Realizing the Value (and Profitability) of Digital Health Data

As clinicians click and tap at their electronic health records (EHRs), they may be unaware that they are fueling a huge public and private enterprise that will turn their patients' digitized health data into enormously valuableand potentially profitablenew products. All those patient reports, physical findings, problem lists, medication lists, and laboratory and imaging tests will not remain confined on local servers forever. Instead, once ethical, technical, and legal issues are resolved, those data will be sucked into cloud-based test beds, where machine learning and artificial intelligence will refine them into software algorithms that create vast new clinical capabilities. For the first time in human history, the global clinical experience of the health professions and their patients will be available to examine and repurpose in nearly real time to make clinicians smarter and people healthier; this all starts humbly with a harried health professional, a keyboard, and a patient. The process of transforming raw electronic data into useful clinical products is neither straightforward nor inexpensive. Technologists, legislators, and lawyers must find ways to protect patients' rights to their own information as well as their privacy and security. Technical methods for standardizing, aggregating, searching, and exchanging data must be improved. Machine learning and artificial intelligence are in their infancy. New algorithms must be validated in clinical experiments and then integrated into EHRs for daily application. Government likely will fund some of the work creating these new information capabilities. For example, the federal government's precision medicine initiative envisions mining EHR data to achieve its goals. The National Institutes of Health likely will fund considerable research using electronic clinical information to improve care for patients whose conditions fall within its disease-specific mandates. Private industry also will play an important role in developing and distributing the data-based products of our new digital health age. Evidence of industry interest in the digital health economy already is apparent. According to one source (1), venture capital investments in digital health grew at a compound annual rate of 30% from 2011 to 2016 and last year totaled $4.2 billion. Large existing companiesincluding Apple, Microsoft, IBM, Alphabet (Google's parent), Merck, Aetna, and UnitedHealth Group (through its Optum subsidiary)also are investing in digital health products (24). Because these investments are proprietary, their precise nature is uncertain. Developers of EHRs also may enter this market, because they currently are the custodians of major data pools and must be involved in integrating any new tools with existing EHRs. In addition, some non- and for-profit health care delivery systems likely will create products based on their own data warehouses. Academic health centers, with their deep benches of talented, computer-savvy young physicians, are well-positioned to spin off software companies that turn EHR data into useful clinical tools. One way to think about the troves of digital health data now accumulating is as a new natural resource. To be useful, that resource must be extracted, transported, and refined. In the United States, we typically leave it to the private sector to exploit such resources. Private industry then recoups its investment plus a profit through sales in private markets. The same pattern likely will prevail in the digital health sector. At the same time, the new digital health resources have unique attributes that must be addressed if we are to allow private markets to commercialize and distribute the resulting products. First, electronic health data are created not by anonymous physical forces but by human effortin this case, the work of frontline clinicians. The federal Health Information Technology for Economic and Clinical Health (HITECH) Act rewarded some health professionals and hospitals for installing EHRs and accomplishing their meaningful use. Incentives under the Medicare and CHIP (Children's Health Insurance Program) Reauthorization Act of 2016 (MACRA) continue to provide modest financial benefits for physicians who record and share their patients' clinical information electronically (5). However, whether these programs adequately compensate individual clinicians for the extra time and effort required to use existing EHRs is doubtful, especially given the limitations of those tools. This situation creates a problem that economists would label a positive externality. The work of clinicians is creating value from which many stakeholders, including both the general public and a raft of new and existing for-profit industries, likely will benefit. Clinicians themselves, however, reap minimal rewards, except for the hope of improving their patients' care at some future time. Indeed, this imbalance between benefit and burden underlies the discontent of many clinicians. That discontent might be addressed partly by increasing the usability of the EHRs, but the benefitburden imbalance would remain. A second distinction between the growing store of digital health information and other natural resources is the involvement of millionsperhaps billionsof patients in generating electronic data. To some degree, all those patients have an ownership stake in this new digital opportunity. How, or whether, to compensate them is uncertain but must be considered. With proper protections, many probably would contribute their personal data willingly without any compensation other than the gratification they receive from furthering the welfare of humankind. Yet, at a minimum, they must consent to surrendering their information, understand its future uses, and recognize that others may profit financially from it. Third, the process of sharing clinical data creates risks for patients that are unlike those encountered with the exploitation of other resources. In the Internet age, making electronic patient records completely anonymous is extremely difficult, so sharing even deidentified files carries a small but finite risk that patient privacy will be compromised. In addition, before those data are deidentified for the purpose of sharing with outside parties, patients' electronic information is subject to privacy and security threats that can never be totally eliminated. Obtaining informed consent when the data are collected may address this issue, but the process of acquiring consent has costs that, once again, are borne primarily by clinicians, health care organizations, and patients at the front lines. Fourthand here the analogy to exploiting natural resources has strong parallelsthe exploitation of new data pools likely will have unanticipated effects, some positive but others negative. For example, as new information-based products appear on the market, some will be useful but others may be less so. Some may even be harmful. The need to protect consumers from poorly designed, unsafe, invalid, or even fraudulent new electronic health products will inevitably create the need for new regulatory regimes. With every new technologic opportunity, problems arise. The special circumstances associated with the creation of a vast new pool of electronic patient information must be addressed so that all parties contributing to this unparalleled resource are treated fairly and the risks of exploiting this new resource and those who create it are minimized.