As healthcare becomes more digitized and clinical treatments shift away from one-size-fits-all therapies, the industry will need to become more critical about how it’s employing and curating health data.
For vendors and providers, it’s about understanding what tools are at their disposal and how they can be implemented to maintain and improve the standard of care. But for regulators like the FDA, the immediate challenge is bringing together experts to craft health data frameworks and policies that will guide the rest of the industry.
“You can talk about the digital platforms, the Digital Health Center of Excellence, … the data you need to look at, but at the end of the day you need the people with the expertise,” FDA Commissioner Dr. Stephen Hahn said today during a HLTH virtual keynote. “So we’re using our hiring authorities and we’re searching for the expertise, and we’ve made a number of terrific personnel hires to help us in this effort.
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“One of the things that I said was a priority for the agency when I first came there was unleashing the power of data – this is a part of that. It’s not just about those data; it’s about the people who can help us synthesize, gather and interpret those data to make better and more informed decisions.”
Suffice it to say that the agency hasn’t locked in its regulatory strategy regarding healthcare data. Taking a moment to stress the “rapidly evolving and complex environment” of healthcare, Hahn declined to outline any specific issues or changes under review at the agency. Rather, the regulator’s approach will be constant regulatory framework updates and fast-paced adaptation to whatever curveballs the developing field may throw the FDA’s way.
“I mean, I came from the cancer world,” he said. “If you think about the data that’s collected now – genomic data, proteomic data, metabolomic data – on a cancer patient and how that might relate to a potential response, develop a biomarker, etc., those data need to be integrated in a way that can help a doctor make a decision, but they also need to be integrated in a way to help us make the absolute best regulatory decision in the most efficient way possible. So we’re thinking about what our frameworks look like across all of our medical products, and that’s something we think is a high priority.”
Privacy concerns are also on the regulator’s table, with Hahn acknowledging pressures from patients and providers alike to ensure that personal information is not misused. As the agency begins to review more applications for clinical data aggregation algorithms, for example, he said that issues of privacy will be “a top concern” for regulators, and that programs are being launched both inside and outside of the agency that address the need for public confidence in data handling.
To tackle these mounting health data regulation challenges, the FDA will need ample resources and continued support from Washington D.C., Hahn said. The commissioner said that the FDA has already had “a lot of success” working with lawmakers on a few of the agency’s strategic priorities.
Among these was the collection of real-world evidence from manufacturers, claims data and EHRs – an issue that’s receiving particular attention as the FDA prepares to review a bevy of in-development COVID-19 vaccines. Federal support will be “very important” if the agency is to develop the infrastructure and personnel necessary to handle post-marketing assessments of these and countless other treatments or medical devices, Hahn said.
“We’ve been partnering with [Capitol Hill] and the rest of the administration to identify the resources that we need to do that going forward,” he said. “Congress and the administration have been very generous to date, and we really look forward to working with them more in the future to develop that plan into maturity.”
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