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?

Your thoughts and comments on this ME-P are appreciated. Feel free to review our top-left column, and top-right sidebar materials, links, URLs and related websites, too. Then, subscribe to the ME-P. It is fast, free and secure.

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18 Responses

  1. Hope, on March 2, 2010 at 6:03 PM said:

    HHS panel considers eHR risks as reports detail injuries and deaths

    Article by Mary Mosquera
    Sunday, February 28, 2010

    While electronic health records are considered key to improving the quality of healthcare – they can also be a risk to patient safety – and government and industry officials are calling for better use practices and possible closer oversight of eHRs by regulatory agencies.

    You heard it first from our thought-leader Sahid N. Shah five years ago, again from the ME-P, and now from the government!

    More: http://www.govhealthit.com/newsitem.aspx?nid=73210

    Hope Rachel Hetico; RN, MHA
    [Managing Editor]

    Like

  2. D. Kellus Pruitt DDS, on March 2, 2010 at 8:18 PM said:

    I find it interesting that the more under-reported issues ME-P uncovers, the faster the ME-P Nation attracts members.

    You are now up to 181,199 members. Congratulations, ME-P. You must be doing something right.

    D. Kellus Pruitt; DDS

    Like

  3. George, on March 6, 2010 at 7:16 PM said:

    Shahid,
    Just remember that the Fed’s SEC also regulated Bernie Madoff.
    George

    Like

  4. Sandy, on March 13, 2010 at 11:57 AM said:

    Shahid, Darrell and George,

    Still, if by improvement of patient care the promise of eMRs is to actually make people’s healthcare better, or truly improve a patient’s health itself, then those claims must be evaluated with a skeptical eye.

    This is similar to the clinical decision making enhancement promises that are often made. Much like clinical decisions, patient care is a very human activity and simply introducing a better regulated [maybe] record keeping system will not improve people’s health.

    Where an improvement in health can occur however is in the tracking of clinical goals and helping patients meet those goals by reminding patients for regular tasks.

    Sandy

    Like

  5. Skeptic, on April 9, 2010 at 10:30 AM said:

    Dear ME-P,

    Yeah, sure! The FDA will regulate eMRs like it does drugs and radiology equipment … just not very well.

    http://www.msnbc.msn.com/id/36274324

    Kinda reminds one of the SEC; doesn’t it?

    A Skeptic

    Like

  6. Donna, on April 13, 2010 at 10:00 AM said:

    Mr. Shah

    It seems that you may be correct. The FDA may indeed get a role in certifying electronic health records because of that agency’s long history of monitoring other products for patient safety.

    http://www.informationweek.com/news/healthcare/EMR/showArticle.jhtml?articleID=224201003

    Donna

    Like

  7. Dan, on April 28, 2010 at 12:13 PM said:

    The Rise and Fall of CPOE

    This shouldn’t surprise veterans of the health IT industry, but a review of FDA reports by the Huffington Post Investigative Fund, and elsewhere, shows that poorly implemented CPOE systems can lead to fatal medical errors.

    http://huffpostfund.org/stories/2010/04/doctors-shift-electronic-health-systems-signs-harm-emerge

    http://www.fiercehealthit.com/story/study-inconsistent-records-cpoe-systems-cause-medication-errors/2009-06-01?utm_medium=nl&utm_source=internal

    Daniel

    Like

  9. Jake, on January 5, 2011 at 12:17 PM said:

    FDA Regulations and m-Health

    The m-Health Regulatory Coalition, an industry group comprised of many of the mobile health IT stakeholders, is weighing in on the issue of when the Food and Drug Administration (FDA) should regulate mobile healthcare hardware and software–and to what degree.

    http://www.fiercemobilehealthcare.com/story/industry-group-questions-fda-oversite-m-health-devices/2011-01-04?utm_medium=nl&utm_source=internal

    Any thoughts?

