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
    improving patient experience
    6 Ways to Improve Patient Satisfaction Within Hospitals
    December 1, 2021
    degree for healthcare job
    What Are The Health Benefits Of Having A Degree?
    March 9, 2022
    custom software development is changing healthcare
    Digital Customer Journey Mapping and its Importance for Healthcare
    July 21, 2022
    Latest News
    6 Easy Healthcare Ways to Sit Less and Move More Every Day
    September 10, 2025
    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
  • 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
    Feinberg’s Simulation-Based Training Program Wins Innovations Challenge
    November 16, 2012
    ACA Delays
    Top 8 ACA Delays: Blatantly Illegal or Temporary Courses of Action?
    July 7, 2014
    Vegetarina Dental Concerns Marielaina Perrone DDS
    Oral Health Concerns For Vegetarians
    February 14, 2013
    Latest News
    Healthcare at a Crossroads: Why Leadership Matters More Than Ever
    September 9, 2025
    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
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: FDASIA Health IT Report Issued
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 > FDASIA Health IT Report Issued
eHealthPolicy & LawTechnology

FDASIA Health IT Report Issued

David Harlow
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.

More Read

How To Get Rid Of Belly Fat: The Roles Diet, Stress, And Exercise Play In Belly Fat Reduction (Part 4)
InSite Vision Is Developing Treatment For Common Eye Disease Blepharitis, For Which There Is Currently No Approved Treatment
Calling for Responsible Healthcare Journalism
Internet of Things (IoT) + healthcare = what, exactly?
Vaccines in the Pipeline and Vaccine Economics

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:FDAHealth IT
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

a woman walking on the hallway
6 Easy Healthcare Ways to Sit Less and Move More Every Day
Health
September 9, 2025
Clinical Expertise
Healthcare at a Crossroads: Why Leadership Matters More Than Ever
Global Healthcare
September 9, 2025
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

You Might also Like

Asset Management the Siemens Way

November 28, 2012

Mass. Proposes Plan to Cut Acute Healthcare Costs

May 8, 2012
BusinesseHealthPolicy & Law

7 Healthcare Cybersecurity Tips To Protect Your Data

November 9, 2018
Health care

What is a Pharmacy Technician and What is Their Role in the Healthcare Industry?

December 8, 2021
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?