What innovation has there been in the past ten years that would have been killed by regulation?

oldMster: Similar to S Silverstein, I am a former Engineering Mgr for a Medical Device/Software company and now I’m a PM for a multiple hospital medical center in Healthcare IT.

With those experiences, I’ve noted that there are both blessings and challenges in developing and deploying Medical Software when regulated by the FDA (Medical Device) and in the Hospital as a Healthcare IT worker where my client is regulated by JCAHO. I assure you there is no one environment that is perfect for the software developer/deployer.

I can also assure you that regulation *alone* is not the answer, something we are dealing with recent focus in the current Obama administration in our industry. While some are thrilled that there has never been a greater demand for our IT “services”, I’m concerned about the sustainability of the current pace of regulation and consequential hiring of people into this area to process and operationalize said regulation. This may add some value, but it adds a huge cost as well.

The FDA is already overwhelmed with the responsibilities it has to enforce the Quality System Regulation (QSR) with respect to Class I / Class II devices involving a software component. I’m not sure why we would think a Federal government administration can suddenly create a whole new regulatory environment that controls how we Healthcare IT workers use software in hospitals can regulate us better than we do ourselves.

I’m *very* supportive of regulation and governing bodies to hold us accountable. That said, the best examples of regulation I saw during my time at a Medical Device company was seen in the option we exercised in choosing a governing body to audit our compliance to standards set to allow us to distribute product to Europe (under the CE, EN46001, aka ISO9001 harmonized standards). That the FDA adopted this same standards under the Quality System Regulation (QSR) suggests the government *did* understand this. I question if the current government has that same intention in Healthcare IT should they proceed on our current trajectory.

In the end, the best regulation is self-regulation. Any other type of regulation though useful to some extent in creating stiff penalties to those it punishes for misbehavior, it also carries with it increased costs and inefficiencies that may very well make healthcare both less affordable as well as less effective.

Call to Government and Healthcare Leaders: Let us proceed cautiously and in partnerhsip with one another and seek a *balanced solution* that holds us accountabile without killing innovation in this Healthcare IT field we all cherish and benefit from. Our caregivers and patients are counting on us!