D.C. Report: ONC’s E-Consent Pilot Moves Forward

April 10, 2013
The Office of the National Coordinator for Health IT has moved into the next stage of what it’s simply calling the E-Consent Trial. The purpose of the trial is largely focused on patient education about consent options and ways to electronically capture that consent choice.

ONC E-Consent Pilot Moves into Next Stage The Office of the National Coordinator for Health IT has moved into the next stage of what it’s simply calling the E-Consent Trial, according to media reports. The purpose of the trial is largely focused on patient education about consent options and ways to electronically capture that consent choice.  According to the scope of work, the first goal is “Educate and inform individuals of their option to give individual choice (e.g. automate informed consent process, patient-centered decision making process) in a clinical setting to share their health information electronically.”  Second, the trial hopes to find innovate ways to “Ensure that individuals are knowledgeable participants in decisions about the sharing their electronic health information in a clinical environment.”  An additional focus of the project hopes to “Explore and evaluate ways of electronically obtaining and recording meaningful and informed choice from individuals in a clinical setting, regarding sharing their electronic health information.”

In early October, ONC awarded a $1.2 million contract to APP Design, an Itasca, Ill.-based software developer.  Since that time, ONC has established a pilot between a Buffalo, N.Y. area HIE, HealtheLink, and four physician offices, where the group is using tablet technology to explain and obtain “meaningful consent.”  Ideally, the 18-month project will yield “an open source tool that we can publicly make available for anyone to download and use in their environment,” said Kathryn Marchesini, a senior analyst and advisor at ONC.  "We realize that each HIE is unique, and there are some special local and state laws that may vary, and some nuances of wording may have to be worked through. But we hope that the materials we piloted can be leveraged by HIEs across the country."

ONC Sends Clinical Labs Survey to Understand Electronic Transmission Readiness Earlier this month ONC published an information collection request (ICR) seeking to collect key data from a sample of clinical laboratories nationwide for the Evaluation of the State Health Information Exchange Cooperative Agreement Program. The National Survey on Health Information Exchange in Clinical Laboratories, as it’s referred to, will assess and evaluate the electronic transfer of health information from clinical laboratories to ordering physicians. Specifically, it will focus on two key measures:

(1)  Percentage of laboratory facilities that are able to send structured lab results electronically to ordering physicians and

(2)  Percentage of lab results that are currently being sent electronically in coded format to ordering physicians.

Responses are due by Nov. 19 and should be submitted via Regulations.gov.  For additional questions, please contact CHIME Advocacy.

FDA Sets Up Patient Advisory Pool In an effort to increase patient input during regulatory formation, the Food & Drug Administration (FDA) is creating a pool of patient representatives who can more quickly move through conflict-of-interest restrictions.  According to officials at the FDA, a pilot program has been established at some review divisions in FDA’s drug, device and biologic centers in order to get more patients involved with drug review and approval processes.  FDA officials have said they hope to expand the program to other divisions of FDA within the next six to twelve months – then roll out the advisory pools to all FDA centers.  The agency still needs to define what types of meetings patients will be involved in, and how they will contribute to the process.

WirelessTechnology Systems Offer Both Risks and Opportunities  Today’s dynamic hospital environment with its numerous medical devices connected through wireless networks, Smart phones and other  devices would not have been possible just a few short years ago.  Add to this is a profusion of professional staff, clinicians and visitors competing for wireless capacity.  This environment brings with it many challenges related to wireless technologies and support systems, a challenge that is certainly obvious to most CIOs.  But assessing those challenges and developing remediation requires a major commitment amidst other competing priorities.  Earlier this month, the Association for the Advancement in Medical Instrumentation (AAMI) convened a group of stakeholders – FDA, FCC, Wi-Fi developers and providers, device manufacturers, CHIME, Kaiser Permanente and others – to share insights, challenges, and lessons learned and agree on a shared list of priority challenges to be addressed and next steps.

Understanding the scope of issues involved with the wireless environment is necessary to assessing areas for attention.  For example, management of the spectrum; inventory of wireless devices within the hospital, managing and optimizing wireless infrastructure and leveraging existing standards and determining the need for new standards.  To this last point, what is the role of government vs. the private sector; i.e., FDA entering the EHR space.   What are the obstacles to developing a highly reliable infrastructure?  These include such items as organizational silos keeping information separate, resource constraints, lack of technical competencies, BYOD (bring your own device) and BYOI (bring your own infrastructure) and perception that hospitals are not as agile as other industries and players who don’t want to play.   To achieve a high reliability infrastructure and address some of these obstacles, organizations are advised to:

  • Have a plan
  • Create a design that incorporates the concept of a system approach
  • Educate professionals, who will be managing these wireless networks
  • Include risk management and a hazard analysis
  • Understand devices and applications and what their networking requirements are and how they’ll be used.

Here is a copy of the workshop agenda and slides: Risks, Challenges and Opportunities of Wireless Technology Systems in Healthcare. CHIME will provide updates on next steps, including a future publication outlining the workshop outcomes.

A new telehealth program is targeted at three states with the highest density of veterans – Virginia, Montana and Alaska – and will set aside $300,000 for each state to upgrade its telehealth network and develop electronic health records that are compatible with the VA's VistA EHR.

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