    Jake

    Like

  10. Paras, on April 26, 2012 at 11:16 AM said:

    FDA Mission Change

    The FDA has a new mission [House Bill Section 601]. But, is it more suited to the Department of Commerce?

    Supposidly, it protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by this Act; (Section 601, page. 143 of the April 23, 2012 version of the House Bill).

    But, to anyone who carefully watches prescription drug policy globally, this provision is striking. It tells the FDA that its mission isn’t just safety, but also “promoting economic growth, innovation, competitiveness, and job creation among the industries regulated” by the FDA.

    In other words, help drug and device companies make more money.

    So, is this a good/terrible policy change which will dramatically overmine/undermine the FDA’s ability to make decisions based only on science and the public’s health?

    Paras

    Like

  11. Wanda, on April 30, 2012 at 9:51 PM said:

    Four Medical Implants That Escaped FDA Scrutiny

    Medical implants like hip replacements and heart valve rings improve the lives of millions of Americans. But, critics say too many risky devices are cleared without FDA approval.

    http://www.propublica.org/special/four-medical-implants-that-escaped-fda-scrutiny

    So, forget about eMRs for now. Any thoughts?

    Wanda

    Like

  12. Amor, on May 3, 2012 at 4:05 PM said:

    Shahid,

    Reclassifying EHRs as medical devices would come at a cost.

    http://www.fierceemr.com/story/protect-medical-devices-cybercrime/2012-04-19

    You seem to be a thought-leader on this topic.

    Amor

    Like

  13. Hadley, on June 11, 2012 at 11:45 PM said:

    Why the Electronic Medical Record Needs to be Viewed as a Medical Device

    Essay on a related topic:

    http://thehealthcareblog.com/blog/2012/06/04/why-the-electronic-medical-record-needs-to-be-viewed-as-a-medical-device/

    Hadley

    Like

  14. Corby, on October 24, 2012 at 11:29 PM said:

    The Coming Storm

    And now … FDA Regulation of Mobile Medical Applications?

    http://thehealthcareblog.com/blog/2012/10/24/a-coming-storm-fda-regulation-of-mobile-medical-applications/

    Corby

    Like

  15. David Jones, on September 17, 2013 at 7:45 PM said:

    Mr. Shah,

    “There’s a gigantic gulf between the tech industry as a whole and the medical regulatory infrastructure”

    David Jones
    [Chairman and Managing Director]
    Chrysalis Ventures
    via Ann Miller RN MHA

    Like

  16. Dr. Singh, on September 23, 2013 at 11:31 PM said:

    FDA final med app guidance based on risk

    As mobile medical apps become more and more like medical devices, the FDA is finalizing plans to regulate them similarly, the agency said on Monday in delivering the eagerly-anticipated guidelines.

    http://www.govhealthit.com/news/fda-med-app-final-guidance-solidifies-risk-based-standards

    Mr. Shah – you are indeed ahead of the curve.

    Dr. Singh

    Like

  17. Hunter, on April 15, 2014 at 9:54 PM said:

    Health IT and the Coming Regulation

    Food and Drug Administration has spent decades refining its processes for approving drugs and devices (and is still refining them), so what would happen if they extended their scope to the exploding health software industry?

    http://thehealthcareblog.com/blog/2014/04/14/the-coming-regulation/

    Hunter

    Like

  18. E. Ray Dorsey, on August 24, 2016 at 7:45 PM said:

    FDA

    “The FDA previously provided guidance on what health “applications” are likely to come under their review, which has helped the industry move forward. If the FDA similarly said we want to see evaluations of new therapeutics that include novel outcome measures, including wearable sensors and smartphone applications that hold the promise of providing objective, sensitive, high-frequency assessments of diseases, that would help the pharmaceutical and medical device industry move forward.”

    E. Ray Dorsey
    [Professor of Neurology]
    Director of the CHET
    University of Rochester Medical Center

    Like

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