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Precision Medicine Initiative Work by Health IT Agency Slowed Due to Limited Funding


NEW YORK (GenomeWeb) – With no 2016 funding under the Precision Medicine Initiative, the Office of the National Coordinator for Health Information Technology (ONC) has been able to partner with the National Institutes of Health and other federal bodies to identify existing interoperability and privacy standards that will be useful when participants donate data already in their electronic health records to the project.

However, the lack of PMI-related funding for ONC, if maintained in 2017, will slow down the office's ability to promulgate new guidelines for bringing in data that's not typically in EHRs, such as genomic information, and advance policies quickly to address privacy issues that come up as the PMI progresses.

The PMI, launched last year, aims to accelerate research into diseases and personalized treatments by drawing on the medical, genomic, and environmental data of 1 million Americans. In his FY2016 budget, President Obama had asked the US Congress to appropriate $215M for the PMI — $200 million for the NIH to assemble the PMI Cohort; $10 million for the FDA to establish curated databases and regulations to advance precision medicine; and $5 million for the ONC to develop interoperability standards that enable the secure exchange of data between systems and policies to protect the privacy of participants. 

Congress ended up giving the NIH the $200M, but okayed only $2.4 million for the FDA and gave nothing to the ONC. Regardless, the ONC has been able to engage with the NIH to further the PMI, according to Jon White, deputy national coordinator for health information technology at the office.

In FY2016, ONC's overall budget is $92 million, which is $32 million more than the previous fiscal year. As such, salaries are taken care of, White noted, and ONC staff members have been able to partake in PMI workshops and collaborate on funding opportunities with the NIH.

"So, in terms of peoples' time, we've been able to continue to be a partner for NIH and give them advice about health IT systems as they exist now, what their capabilities are, where we see best technical practices, and things in development we think they can use," White told GenomeWeb.

He highlighted, for example, that the ONC helped link NIH with health IT developers in the private sector, such as Epic, Cerner, McKesson, and Athenahealth. The NIH said earlier this year that several of these health IT companies will participate in a pilot program called Sync for Science, in which the firms committed to using open, standardized applications that will allow individuals to manage their health data and, should they choose so, donate it to research and the PMI. 

ONC staff members have also worked with the White House's Office of Science and Technology Policy, the Office of Civil Rights, and the National Institute of Standards and Technology (NIST) to develop best principles for securely advancing precision medicine projects. White added that ONC is also working on an implementation guidance with NIST.

ONC has a Precision Medicine Task Force, which has the responsibility of identifying and recommending existing standards that can currently support the PMI, identify standards that can be applied to the initiative after pilot testing, and pinpoint data standard gaps. At a September meeting, the members identified a number of existing standards that are ripe for use within the PMI, such as those ONC has put forth through the Interoperability Standards Advisory

The existing standards identified by the task force have been "baked into NIH funding opportunities," White said, explaining that groups competing for these funds had to discuss in their applications how they planned to apply these standards to the data being collected for the PMI.

There is a lot of substantive policy work to be done and frankly, new questions come up as the science and infrastructure develops.

At its meetings, the Precision Medicine Task Force has discussed genomic data standards to some extent. For example, at the September meeting, the task force flagged the work of the Institute of Medicine's Roundtable on Genomics and Precision Health, and discussed collaborating with the Global Alliance for Genomics and Health — an international coalition of around 400 organizations building common tools for securely sharing genomics and clinical data within a federated system. 

At the latest meeting in May, ONC task force co-chairs Leslie Hall and Andy Wiesenthal noted in a slide presentation that although ONC's focus to date has been on bringing data into the PMI from EHRs, in 2017 and 2018, the group will focus on enabling data gathering from other systems at labs, pharmacy benefit managers, and retail pharmacies. According to the presentation, the task force plans to specifically address genomic data standards, but this was "not for short-term consideration." 

The lack of PMI funding, however, has limited ONC's ability to pilot promising data standards and develop new policies on data privacy, according to White. "We're going to need [these] to develop new knowledge through the PMI," he said, noting, for example, that there are gaps in standards for genomic data and social determinants of health. "Until the private sector is able to fill in and develop standards for that kind of data that can be brought into PMI, new knowledge about those kinds of data is going to lag behind."

In the near term, using existing standards recommended by ONC, healthcare provider organizations submitting data on behalf of volunteers will be able to contribute data that already exists within their EHRs, such as demographic data, information on medications, and outcomes. But genomic data, if those are in patients' EHRs at all, are reported in unstructured and non-standardized formats, such as free text notes and scanned PDFs. This type of information cannot be analyzed using "big data techniques" for links between genetic information and health outcomes, White explained.

Data from genomic tests reside within databases owned by labs performing testing, and aren't always standardized. "The bottom line is, those data aren't available in electronic health records and will have to come from other places," he added. "They're going to come in, initially, in un-standardized ways."

Without additonal funding to carry out its PMI responsibilities, ONC will be hamstrung when it comes to involving other stakeholders, such as genetic testing labs, into pilot efforts.

"It's not a huge amount of funding, considering the scale you get out of it," White said. "But beyond a small group of people who have the time and the resources to voluntarily participate in these things, other folks important to that ecosystem but don't have time and resources can't [participate] because we can't provide them additional funding to be able to do that."

Back in February, with the launch of NIH's Sync for Science project, health IT developers — Allscripts, athenahealth, Cerner, Drchrono, Epic, and McKesson — volunteered to implement a common application programming interface (API) developed by Harvard Medical School's biomedical informatics department, which participants will be able to use to donate information, such as their medications and demographics as defined by ONC

But additional funding will be needed to expand these types of pilots, so a variety of data points can be brought in from more than 1 million participants. "Often when you try to pilot these on a larger scale, when you say 'great we made it work once, but how do you make it work 10 times, a 100 times, a 1,000 times or a 100,000 times?' that's where the funding goes," White observed.

ONC, also tasked with addressing data privacy and security issues within PMI, has been working with the Office of Civil Rights, which administers healthcare data confidentiality laws under the Health Insurance Portability and Accountability Act and the Genetic Information Non-Discrimination Act. But, White noted, ONC doesn't have the capacity to develop additional guidance on privacy issues or respond quickly to new issues that come up as the PMI advances.

"We can give staff level advice," White said. "But there is a lot of substantive policy work to be done and frankly, new questions come up as the science and infrastructure develops."

In FY2017, Obama has requested $309 million for the PMI. If approved by Congress, the NIH would see more than a $100 million increase over its FY2016 allowance for the initiative; the FDA would get $4 million; and the ONC would receive $5 million.

If the funds Obama is asking for come through, "we'll be able to accelerate these efforts years ahead of what they would be if we let them happen on their own, basically when the business case drives them, as opposed to the science driving it," White said, noting that the PMI is "about the science driving access to the data."