The FDA and eMR Regulation?

Posted on March 1, 2010 by Dr. David Edward Marcinko MBA MEd CMP™

One HIT Futurist’s Opinion

By Staff Reporters

A few years ago, Shahid N. Shah wrote that the FDA should be paying closer attention to healthcare IT systems and consider regulating those systems; in other words – regulating them the same as any other drug, medical device or foodstuff.

After all, some healthcare IT systems can kill just as easily as inappropriate medical care.

Link: http://www.healthcareguy.com/2010/02/24/thank-goodness-the-fda-could-start-regulating-healthcare-it-systems/

Our View

We agree that hospital IT systems and eMRs can, do, and will kill when not used or implemented properly.

And, it’s a shame that we may need the government to improve quality; but perhaps the fear of regulation will do the trick. In fact, we’ve also warned of similar adverse unintended consequences of eMRs and related HIT systems, previously on this ME-P.

Link: https://healthcarefinancials.wordpress.com/2009/12/23/will-electronic-records-raise-the-legal-standard-of-care-and-increase-malpractice-risk/#comments

About Shahid Shah

Shahid is CEO of Netspective, a Java/.NET consultancy that specializes in healthcare IT with an emphasis on e-health, EMRs, data integration, and legacy modernization. He is also a valued thought-leader for the ME-P, who will be contributing the HIT chapter for the third edition of our best selling book: www.BusinessofMedicalPractice.com to be released later this Spring.

Conclusion

And so, your thoughts and comments on this ME-Pare appreciated. Should eMRs be regulated by the FDA? Does the FDA need to put even more on its plate and has it done a good job until now? Do we really need more governmental intervention in healthcare?

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