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
    Medicare Helps Seniors, and People with Disabilities & ESRD
    November 27, 2023
    The Link Between Allergies and Sinusitis & Strategies for Relief
    November 27, 2023
    What Health Complications Can a Sunburn Cause?
    November 22, 2023
    From Mountains to Metropolis: A Guide to First Aid Approaches
    November 20, 2023
  • 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
    accident injuries healthworkscollective
    Beyond the Fender Bender: Accident Injuries, Actions, and Recovery
    February 5, 2021
    5 Common Misconceptions About Naturopathic Medicine
    October 24, 2019
    Nixed NHS Procedures Spark Concern for Varicose Vein Patients
    July 18, 2018
    Latest News
    Automation in Pharmacovigilance: A Double-Edged Sword
    November 15, 2023
    What Does Science Say About Modern Health Practices?
    November 12, 2023
    Harnessing the Power of Email Marketing in Healthcare
    October 26, 2023
    10 Proven Strategies to Level Up Your Health Business
    October 25, 2023
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: FDASIA Health IT Report Issued
Share
Sign In
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Have an existing account? Sign In
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > eHealth > FDASIA Health IT Report Issued
eHealthPolicy & LawTechnology

FDASIA Health IT Report Issued

David Harlow
Last updated: 2014/04/14 at 8:00 AM
David Harlow
Share
0 Min Read
SHARE

Pages from HealthITreport_FINALThe FDA, the FCC and ONC issued a long-awaited joint report with a proposed strategy and recommendations for a Pages from HealthITreport_FINALThe FDA, the FCC and ONC issued a long-awaited joint report with a proposed strategy and recommendations for a risk-based framework for regulation of Health IT.

The report identifies four key priority areas and outlines next steps to take in each area:  

I. Promote the Use of Quality Management
Principles;
II. Identify, Develop, and Adopt Standards and
Best Practices;
III. Leverage Conformity Assessment Tools; and
IV. Create an Environment of Learning and
Continual Improvement

This report should be read together with the FDA framework for regulation of mobile medical applications which was supposedly up in the air pending release of this report. It now seems that they are directed at related, but different, parts of the ecosystem. Both are part of a bigger story, including pending legislaton.

The nub of the report: the workgroup recommendation that the agencies leave regulation of much of health IT to the regulated community, in part through the creation of a public-private partnership under the umbrella of a newly proposed organization, the Health IT Safety Center. “The Health IT Safety Center would convene stakeholders in order to focus on activities that promote health IT as an integral part of patient safety with the ultimate goal of assisting in the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts.Things that create real risk of harm should be more closely regulated.”

Health IT is divided up into categories (much like FDA medical device categories 1, 2 and 3). The first two categories (administrative health IT functions and health management health IT functions) include functionality that comes with relatively low safety risks, and therefore should not be the focus of regulatory scrutiny. (“We believe the potential safety risks posed by health management health IT functionality are generally low compared to the potential benefits and that strategies to assure a favorable benefit-risk profile of these functionalities should adopt a holistic view of the health IT sociotechnical system. As such, if a product with health management health IT functionality meets the statutory definition of a medical device, FDA does not intend to focus its oversight on it. Rather, FDA would focus its attention and oversight on medical device health IT functionality, such as computer aided detection software, remote display or notification of real-time alarms from bedside monitors, and robotic surgical planning and control. Such products are already the focus of FDA’s oversight . . . . “)The report wraps up with the following:

Health IT presents many new opportunities to improve patient care and safety. To promote innovation, protect patient safety and avoid regulatory duplication, the Agencies propose the creation of an agile, narrowly-tailored, risk-based health IT regulatory framework that primarily relies on ONC-coordinated activities and private sector capabilities, and focuses on health IT functionality rather than on the platform(s) on which it resides. We believe that active and ongoing stakeholder engagement is critical to the successful development and implementation of such a framework. After receiving public input and finalizing the proposed framework, the Agencies intend to continue active engagement with stakeholders in an ongoing collaborative effort to implement a health IT framework that promotes the electronic use and exchange of health information and helps the American public realize the tremendous potential benefits of health IT.

My loyalties are divided on this issue. I was a dyed-in-the-wool central health planning sort of regulator when I worked in government, way back when. These days, I am more of a free-marketeer, though I really haven’t fully unshackled myself from the notion that some regulation is a good thing, particularly where we do not have a proven efficient market and where public health is at stake. I have been through enough cycles of regulation and de-regulation (and can deliver the rhetoric supporting each in my sleep) to know that neither theory has a monopoly on Truth. Thus, while I like the government’s espousal of an agile regulatory framework — as far as I’m concerned, the jury’s still out on the decidedly hands-off approach described in this draft.

Detailed feedback is sought on the report’s recommendations; comments may be filed through July 7, 2014.

TAGGED: FDA, Health IT

Sign Up For Daily Newsletter

Be keep up! Get the latest breaking news delivered straight to your inbox.
By signing up, you agree to our Terms of Use and acknowledge the data practices in our Privacy Policy. You may unsubscribe at any time.
David Harlow April 14, 2014 April 14, 2014
Share This Article
Facebook Twitter Copy Link Print
Share
Previous Article icd 10 delay ICD-10 Delay: Does ICD-10 Lack Clinical Value?
Next Article Medical Device Marketing, Product Marketing, Online Marketing What the Leader of the World’s Largest Medical Device Community Says About Marketing

Stay Connected

1.5k Followers Like
4.5k Followers Follow
2.8k Followers Pin
136k Subscribers Subscribe

Latest News

Unlocking a Healthier You: Shedding Unwanted Pounds
Weight Loss November 29, 2023
hearing aids
Navigating the World of Hearing Aids with Confidence
Wellness November 29, 2023
find affordable hearing aids
Finding Quality Affordable Hearing Aids That Fit Your Lifestyle
Wellness November 29, 2023
Rhinoplasty
Rhinoplasty 101: 6 Factors To Consider Before Going Under The Knife
Surgery November 29, 2023

You Might also Like

healthcare business website
Technology

Choosing the Right Domain Name for Your Healthcare Business

November 27, 2023
healthcare software development
Technology

Shaping the Future of Healthcare Software Development

November 23, 2023
AI in pharmaceutical industry
Pharmaceuticals

Automation in Pharmacovigilance: A Double-Edged Sword

November 15, 2023
Modern Health Practices
Medical Innovations

What Does Science Say About Modern Health Practices?

November 12, 2023
Subscribe

Subscribe to our newsletter to get our newest articles instantly!

Follow US
© 2008-2023 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Lost your password?