Archive for July, 2011

FDA Workshop on Unique Device Identification in Health-Related Electronic Data Systems

July 21, 2011 Leave a comment

On July 21, the Food and Drug Administration (FDA) announced a public workshop titled, “Unique Device Identification (UDI) for Postmarket Surveillance and Enforcement.”  The event will take place in Bethesda, Maryland on September 12-13.   FDA will also provide a webcast option for participation.

The general focus of the workshop will be the use of UDI in health-related electronic data systems, including EHRs, PHRs, device registries, etc.  The draft agenda, which does not yet include a speaker list, is currently available here.

The Federal Register notice indicates a September 5 registration deadline; however, the website for the event mentions that registrants should sign up by August 29.  I suspect an event like this will fill up rather quickly.

My expectation is that the workshop will focus mostly on personal health devices such as monitors and implants, and not so much on medical imaging related devices.  This was also the focus of an Office of the National Coordinator for HIT (ONC) HIT Standards Committee-Clinical Operations Workgroup discussion back in March 2011.

Categories: EHR, FDA, meaningful use, research

HHS OIG Report: Early Review of States’ Planned Medicaid EHR Incentive Program Oversight

July 21, 2011 Leave a comment

The Office of the Inspector General of the U.S. Department of Health and Human Services (HHS) recently issued a report to the Centers for Medicare and Medicaid Services (CMS) titled, “Early Review of States’ Planned Medicaid Electronic Health Record Incentive Program Oversight.”

The report explores 13 states’ intentions and plans for ensuring the integrity of the Medicaid version of the EHR Incentive Program.  Specifically, the document outlines the eligibility requirements of the Medicaid version of the EHR Incentive Program, and explores which states are verifying that participants meet the eligibility requirements prior to issuing “meaningful use” incentive payments.

As a reminder, to be eligible for the Medicaid version of the EHR Incentive Program, a physician would need to have 30 percent or more of his/her patient volume supported by Medicaid (20 percent for pediatricians).  Unlike the Medicare version of the program, the Medicaid version also allows participation by certain types of allied health professionals in very specific practice settings.

Categories: EHR, meaningful use, Medicare

ACR Advocacy Update: July 2011

July 20, 2011 Leave a comment

The American College of Radiology’s (ACR) Government Relations and Economics Departments published the July 2011 issue of the ACR Advocacy Update. The ACR Advocacy Update is a monthly e-newsletter featuring contributions from ACR staff who work on federal and state legislative, regulatory, and coding/reimbursement policy issues.

To view previous issues of the ACR Advocacy Update, please visit the ACR Government Relations website.

FDA Releases Draft Guidance on Mobile Medical Applications

July 19, 2011 2 comments

Earlier today, the U.S. Food and Drug Administration’s (FDA) released draft guidance regarding the agency’s potential thinking on mobile medical applications. The draft discusses the circumstances under which a mobile app would be a regulated “device,” and how the agency intends to view and regulate various types of mobile applications.

FDA staff will hold a stakeholder teleconference and Twitter chat to discuss this topic later this afternoon. A replay of the teleconference will be available until July 26 by dialing 888-568-0616 or 1-402-998-1519.

The public comment period will be open for 90 days following the future publication of the draft guidance in the Federal Register. If you would like to comment and/or provide input to the ACR IT and Informatics Committee, please contact Michael Peters, ACR Director of Legislative and Regulatory Affairs, at 202-223-1670.

Categories: FDA, research

VA Awards Contract to Develop Open Source EHR Custodial Agent

On June 30, the Department of Veterans Affairs (VA) announced that it awarded the contract to develop the VA’s open source EHR Custodial Agent (OSEHRCA) to The Informatics Applications Group (TIAG).  The OSEHRCA will provide central governance for the community and should be completed later this summer.  The VA’s open source EHR will initially be based on the VA’s existing VistA software.

TIAG is currently soliciting feedback from interested parties regarding the development of the OEHRCA on its placeholder website.

Categories: EHR
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