologies are available to various stakeholders for achieving interoperability. The federal government should also continue to publish test results (on websites such as the ONC Certified Health IT Product List and Office of the National Coordinator for Health Information Technology) of the different vendor systems to facilitate an open market for components that are interoperable for integration into customized architectures. Moreover, federal agencies should develop a consistent framework to incorporate interoperability in its IT product certification programs or criteria of approval for certain medical devices. As new privacy and security threats quickly evolve, regulatory agencies also need to respond with new rulings and guidance. For example, the Food and Drug Administration (FDA) issued guidelines for medical device manufacturers and health care facilities to take steps in ensuring that medical equipment does not become a vector for cyberattacks.
The 21st Century Cures Act provides several opportunities to spark further advances in health IT interoperability. This includes the establishment of penalties for information blocking ($1 million per occurrence), which could play a role in macro-tier data exchanges. ONC’s enforcement of the Act by activating the Trusted Exchange Framework and Common Agreement (TEFCA) can be a strong vehicle to drive adoption of interoperability. As of March 2018, the ONC had received more than 200 public comments on the proposed draft TEFCA, including from the Health Information Technology Advisory Committee. Three potential outcomes are expected from the final configuration of TEFCA. First, patients can access their health information electronically without any special
effort. Second, providers and other accountable organizations can receive necessary and appropriate information about a group of individuals without having to access one record at a time. This allows them to analyze population health outcomes, identify at-risk populations, and track progress on quality improvement initiatives. Third, the health IT community can have open and accessible APIs to encourage entrepreneurial, user-focused innovation to make health information more accessible and EHRs more usable. By the end of 2018, a recognized coordinating entity will be selected that uses TEFCA’s policies, procedures, technical standards, principles, and goals to develop a single Common Agreement that Qualified Health Information Networks and their participants can voluntarily adopt.
The federal government can also provide incentives for providers and vendors to enhance interoperability, including but not limited to adopting recommended standards, as well as disincentives for information blocking. With a synergistic goal of empowering patients through access to their health care data, in March 2018 the White House Office of American Innovation and the Centers for Medicare and Medicaid Services (CMS) launched the MyHealthEData initiative. The initiative aims to break down barriers that prevent patients from having electronic access and control over their own health records from the device or application of their choice. One example is the Blue Button 2.0 API, which leverages the FHIR standard to enable Medicare beneficiaries to share their claims data with third-party application developers. The CMS also announced the intention to overhaul its EHR Incentive Programs—now referred to as the Procuring Interoperability program—to streamline the Meaningful Use and the Quality Payment Program and intensify focus on interoperability, preventing information blocking, and reducing reporting burden. Ongoing considerations in expanding technology certifications beyond EHRs and in providing clarity on the consequences of using noncertified technologies can further drive market incentives. These laudable plans, if followed by rules and programs reflecting careful considerations of stakeholder inputs and backed with sufficient resources, can fuel a movement toward patient-centered interoperability for the field.
Finally, as a major provider of health care and purchaser of health care IT products, federal agencies should continue to share their procurement practices, vendor lists, and interoperability requirement specifications with the public. As pioneers in adopting a standards-based process for procurement of interoperable and secure health technology, the Departments of Defense and of Veterans Affairs represent strong buying power and knowledge hubs. When working in concert with other health care providers and payers, the health IT marketplace
can be propelled in a new direction. Referenced previously, Box 1 described initiatives at the Department of Defense. A related initiative of central importance is underway at the Department of Veterans Affairs; Box 2 details ongoing health IT procurement strategies, aiming to continuously improve veteran care and support interoperability nationwide.
ROLES FOR PAYERS
Although the majority of this assessment focuses on health care providers who acquire health IT products through procurement, payers also play a pivotal role in shaping the marketplace incentives and norms. Both public and commercial payers have many levers that can significantly shift the interoperability goals and value proposition for health care organizations. Moreover, payment contracts and reporting requirements can set the expectation for data sharing, security, and compliance to standards.
Payers have several motivations to foster digital interoperability through procurement: first and foremost is care quality and value improvement. When clinical and administrative data can flow more effortlessly, governmental and commercial payers can benefit from the reduced cost and redundancy of services, lower rates of patient harm, and greater ability to monitor care quality and outcomes. This may extend beyond the three tiers of interoperability discussed earlier to include telemedicine and beyond. One study by Fallon Health reported a savings of $687 per member per month by adopting a remote monitoring system that allows seniors to safely live in their homes longer while reducing cost of care (Healthsense, 2016).
