HIMSS Offers Guidance on Health IT Framework | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

HIMSS Offers Guidance on Health IT Framework

November 8, 2013
by Gabriel Perna
| Reprints


The Healthcare Information and Management Systems Society (HIMSS) has written a letter to Health and Human Services Secretary Kathleen Sebelius offering feedback on health IT regulation, pertaining to the Food and Drug Administration Safety and Innovation Act (FDASIA) 2012. 
The letter starts off with a clarification that health IT products used primarily for the subsequent transmission, storage or management of data, including electronic health records (EHRs) and Clinical Decision Support (CDS) systems, do not fit the "definition of, nor would be appropriately regulated as, medical devices." 
As such, HIMSS writes, these (health IT) products should "be subject to a new risk-based oversight framework that takes into account factors such as risk relative to intended use and cost/benefit of any proposed oversight and the construct of shared responsibilities, with the intent of ensuring patient safety and appropriate improvements in quality, effectiveness, and efficiency of care delivery."
HIMSS says this oversight framework should act in concert with medical device regulation framework from the standpoint of the end-user or manufacturer. 
"We recognize that health IT and medical devices are interwoven into a single, broad patient care ecosystem, and believe that the new health IT framework can complement the existing medical device regulatory process. Our comments offer proposed elements and rationales of such an oversight framework," HIMSS writes. 
In the letter, signed by Chair of the HIMSS Board of Directors Scott MacLean and President & CEO Steve Lieber, the advocacy group mentions four areas this framework should address. This includes: 
  1. Balancing the costs and benefits of any program proposal;
  2. Ensuring clear, consistent and non-duplicative language and enforcement;
  3. Being affordable to those expected to bear direct and indirect compliance costs; and
  4. Avoiding adding burdens that inhibit or delay improvements to systems that improve care delivery and safety.


Get the latest information on Health IT and attend other valuable sessions at this two-day Summit providing healthcare leaders with educational content, insightful debate and dialogue on the future of healthcare and technology.

Learn More



MGMA: Physician Compensation Data Illustrates Nationwide PCP Shortage

Primary care physicians’ compensation rose by more than 10 percent over the past five years, representing an increase which is nearly double that of specialty physicians’ compensation over the same period, according to the Medical Group Management Association (MGMA).

Circulation, Buoy Health Collaborate on Integrated Platform for Patient Transportation

Boston-based startup Circulation Health, a ride-ordering exchange that coordinates medical transportation logistics using Lyft and other transportation partners, is partnering with Buoy Health, also based in Boston, to integrate their platforms to provide patients with an end-to-end healthcare experience.

HITRUST Provides NIST Cybersecurity Framework Certification

The Health Information Trust Alliance (HITRUST), security and privacy standards development and accreditation organization, announced this week a certification program for the National Institute of Standards and Technology's (NIST) Cybersecurity Framework (Framework).

Report: Interoperability in NHS England Faces Similar Barriers as U.S. Healthcare

Electronic patient record interoperability in NHS England is benefiting patient care, but interoperability efforts are facing barriers, including limited data sharing and cumbersome processes falling outside of the clinician workflow, according to a KLAS Research report.

Geisinger National Precision Health Hires Illumina Exec to Lead Business Development

Integrated health system Geisinger has hired a high-profile genetic counselor to head up business development for Geisinger National Precision Health, which was created to extend the Geisinger model on the national scene.

$30M VC Fund Launched to Spur Innovation in Cardiovascular Care

The American Heart Association, together with Philips and UPMC, has announced the launch of Cardeation Capital, a $30 million collaborative venture capital fund designed to spur healthcare innovation in heart disease and stroke care.