2010-31159. Office of the National Coordinator for Health Information Technology; Health Information Technology; Request for Information Regarding the President's Council of Advisors on Science and Technology (PCAST) Report Entitled “Realizing the ...

AGENCY:

Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services (HHS).

ACTION:

Request for information.

SUMMARY:

This document is a request for comments regarding the recently released PCAST report and its implications for the nation's health information technology (HIT) agenda and ONC's implementation of the Health Information Technology for Economic and Clinical Health Act (HITECH Act).

DATES:

Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 17, 2011.

ADDRESSES:

Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments by any of the following methods (please do not submit duplicate comments).

• Electronically: You may submit electronic comments on this request for information at http://www.regulations.gov. Follow the “Submit a comment” instructions. Attachments should be in Microsoft Word or Excel, WordPerfect, or Adobe PDF.
• Regular, Express, or Overnight Mail: Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Attention: Steven Posnack, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave., SW., Washington, DC 20201. Please submit one original and two copies. Please also allow sufficient time for mailed comments to be received before the close of the comment period.
• Hand Delivery or Courier: Office of the National Coordinator for Health Information Technology, Attention: Steven Posnack, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave., SW., Washington, DC 20201. Please submit one original and two copies. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the mail drop slots located in the main lobby of the building.)

FOR FURTHER INFORMATION CONTACT:

Steven Posnack, Director, Federal Policy Division, Office of Policy and Planning, Office of the National Coordinator for Health Information Technology, 202-690-7151.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All comments received before the close of the comment period will be available for public inspection, including any personally identifiable or confidential business information that is included in a comment. Please do not include anything in your comment submission that you do not wish to share with the general public. Such information includes, but is not limited to: A person's Social Security number; date of birth; driver's license number; State identification number or foreign country equivalent; passport number; financial account number; credit or debit card number; any personal health information; or any business information that could be considered to be proprietary. We will post all comments received before the close of the comment period at http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

I. Background

On December 8, 2010, the President's Council of Advisors on Science and Technology (PCAST) released an important new report entitled “Realizing the Full Potential of Health Information Technology To Improve Healthcare for Americans: The Path Forward” (the PCAST Report). (The full report is available at http://www.whitehouse.gov/​administration/​eop/​ostp/​pcast and also available on ONC's Web site http://healthit.hhs.gov). PCAST is an advisory group of the nation's leading scientists and engineers who directly advise the President and the Executive Office of the President. PCAST makes policy recommendations in the many areas where understanding of science, technology, and innovation is key to strengthening our economy and forming policy that works for the American people. PCAST is administered by the Office of Science and Technology Policy (OSTP). PCAST's report and its recommendations have significant implications for the nation's HIT agenda and the implementation of the HITECH Act, passed as part of the American Recovery and Reinvestment Act of 2009 (Recovery Act) (Pub. L. 111-5). ONC seeks public comment on the PCAST report's vision and recommendations and how they may be best addressed.

II. Solicitation of Comments

ONC seeks comment on the questions below. Comments on other aspects of the PCAST report are also welcome.

1. What standards, implementation specifications, certification criteria, and certification processes for electronic health record (EHR) technology and other HIT would be required to implement the following specific recommendations from the PCAST report:

a. That ONC establish minimal standards for the metadata associated with tagged data elements;

b. That ONC facilitate the rapid mapping of existing semantic taxonomies into tagged data elements;

c. That certification of EHR technology and other HIT should focus on interoperability with reference implementations developed by ONC.

2. What processes and approaches would facilitate the rapid development and use of these standards, implementation specifications, certification criteria and certification processes?

3. Given currently implemented information technology (IT) architectures and enterprises, what challenges will the industry face with respect to transitioning to the approach discussed in the PCAST report?

a. Given currently implemented provider workflows, what are some challenges to populating the metadata that may be necessary to implement the approach discussed in the PCAST report?

b. Alternatively, what are proposed solutions, or best practices from other industries, that could be leveraged to expedite these transitions?

4. What technological developments and policy actions would be required to assure the privacy and security of health data in a national infrastructure for HIT that embodies the PCAST vision and recommendations?

5. How might a system of Data Element Access Services (DEAS), as described in the report, be established, and what role should the Federal government assume in the oversight and/or governance of such a system?

6. How might ONC best integrate the changes envisioned by the PCAST report into its work in preparation for Stage 2 of Meaningful Use?

7. What are the implications of the PCAST report on HIT programs and activities, specifically, health information exchange and Federal agency activities, and how could ONC address those implications?

8. Are there lessons learned regarding metadata tagging in other industries that ONC should be aware of?

9. Are there lessons learned from initiatives to establish information-sharing languages (“universal languages”) in other sectors?

Dated: December 7, 2010.

David Blumenthal,

National Coordinator, Office of the National Coordinator for HIT.