The Committees have been extraordinarily productive—in fact, they’ve been called the hardest working FACAs in the government. They and their dozen or so workgroups have conducted more than 150 meetings in 2011. Their recommendations have shaped key policies, programs, and technical activities to achieve HITECH goals since their inception in May 2009.

In 2011 alone, their recommendations included:

• Meaningful Use Stage 2 policies and standards
• Quality measures for Meaningful Use
• Security policy framework for electronic health records (EHRs)
• Policies for the Query Health project
• Patient view and download of their information
• EHR usability
• Provider directories
• Metadata standards for patient identification, provenance, and privacy, following the Report of the President’s Council of Advisors on Science and Technology (PCAST)
• Patient matching
• Standards and specifications for the nationwide health information exchange

The members of these committees and workgroups have generously volunteered their time, knowledge, professional contacts, patience, and collegiality. Their work is helping America modernize its health care system through health IT. And, as we know, health IT is foundational to building the health system of the 21^st Century where care is better coordinated, patient centered, and safer; and where we pay for the right care, not just more care. ONC, and the nation as a whole, are immensely indebted to them. Kudos and thank you to each and every member for the Committees and their workgroups—your work is truly appreciated.

To this end, ONC convened a Nationwide Health Information Network (NwHIN) Power Team (NwHIN Team) tasked to assist the ONC in defining this set of standards, services, and policies by:

1. Evaluating the specifications developed for the Exchange and Direct pilots with respect to their usability and scalability to support nationwide health information exchange

2. Recommending those specifications that could be integrated and deployed to support the secure transport and exchange of electronic health information at a national scale, and identifying where further work may be needed

Over the past few months, the NwHIN Team held a series of public meetings to first develop an assessment methodology, and then to assess the Exchange and Direct specifications as potential NwHIN standards, services, and policies.

On September 28, 2011, the HITSC provided recommendations regarding standards and specifications for the nationwide health information network, via this transmittal letter [PDF – 805 KB].

As noted in the transmittal letter, the committee has recognized need for further investigation of the Exchange specifications and has recommended that ONC perform further assessment of industry adoption, and deployment, operational, and administrative complexity of the Exchange specifications – specifically to include inputs from people who have implemented these specifications in organizations other than Federal agencies, and from organizations that have implemented a technology stack different from that represented in the Exchange specifications.

II. Request for Comments Purpose

The NwHIN Power team is seeking input from Exchange implementers regarding their experiences in implementing the Exchange specifications; setting up the required operational and administrative infrastructure; and using Exchange to meet their operational needs.  We are specifically interested in hearing the first-hand experiences and observations of individuals involved in the implementation of the Exchange specifications, and in the maintenance and use of Exchange in an operational environment.

Following analysis of the comments received through December 15, 2011, the HITSC intends to present its recommendations to the ONC to help inform decisions regarding future investments in additional NwHIN pilots and specification development.

III. Solicitation of Comments

Introduction

The NwHIN Power team is seeking comments from Exchange implementers regarding their experiences in implementing the Exchange specifications; setting up the required operational and administrative infrastructure; and using Exchange to meet their operational needs.  We are specifically interested in hearing the first-hand experiences and observations of individuals involved in the implementation of the Exchange specifications, and in the maintenance and use of Exchange in an operational environment.  We request that the implementer providing the comments address the following questions.

Instructions

You may submit your comments in the following way:

1. Email the completed survey to ONC.request@hhs.gov. Please be sure to include “NwHIN Power Team” in the subject line.

Please submit your comments by no later than 5 p.m./Eastern Time on Dec 15, 2011.

Questions:

1.      Please identify yourself, your organization, and your position within the organization.

2.      When did your organization implement the Exchange specifications?

3.      Why did your organization implement the Exchange specifications?   Are the functional capabilities that Exchange provides adequate for your current and expected information-exchange purposes?

4.      What business functions does Exchange currently support in your organization?

5.      What is the current monthly volume of documents that are transferred among different organizational entities as part of your implementation?

6.      What methods and protocols do you use today for clinical exchange?  When considering the exchange activities anticipated for the next few years, what proportion do you expect will use Exchange?  What other methods and protocols do you plan to use over the next few years?

7.      Have the organizations with whom you want to exchange data implemented Exchange?  If not, do they plan to do so?  If they are not implementing Exchange, what alternatives are you considering using for these exchanges?

8.      What was your personal role in the implementation of the Exchange specifications?

9.      Which of the following Exchange specifications did you implement?

–        NHIN Messaging Platform Specification

–        NHIN Web Services Registry Specification

–        NHIN Authorization Framework Specification

–        NHIN Patient Discovery Specification

–        NHIN Query for Documents Specification

–        NHIN Retrieve Documents Specification

–        NHIN Access Consent Policies Specification

–        NHIN Health Information Event Messaging (HIEM) Specification

–        NHIN Document Submission Specification

–        NHIN Administrative Distribution Specification

10.  Did you implement these specifications as prescribed, or did you make some adjustments for your environment?  If the latter, what adjustments did you make at the time of initial implementation or have you made since?  Were these adjustments made through bilateral agreements or did they apply to all participants in your exchange?

11.  How easy or difficult were the Exchange specifications to understand, interpret, and implement?   Compared to other service-oriented implementations you’ve been involved with, was Exchange easier, harder, or about the same level of complexity?

12.  What operational and administrative coordination and technical infrastructure have you needed to put in place in order to deploy and operate Exchange?

13.  How many hours of technical time did the project entail before reaching full interoperability?

14.  What other questions do you wish we had asked about your experience deploying, operating, and maintaining your Exchange implementation?

