ORLANDO – It's going to take more than tech-first approaches to achieve the quadruple aim, and despite intense focus on how to leverage and safeguard artificial intelligence to enhance care delivery – the topic du jour – AI is only one element of the digital health universe.

"There is enormous promise from the digitization of healthcare, but digital is not a silver bullet," said Jennifer Goldsack, founder and chief executive officer of the Digital Medicine Society, as she opened a panel session diving into real-world challenges facing digital health innovation at HIMSS24 on Wednesday.

"We have to keep the promise of innovation for the lives of patients at the forefront of our sort of psyche as we approach all of this," she said.

Joining her for the conversation is Dr. Sandeep Wadhwa, the global chief medical officer for 3M Health Information Systems, Samir Jain, senior director of product management at Medidata Solutions, and Kathleen Aller, head of global healthcare market strategy for InterSystems.

Linking longitudinal records

Thinking through clinical logic to improve patient data generation and streamline billing is not only about getting it right, "the other part of that is, what's the outcome of the care?" said Wadhwa.

The CMO said that he thinks the industry is in a better position to link longitudinal records to events and promote accountability, "not just for the care that's being delivered at the moment, but the outcome of that care over time."

"Now we actually have the ability to do that longitudinal tracking to outcome measures," Goldsack added.

"What I'm appreciating is the complexity of healthcare, particularly as it's moving to lower-acuity settings of care," said Wadhwa. "With more and more complex care taking place outside of hospital settings, it’s an opportunity."

He noted that some outcomes of interest – lower morbidity and lower mortality, for example – are much harder to measure.

"But I really think there's an opportunity with digitization and linking of records to bring a safety-first movement for care that's routinely delivered," Wadhwa said.

Broader patient monitoring

"The analog of moving care from kind of a centralized location into more of an outpatient clinic – we see that in clinical research as well," Jain said.

While sponsors want to be able to see data in the format that they require for their U.S. Food and Drug Administration submissions, "they really need to understand adverse events for those patients and have a more complete picture of what is happening with the patient outside of just the normal course of the clinical trial," he said.

Researchers must be able to see whether their drug is effective or if patients are experiencing adverse events.

"So that safety, and that kind of broader patient monitoring, becomes incredibly impactful," said Jain.

Bridging the gap between care and research can make it more efficient for both clinical researchers and patients, and can help improve care outcomes, according to Jain.

"When you think about a patient with a rare disease, where clinical research is the only care option that they have, at this point, the ability to get that drug to market quicker is lifesaving," he said.

While that is the greatest impact seen in drug development, there’s a "huge movement towards synthetic control arms," Jain continued.

In clinical trials, 50% of the time a patient is going to get a placebo, and if the patient is participating in the research to save their life, they "kind of really don't want that placebo," he said.

"From an ethics perspective, what we can do with the increase in data that we have is to be able to shrink those control arms in a trial to maybe 5% of the patient population, or 10%," and delivering "therapies earlier on in the process to patients that might end up saving their lives."

FHIR, flow and trust

Aller added that an exciting development from a digital health perspective is the work that the FDA, eHealthExchange and  Intersystems are doing through Project BEST to automate adverse drug-reporting after the drug goes to market.

"Right now, it's a very manual process, as with data collection for clinical research. But what they're doing is they're leveraging FHIR" and the qualified health information network brokering data under TEFCA "to push the data directly to the FDA," she said.

That allows electronic health records to be queried.

"A drug may make it to market, it may get through all those trials, but then sometimes there are things that happen in the real world that you didn't expect, and we want to know those right away and have the ability to alert patients and alert the public, if they need to be," she said.

Another area where data interoperability could dramatically lower costs is on performance measures, for which payers and providers are both "mutually on the hook," said Aller.

They need to deliver data on what they're being measured on.

"That's a heck of a lot of work, and it's similar to the work that you have to do to populate your clinical trial data," she said to Jain.

"If you brought that data together in a longitudinal record, you can review that, you can automate that process," she said.

While the cost will not go away entirely, "you're going to make it go down on both sides," and the data can be managed throughout the year – not just at year-end end.

"So then you've not only improved your performance measurement, because you've captured missing data along the way, but you brought down the cost of doing that, and that's huge," she said.

Interoperability investments are high in the payer community, with new federal mandates around prior authorization and information blocking rules.

"One of the people we were speaking with, who's doing some really pioneering work exchanging data with the provider organizations in his network, has commented that it's not the technical issues that get them, it's all the negotiations around the data use agreement, around the liability, around the protections and the contracts, and not the technical things," she said.

"But it's building that trust."

With the healthcare ecosystem reeling from the Change Healthcare ransomware attack on February 21, "I think that bar is going to go up even higher now, and I'm going to be interested to see what it does in terms of the conversation around this new interoperability," said Aller. 

Update: This article was updated on March 15, 2024 to include the name and link to Project BEST.

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.