Patients should be able to get their health data as easily as their tunes on Spotify, but Apple, Google, and other tech giants are impatiently waiting for federal rules that guide how companies can seamlessly swap information.
Tech companies anxious to dive into the world of health apps want the Department of Health and Human Services to hurry up and release the overdue rules for sharing the data that would make those applications work—even if the rules aren’t perfect.
The rules, languishing at the White House since last fall, are a starting point and will consistently improve, Morgan Reed, president of ACT, an association of app makers, said. Technology companies and medical providers simply need to know how the government wants the data to be shared, he said.
The material, known as the interoperability rule, is meant to give patients free access to their health information and prevent providers and health tech vendors from improperly sharing or withholding the data. The rules are vital for companies like Google, which faced backlash in 2019 over concerns that its Ascension health system partnership meant the data giant would have access to millions of patients’ data.
Impatient insurers, technology companies, patient advocates, and even former federal regulators went straight to the White House and HHS’ gates in January to make their case for acting sooner.
“At this time, everything is being written in the hypothetical,” Reed said. “But there has to be a sharpening stone that we can work against to figure out what’s working and what isn’t. And without some kind of point to test our assumptions against, we’ll be continually trapped in this hypothetical world.”
A fast and secure channel between apps that helps providers and patients exchange sensitive health data such as addresses, names, and treatments—also known as an application programming interface (API)—topped the health tech power players’ priorities. The data standard that would help this medium swap electronic information seamlessly, though, is up in the air and not everyone agrees on how that should look.
Adopting the New
IT developers need to build app interfaces that easily allow electronic health information to be accessed, exchanged, and used, the HHS’s health information technology office said in the proposal.
In that vein, the Office of the National Coordinator for Health Information Technology proposed that IT creators meet an updated standard for sharing data between health-care organizations, patients, and app developers. Switching to the fourth version of the updated standard, known as Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR), will take time and money, making some IT companies wary. Many companies still rely on older versions of the standard for their products.
“We agree that FHIR is the next generation of interoperability. However, FHIR is not widely adopted today,” Linda Van Horn, president and CEO of iShare Medical, which provides systems to share patient records, said in a letter to the ONC. “The FHIR standard is moving quickly and will become the next standard, but please give the industry time to implement this standard.”
The ONC has previously said that medical professionals will get two years to prepare before the rule takes effect.
That will allow for feedback on what works and what doesn’t if the ONC is open to that, Brian Scarpelli, ACT’s senior policy counsel, said.
“Inevitably, there’s going to be a need to revisit the rules, even if the outcome of future public consultation, whether it be five or 10 years from now, is that there’s nothing that needs to change, which seems unlikely,” he said.
‘It Should Be That Simple’
Implementing app interfaces received overwhelming support from the health technology industry—as long as it’s simple.
“Think about how hard it is to download any app that you have on your phone. It’s not hard,” Jeffery Smith, vice president of public policy at the American Medical Informatics Association, said.
“Consumers go to the Apple or Google Play store and install. That is downloading without special effort, which is ONC’s entire idea around APIs. Whoever is going to use it doesn’t need to have an expert level of knowledge for health data access. So, the industry is looking at it like if you could use this API for Spotify, then you should be able to for patient access apps. It should be that simple,” he added.
Former ONC officials agree, urging for the rules to be released sooner rather than later in a letter to HHS.
David Blumenthal, president of the Commonwealth Fund and former ONC chief, said the regulations around easy and electronic data exchange are important for consistency in the industry.
“Patients have an absolute right now to their data electronically,” Blumenthal said. “At this point, if you’re in the business in trying to block this process, you’re on the wrong side of history. So, all you can do if you oppose is delay. This is going to happen, and eventually you’ll have to get in line.”