By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    How Not to Become a Victim of Medical Scams
    How Not to Become a Victim of Medical Scams
    December 22, 2021
    11 Ways You Can Care for Your Elder Family Members Health
    11 Ways You Can Care for Your Elder Family Members Health
    April 6, 2022
    How Can Brain Injury Lead To Dangerous Long-Term Effects?
    How Can Brain Injury Lead To Dangerous Long-Term Effects?
    August 30, 2022
    Latest News
    7 Most Common Healthcare Accreditation Programs: Which Should You Use?
    August 20, 2025
    Hospital Pest Control and the Fight Against Superbugs
    August 20, 2025
    Hygiene Beyond The Clinic: Attention To Overlooked Non-Clinical Spaces
    August 13, 2025
    5 Steps to a Promising Career as a Healthcare Administrator
    August 3, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    health suppliments
    Experience Life in a Better Way by Experimenting with Supplements!
    November 15, 2022
    Are There Differences in Medicare Spending Across States?
    September 9, 2017
    Obama: Ryan’s Ideas Are Too Radical Unless They’re Also My Ideas
    April 21, 2011
    Latest News
    How Social Security Disability Shapes Access to Care and Everyday Health
    August 22, 2025
    How a DUI Lawyer Can Help When Your Future Health Feels Uncertain
    August 22, 2025
    How One Fall Can Lead to a Long Road of Medical Complications
    August 22, 2025
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: The Case for Regulating EMRs and the New FDA MDDS Rules
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > eHealth > Medical Records > The Case for Regulating EMRs and the New FDA MDDS Rules
Medical RecordsPolicy & Law

The Case for Regulating EMRs and the New FDA MDDS Rules

ShahidShah
ShahidShah
Share
4 Min Read
SHARE

My friend Tim Gee has two great posts covering a couple of very important and timely topics. If you haven’t seen them, check out the following: The Case for Regulating EMRs In this article, Tim articulated the following:

In testimony at the Health and Human Services’ Health Information Technology Policy Committee, Adoption/Certification Workshop held on February 25, 2010, CDRH Director, Jeffrey Shuren, gently articulated FDA’s intent to regulate EMR applications. He reiterated FDA’s legal and regulatory authority over medical device software, safety issues that have been reported to FDA regarding the safety of EMR software, and possible approaches the FDA could take to improve and ensure patient safety moving forward.

Most of us don’t believe that FDA regulation of EHRs is right around the corner but it certainly may not be that far off. The case that Tim makes in his article is pretty compelling and likely to be followed by FDA soon because patient safety is a legitimate concern in EHR. Given how much ONC is pushing EHRs (through Meaningful Use) EHR regulation will be put off a few years but as soon as we see EHRs more commonly used then we’ll see the FDA jumping in faster. Tim explains the current state of affairs pretty well:

Being unregulated, the HIT industry takes a somewhat casual approach to product development. It is common practice for software to be developed without fully documented or complete requirements. And there is often little or no traceability between requirements and testing of the final product. Post-market surveillance of HIT software rarely extends beyond tracking the average time required to close out a service request. These practices have considerable impact on software quality. The QSR specifies that requirements must be complete and fully documented prior to beginning the design phase. And every requirement must be linked to a specific verification test to ensure the design implements that requirement accurately and reliably. Corrective Actions and Preventive Actions (CAPA) are also a part of the QSR, and define a process for investigating customer complaints (i.e, customer calls for support to the vendor) in an effort to identify latent design defects.

FDA Signals Enforcement with Final Medical Device Data systems (MDDS) Rule. Tim’s other posting is about the FDA’s new MDDS rule:

On February 14, 2011 the FDA published notice of the long awaited final rule for medical device data systems (MDDS). The real news behind the final MDDS rule is not the less-burdensome path to market trumpeted by many news stories, but the FDA’s stated intent to exercise “enforcement discretion” with regard to those who create MDDS. For the MDDS vendors who are already regulated (Capsule Tech, Cardiopulmonary Corp, Dawning Technologies and others) this final rule is an easing of the regulatory burden. For those that aren’t (e.g., Bridge-Tech Medical, CareTrends, iSirona, Cerner and others – I currently track 16 companies in the MDDS category) this final rule signals that FDA enforcement actions will be forthcoming for manufacturers that don’t meet FDA’s implementation deadlines (more on that later).

If you’re a heath IT vendor and not doing any device data integration today the ruling above is probably not very applicable to you; however, even if you’re not capturing such data today it’s possible you’ll be integrating with such devices in the future and you may want to perform analytics on or even provide MDDS features. Keep an eye on this rule.

More Read

FDA Avastin Hearing — live blogging
Time for Higher Income Seniors to Pay More for Medicare
The New Scapegoat: Blame It On ObamaCare
Who Leads Whom?
Prescription Drug Abuse in Teens
TAGGED:EMRFDAgovernment
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

travel nurse in north carolina
Balancing Speed and Scope: Choosing the Nursing Degree That Fits Your Goals
Nursing
September 1, 2025
intimacy
How to Keep Intimacy Comfortable as You Age
Relationship and Lifestyle Senior Care
September 1, 2025
engineer fitting prosthetic arm
How Social Security Disability Shapes Access to Care and Everyday Health
Health care
August 20, 2025
a woman explaining the document
How a DUI Lawyer Can Help When Your Future Health Feels Uncertain
Public Health
August 20, 2025

You Might also Like

Medical Education

Better Bedside Manners Heal Doctor-Patient Relationships

July 30, 2012
sleep apnea and diabetes
Medical EducationSpecialtiesWellness

Can Obstructive Sleep Apnea Treatment Help Diabetics?

September 13, 2013
Dana Lewis marathon
eHealthMedical EducationSocial Media

#HCSM Tweet Chat Founder Dana Lewis [PODCAST]

December 8, 2014

NanoViricides Reports Positive Anti-viral Effect of HIV Drug

August 16, 2011
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?