Archive for September, 2011

IOM Releases Letter Report on Occuptional Information and EHRs

September 30, 2011 Leave a comment

On September 29, the Institute of Medicine (IOM), with the sponsorship of the National Institute for Occupational Safety and Health (NIOSH), released a letter report regarding “Incorporating Occupational Information in Electronic Health Records.”

The report describes radiation exposure to be among the most useful, but also the most difficult, occupational data to obtain.  It indicates that for information related to occupational exposures (chemical, physical, or radiation), clinicians can be linked to general resources; however, the value of resources that are not seamlessly incorporated into the clinician’s workflow is questioned.  The report mentions that HL7 standards exist for context-aware information retrieval that would allow technology to associate an exposure with an item in the work history, which can then be pulled into clinical decision support.

To access the report, please visit the IOM’s website.


NRC Exploring E-Signatures in Written Directives

September 27, 2011 Leave a comment

During its September 22-23 business meeting, the U.S. Nuclear Regulatory Commission’s (NRC) Advisory Committee on the Medical Uses of Isotopes (ACMUI) discussed the issue of identifying electronic signature standards for written directives.  The discussion, a continuation of the dialog started by NRC back in October 2010, was intended to inform NRC staff as they write guidance for regional investigators on the requisite characteristics of acceptable e-signatures.

NRC staff presented their preliminary thoughts on potential characteristics of acceptable e-signatures, particularly the need for:

  • Unique identification
  • Authentication
  • Non-repudiation
  • Data integrity assurance

Members of the ACMUI mentioned that other federal agencies and programs deal with electronic standards and NRC should be careful not to conflict with things such as standards, implementation specifications, and certification criteria for EHR technology.  The guidance must also be flexible enough to be suitable for licensees with low or no levels of HIT adoption; for example, any licensees that store written directives electronically but do not use EHR technology to do so.

Ultimately, ACMUI members decided to form a subcommittee to report back with a recommended approach for how NRC might be able to gather the information they need to develop good guidance.

Categories: radiation safety

Recap of Recent Federal HIT Policy Developments: Part 6

September 16, 2011 1 comment

On September 12-13, the U.S. Food and Drug Administration held its public workshop to discuss the draft guidance on mobile medical applications.  Dr. David Hirschorn participated on behalf of the American College of Radiology’s IT and Informatics Committee.  The event was summarized in a series of articles by Cynthia E. Keen for AuntMinnie.

On September 14, the HIT Policy Committee held its regular monthly meeting.  Of particular interest was the announcement of the imminent retirement of Judy Sparrow who was going to use the services, the ONC staff person who administers the HIT Policy Committee and Standards Committees and assorted workgroups. Additionally, CMS staff provided an update regarding participation statistics for the Medicare and Medicaid EHR Incentive Programs.  Specialist participation remains very low across the board, despite specialists outnumbering primary care physicians in terms of the denominator.

On September 12, the NIH National Institute of Biomedical Imaging and Bioengineering (NIBIB) discussed the elements of its new strategic plan which will focus, in part, on informatics and mobile health innovations.  The discussion occurred during the regular business meeting of the National Advisory Council for Biomedical Imaging and Bioengineering.

All week, the Office of the National Coordinator for HIT (ONC) has been involved with several efforts and announcements, including its final strategic plan, a new website for communicating EHR promotional  information to patients and providers, and other initiatives largely unrelated to radiology.  One of the more interesting announcements was a challenge (prize competition) for software developers to create applications to facilitate the reporting of adverse events related to medical devices.  The deadline for submitting applications is December 2.

ACR to Participate in FDA Workshop on Mobile Medical Applications Draft Guidance

September 8, 2011 3 comments

On September 12-13, the American College of Radiology (ACR) will participate in a Food and Drug Administration (FDA) workshop regarding its recently published mobile medical applications draft guidance.

Dr. David Hirschorn (Staten Island University Hospital) of the ACR IT and Informatics Committee-FDA workgroup will be a panelist on the topic of “level of oversight and proposed approach; following current classifications and oversight controls.”  His panel will discuss the following questions about the draft guidance, as well as any additional questions brought up by attendees in the audience:

  • Is the level of oversight appropriate for mobile apps?
  • What part of current requirements needs clarity for mobile medical apps?
  • Is there a different general approach to effectively oversee mobile medical apps?
  • Are there other factors to be considered in effectively assuring safety of mobile medical apps?
  • How best can the guidance provide more clarity to mobile medical app manufacturers?

The workshop will take place at the FDA’s White Oak Campus in Silver Spring, Maryland and will be available to public stakeholders via webcast.

Categories: FDA, research
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