It got in the door with electronic medical records, and has recently received a facelift under the term evidence-based medicine.
We are told that CDS or EBM is becoming fine-tuned and energized through powerful analytics that pick up the increasing number of patient and public health data sets out in the field. Most experts reaffirm that the final word lies with the physician that each patient is unique, and thus no canned set of rules can substitute for the care that the physician must give to a patient’s particular conditions and the sustained attention that the physician must give to the effects of treatment. Still, when the industry gives a platform to futurists such as Vinod Khosla who suggest that CDS can become more reliable than a physician’s judgment, we have to start demanding a lot more reliability from the computer. Traditionally, it was based on the results of randomized, double-blind clinical trials.
These can turn up excellent nuggets of unexpected impacts such as Vioxx’s famous fatalities but suffer also from the biases of the researches designing the algorithms, difficulties collecting accurate data, the risk of making invalid correlations, and the risk of inappropriately attributing causation. So, there are clear and present justifications for demanding that CDS vendors demonstrate its reliability. CDS, like other aspects of the electronic health records into which it is embedded, has never been regulated or subjected to public safety tests and audits. The argument trotted out by EHR vendors like every industry when opposing regulation is that it will slow down innovation.
In an industry that people can’t trust, regulation can provide a firm floor on which a new market can be built, and the assurance that CDS is working properly can open up the space for companies to do more of it and charge for it. Still, there seems to be a pendulum swing away from regulation at present. The FDA has never regulated electronic health records as it has other medical software, and has been carving out classes of medical devices that require little oversight. When it took up EHR safety last year, the FDA asked merely for vendors to participate voluntarily in a safety centre.
The prerequisite for gauging CDS’s reliability is transparency. The vendor must specify which studies, or analytics and data sets, went into the recommendation process. These fundamentals are just the start of the medical industry’s responsibilities. Finally, an independent service has to collect reports of CDS failures and make them public, like the FDA Adverse Event Reporting System for drugs, and the FDA’s Manufacturer and User Facility Device Experience for medical devices.
What the requirements can do, though, is put CDS on the scientific basis it never has had, and push forward the industry more than any big data can do.
Ref: https://www.healthcareittoday.com/2015/01/26/clinical-decision-support-should-be-open-source/