Secondly, payers currently incur substantial operating costs from maintaining data exchange interfaces with a network of providers that are exchanging data through various record management systems, data formats, and interfaces. A movement toward a common data exchange platform that allows modular add-ons for predictive analytic tools to process multiple streams of data feeds can eliminate the costs of technology integration for many payers.
A third motivation is the pursuit of population health and continuous learning. With the increase in the number of patients with multiple chronic conditions and complex needs, payers should actively partner with providers to advance care delivery and promote health and wellness of high-needs patients. To generate actionable insight, payers need a trusted data exchange framework to securely obtain interoperable clinical and claims data, as well as the ability to add predictive analytic tools on the back end for population health management.
Some commercial and governmental payers already assert influence with regard to health care data interoperability. For example, contractual agreements may include requirement for data sharing, file format and field definitions, privacy and security, and the reporting time frame. Payers can collectively agree on specific interoperability standards and provide specific technical guidance for providers to use in their procurement specifications. Moreover, payers can strategically embed incentives for adopting certified technology capable of sharing information, essentially lowering the cost of adoption for providers with more constrained resources. Payers are also positioned to send a clear signal that elevates the priority to make socio-demographic, behavioral, and other personal data interoperable—so that the care is optimized for “point of life” and not just point of care. Another approach is to explicitly provide incentives for the use of wearable, mobile technology, and telemedicine modules that include remote monitoring. Such information traditionally resides outside of care settings, and there are substantial technical and cultural barriers to integrating them.
Finally, public and commercial payers should actively engage in the formation of a health IT procurement “commons.” They should participate in building shared, national resources for procurement specifications, interoperability and data-sharing quality measurement, testing and certification of plug-and-play technologies, and the recognition of common standards and architecture.
ROLES FOR HEALTH IT VENDORS
Industry leaders often highlight the fact that, although technology to enable interoperability generally exists, until the recent past, market forces have not created sufficient incentives to offer interoperability as a key feature. Even with increasingly aligned market incentives, some companies still view the adoption of open interfaces as detrimental to their current competitive advantage—selling bundled solutions or a system of devices with closed, proprietary interfaces. On the other hand, policy and regulatory mechanisms have been progressively driving vendors to demonstrate, if not compete on, interoperability. This has been the case for the macro-tier under various federal requirements and incentive programs, where providers and EHR vendors have to demonstrate data exchange capabilities with other health care institutions, HIEs, and government agencies. Market forces have also begun to shift focus to value-based payment models that prioritize interoperability at higher levels than what was true in pure fee-for-service settings.
Another major driver of change is the pressing need to mitigate risk exposure associated with cyberbreaches and unsecured technologies. In 2012, the “Internet
of things” was barely on the radar, but today Internet-connected medical infrastructure and medical devices have to be top of mind for security teams.
For medical systems and devices at large, achieving extended, modular connectivity will often require the development of new interfaces or adapters, for which both device makers and providers bear the costs. The collaborative development of an open architecture platform that uses a small number of agreed-upon data exchange standards will require active participation of IT vendors. As seen in other industries, such alignment with other stakeholders is the only way to ensure that health care providers and the system and device manufacturers can both reap the benefit of increased interoperability and adoption of common standards. The transition away from closed, proprietary interfaces may require a shift in tactics in competing for market share in the device industry, but it may prove to diversify product risks and shorten the time from innovation to delivery in settings where good standards exist.
Software platform and application vendors should demonstrate how data captured from external sources can be integrated into clinical workflows, and the value of such integration. Only when these use cases are adequately evaluated and their value widely replicated in multiple settings will providers demand interoperability and open solutions and reward vendors who embrace open-architecture principles.
As EHR systems remain a hub for aggregating the patient care experience and treatment progress, EHR vendors will exert a key influence in the market dynamics and expectations. Health IT system vendors should work together to agree upon the best industry standard exchange specifications and then make them available to their customers. Two recent examples are the CommonWell Health Alliance and Carequality, multivendor collaborations to improve document sharing among the members. Recently, CommonWell and Carequality have agreed to interconnect their networks, furthering the reach of document exchange.
Finally, vendors of patient-connected technologies such as telemedicine modules and wearable technologies should actively engage patients and families in their technology development and improvement while developing a vigorous security and privacy protection framework that respects their data exchange wishes. Established platforms should also contribute to a shared testing infrastructure for device manufacturers and mobile technology innovators to test connectivity with enterprise systems.
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