BLOG: The regulation we need
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In health care, regulation is a bit of a dirty word.
Most of us doctors, who are bound to treat our patients ethically and under the standard of care, already have a strict set of obligations. Following those rules has kept the delivery of care mostly pure for hundreds of years. But we are practicing in an era that is transforming because of the rapid development of digital solutions, and we want and need regulation to make these solutions more interoperable.
The regulation of artificial intelligence is a subject I’ll leave for a different day. The digital solutions I’m talking about start with electronic health records systems that were forced upon us more than a decade ago. These systems are the repository for all the information we know about our patients. As I have written before, EHR systems are generally clunky and designed for us to work around their shortcomings rather than the other way around. But EHR systems do work, and most of us who are old enough to know the difference would not go back to paper records because we no longer must get by with missing charts.
But digital solutions go far beyond EHRs, of course. We now have an ecosystem of startup companies that offer services for improved patient communication, automated image analysis, surgical planning, streamlining of workflow and supply chain, and far more. As diverse as these systems and their offerings are, the one challenge every system faces is the ability to extract data from EHR systems and then to insert other data back in.
When I started the software company MDbackline about 10 years ago, EHRs were fairly new, and so was the idea to have an external plug-in software solution to help us be better doctors. MDbackline, which was acquired last year by Alcon, was designed to streamline patient communications, helping them better prepare for visits and give us structured feedback on their treatments. The problem was that everything the software did relied on reading patient data from EHRs and inserting other data back in.
You would think that over 10 years it would become easier to extract and insert data in EHR systems. It hasn’t. Doing just that remains one of the biggest challenges every health care tech company faces today.
Why is this so difficult? First, there is little immediate gain for EHR companies in helping an unrelated software vendor with connectivity. Any desire they have to please their customers with better functionality is more than overcome by the fear that smaller vendors may jeopardize security, insert corruption or otherwise compromise performance of the EHR platform. This lack of support causes startups to languish, and this stifles innovation that would otherwise advance patient care.
We need a standard by which EHR vendors can earn an “interoperability certified” label that denotes an ability to plug in outside solutions for easy data interchange. EHR vendors should pay for the cost of audits to verify their own certification, much as physicians must pay for their own periodic board recertification.
The biggest challenge here would likely be agreeing on and implementing standards for certification that would serve most stakeholders (clinicians and startups). But standards like DICOM do exist, and there is strong support from both FDA and NIH for interoperability standards to be enforced. I just hope it won’t take them another 10 years to get it done.
Follow @DrHovanesian on X, formerly known as Twitter.
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