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Mark Dolan's avatar

Congratulations on the Conference -- hope you enjoyed presenting and learning. Solutions to inter-operability and compliance are challenging. I would imagine healthcare is so fragmented, it is not easy. Years ago I worked at a startup. We were contracted by a major hospital system in Boston (Brigham Women's) to implement a system for them. It's function does not matter. What was clear at the time was it was the wild west and Hospital systems could do whatever they please. Great for us. We did our best. We made money. We resold the solution to others. Utterly ridiculous when I think about the consequences of our design. When I contemplate what we built, it seems inevitable our product, operating in isolation could easily kill people.

The larger vendors (Epic, Oracle, etal) take advantage of this fragmentation to get lock-in. Successful regulation and compliance exists and it seems to me it always follows from compliance. The Underwriters Laboratory (UL) listing process, the National Electric Code (NEC) and Request for Comment (RFC) systems are all great examples. None of my examples are mysterious. They are SIMPLY mandated cooperation at the lowest level. All of my examples happen to be thanks to the Institute of Electrical and Electronic Engineers (IEEE). Regulations and standards should be the price of entry into markets which can impact us directly. Standards are a sensible means to endear trust.

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Naveen Agarwal, Ph.D.'s avatar

Excellent article Stephanie. We are watching this play out in real time in the medical device industry. The new medical device regulation in the EU (EU-MDR) is creating a lot more chaos than necessary in the name of safety.

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