Washington Debrief: Direct Guidance Released for Stage 2 Assistance

June 4, 2013 by Jeff Smith, Director of Public Policy at CHIME
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Washington Debrief: Direct Guidance Released for Stage 2 Assistance
Jeff Smith, Director of Public Policy at CHIME
  1. What types of health IT should be addressed by the report developed by FDA, ONC, and FCC?
  2. What are the risks to patient safety posed by health IT and what is the likelihood of these risks?  What factors or approaches could be included in a risk-based regulatory approach for health IT to promote innovation and protect patient safety?
  3. Are there current areas of regulatory overlap among FDA, ONC, and/or FCC and if so, what are they? Please be specific if possible.  If there are areas of regulatory overlap, what, if any, actions should the agencies take to minimize this overlap? How can further duplication be avoided?

These wide-reaching questions mirror those that a 30-member FDASIA Workgroup was asked to answer over the summer.  While the official deadline is August 31, the RFC reads, “For commenters that wish to have their comments considered by the FDASIA Workgroup, we encourage you to submit your comments as early as possible and preferably before June 30, 2013.”  Several groups in Washington have convened in an effort to inform FDASIA Workgroup deliberations.

CHIME StateNet to Tackle Patient Matching, Consent Policy through New Workgroups

CHIME Members and CHIME Foundation Firm members:  We would like to invite you to join our StateNet workgroups!  We are looking for health IT stakeholders with experience working on patient matching and consent policy.  The workgroups will have a teleconference/phone call component and an online component through CIO StateNet.  After joining StateNet, we invite you to join the Patient Matching Group and/or the Consent Policy Group.  To begin, each workgroup will perform an environmental scan to better understand where gaps in policy and technology exist.  Then, each group will evaluate existing or possible solutions for recommendation to the StateNet Board.

In the coming weeks, we will be inviting vendors, HIEs, RECs, and other stakeholders to join these groups.  Please invite any colleagues you have that have experience with these issues.  To come up with viable solutions, we need insight from all stakeholders.

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