Building on the Robert Wood Johnson Foundation’s idea to incorporate data from beyond healthcare, the ONC is hoping to lay the groundwork for an “EHR of the future” that includes a wide swath of data that it said could more accurately capture a person’s overall health.
In a lengthy report released this week, in conjunction with the foundation and the JASON Group, an independent group of scientists and academics that advises the U.S. government on science and technology, officials detail the lofty goal of “health, rather than healthcare,” along with the need for access to data and the so-far elusive wish of interoperability.
“…It will become necessary to expand greatly the types of data that can be ingested and analyzed,” the report states. “ In addition to the traditional data associated with health care (e.g., EHR data), it will also be necessary to assimilate data from PHRs. These include, for example, data from personal health devices, patient collaborative networks, social media, environmental and demographic data, and the burgeoning data streams that will soon become available through progress in genomics and other ‘omics.’”
Yet physicians have largely said that, while they’re not opposed to incorporating new data stream, such as wearables, simply adding more data from so many different sources will overwhelm health systems, and it’s likely to be a daunting challenge.
The report acknowledges the difficulty but says progress has been made to better incorporate the new data streams, saying “the requirement for interoperability through the adoption of open APIs becomes even more critical here; without this interoperability it will be extremely difficult to scale up today’s health information technology systems to assimilate and analyze these new data sources.”
The expansion of APIs is especially important when it comes to the use of smartphones, but “there remains a critical need for open APIs for EHR systems to further open the entrepreneurial space,” the report said.
With wearable devices specifically, the challenges are many, but so, too, are the promises.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“Whereas these devices may have a promising future for informing health assessment and treatments, there are several practices that inhibit or limit such use,” the report said. “Data from these devices are not yet adequate to draw detailed comparisons between individuals or against a population, except for a limited number of specific activities, such as sleeping. The devices are able to provide coarse-grained activity monitoring, such as assessing whether an individual is sedentary, sleeping, or active, and are able to make relative comparisons of a single individual at different times”
The report urges three key strategies in overcoming data sharing challenges: including groups that focus on specific medical conditions, such as the American Heart Association; the need to improve data exchange between members of a person’s healthcare team; and developing reliable indices of the health of a community, based on both geographic and socioeconomic indicators.
The report also calls for a “nimble regulatory environment,” calling specific attention to the FDA’s single nucleotide polymorphisms data. The regulatory agency has kept that data, which can be linked to the potential occurrence of certain diseases, away from patients, saying it falls into the space of medical diagnosis and not patient education.
“Such data streams, provided they are accurately measured and reported, are relevant to medical diagnosis and prognosis, but it would also be desirable to allow consumers to continue to make use of such services, and, importantly, to provide mechanisms by which this information could be shared with the consumer’s health care team for appropriate medical interpretation,” the report said.
The report includes a litany of recommendations, among them:
— HHS should adopt standards and policies for sharing data
— Further support for policies proposing open API standards for EHR vendors and support for reimbursement differentials for institutions that adopt “ecosystem-friendly” EHRs
— “Race to the top” challenges that seek to demonstrate a “measurable increase in health and wellness and a concomitant reduction in the number of encounters with the healthcare system.”
— The inclusion of relevant nonprofits and their “stamps of approval” for apps and other consumer tools.
— Accrediting bodies requiring training of all healthcare team members to achieve fluency in a common parlance of health informatics.
— Nuanced approaches from regulatory agencies. “Products and services that now risk being construed as ‘practicing medicine’ could be allowed to exist in a more nimble regulatory space that fosters more innovation… while mitigating concerns over demonstrated accuracy.”
Given that “most healthcare doesn’t occur in medical centers,” the report said the healthcare system as a whole should shift its attention to a broader setting that includes more data from personal devices.
“It is clear that only a small fraction of individuals with health issues visit a physician, only 1% are hospitalized, and less than 0.1% are hospitalized in an academic medical research center. Some argue that current investments in health care are inconsistent with this reality,” the report said.
In addition, “current health care research and investments do not adequately address the role played by social determinants in health and wellness,” according to the report. As such, the broadening of the EHR “ can best be enabled through the development and implementation of a robust health data infrastructure, one which is able to integrate and interact with data beyond the current electronic health records.”