The Health Information Technology Standards Committee (HITSC) is a federal advisory committee that advises the U.S. Department of Health and Human Services (HHS) and the Office of the National Coordinator (ONC) on federal HIT standards issues, including electronic health record (EHR) certification criteria and implementation specifications for the meaningful use of EHRs for the Medicare and Medicaid EHR Incentive Programs. Eligible professionals (EP) and eligible hospitals (EH) who seek to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required by statute to use Certified EHR Technology.  Once certified, Complete EHRs and EHR Modules can be used by EPs and EHs, or be combined, to meet the statutory requirement for Certified EHR Technology.

To this end, in June 2010, HHS released the Temporary Certification Program Final Rule, which established certification programs for purposes of testing and certifying health information technology. This final rule established a process through which organizations can become an ONC-Authorized Testing and Certification Body (ATCB) to test and certify EHR technology. The temporary certification program was established to ensure that Certified EHR Technology is available for adoption by health care providers who seek to qualify for the Medicare and Medicaid EHR incentive payments beginning in 2011. ONC-ATCBs will be required to test and certify EHR technology (Complete EHRs and/or EHR Modules) for compliance with the standards, implementation specifications, and certification criteria adopted by the Secretary of HHS on July 13, 2010.

In collaboration with ONC, the National Institute of Standards and Technology (NIST) developed the functional and conformance testing requirements, test cases, and test tools to support the proposed Health IT Certification Programs.  These conformance test methods (test procedures, test data, and test tools) help ensure compliance with the meaningful use technical requirements and standards.

II. Request for Comments Purpose

The HITSC Implementation Workgroup is collecting feedback on the progress of the EHR product certification program now that it has had certifying EHR technology on Stage 1 Meaningful Use criteria for almost a year.  The intent is to get feedback on the process for establishing the ONC-ATCBs, for communicating the testing and certification criteria, and for testing and certifying EHR technology.

Following analysis of the comments received through the approximately 30-day public comment period, the HITSC Implementation Workgroup intends to make recommendations to the HITSC regarding the EHR Certification Program for Stage 2 Meaningful Use.

III. Solicitation of Comments

A. Instructions

You may submit your comments in two ways:

1. Use the comment section below to provide your feedback via the Federal Advisory Committee (FACA) Blog. Comments will be accepted on a rolling basis.
2. Download a copy of the survey [DOCX – 18 KB]; fill it out and email the completed survey to ONC.request@hhs.gov. Please be sure to include “Implementation WG Comments” in the subject line.

Please submit your comments by no later than 5 p.m./Eastern Time on June 17, 2011.

Thank you! 

Judy Murphy and Liz Johnson, Co-Chairs, HITSC Implementation Workgroup

NOTE: 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.

If you have questions, please contact Judy Sparrow, Office of the National Coordinator, HHS, 330 C Street, SW., Washington, DC 20201, judy.sparrow@hhs.gov

1.  Please indicate what ONE group best describes you:

_____  Authorized Testing and Certification Body (ATCB)

_____  Complete EHR Product Supplier/Vendor/Developer

_____  Modular EHR Product Supplier/Vendor/Developer

_____  Eligible Hospital/Provider who has or will need to self-certify EHR technology

            in order to attest for Stage 1 Meaningful Use

_____  Eligible Hospital/Provider using certified EHR technology and planning to attest

            to meaningful use in 2011 or 2012

_____  Regional Extension Center

_____  Association representing healthcare or HIT

_____  Other (specify):  __________________________________________________  

2.  Please indicate the size of your group:

            ____ Small                    ____ Medium                    ____ Large  

3.  What did you gain from the Temporary Certification Program that you did not expect?  

4.  What part(s) of the Temporary Certification Program worked well and that you would not want to see changed?  

5.  What 3 Temporary Certification Program testing and certification process points were the confusing / most misunderstood?  For these points, what could be improved and how?

            (1)

            (2)

            (3)

 6.  What 3 meaningful use measures and their corresponding certification criteria and test procedures seemed not to be in alignment and caused confusion for you?

            (1)

            (2)

            (3)

 7.  Are the certification criteria clear?

            ____ Yes                    ____ No

            If no, which criteria and how it can be improved?  

8.  Was the level of specificity appropriate?

            ____ Yes                    ____ No

            If no, how it can be improved?  

9.  Should certain certification criteria be combined or decomposed differently?

            ____ Yes                    ____ No

            If yes, which criteria and why?  

10.  Should certain certification criteria be scoped differently?

            ____ Yes                    ____ No

            If yes, which criteria and why?  

11.  Please comment on the balance of process-oriented vs. outcome-oriented certification criteria.  

12.  Do you have any suggestions for improving the ONC-approved test procedures for EHR certification?  

13.  Would it be beneficial if more choreographed/combined test procedures were developed that permitted an EHR developer to satisfy multiple certification criteria at once?

            ____ Yes                    ____ No  

14.  In what ways can the test procedures be combined to facilitate the testing of certification criteria within the context of clinical workflow?  

15.  Please provide specific instances where the ONC-approved test method can be improved to reduce ambiguity, inconsistency with criteria, and addition of implicit requirements beyond the certification criteria.  

16.  How would you rate your certification experience on a scale from 1 to 6 (circle one)

       1            2            3            4            5            6

       Difficult                                                   Easy 

17.  Other Comments or Suggestions

The document linked here includes a brief summary of what HIPAA provides for each of the principles and the Tiger Team’s recommendations to date. The Tiger Team is eager to hear from the public about gaps in this framework that still need to be addressed.

Please use the comment section below to provide your feedback via the Federal Advisory Committee (FACA) Blog. Comments will be accepted on a rolling basis. However, the Tiger Team is in the process of setting their agenda for the summer, and comments submitted by May 11 will assist the Tiger Team in building the agenda.

Privacy & Security Tiger Team Chairs, Deven McGraw and Paul Egerman

Health IT is currently in a period of transition as the nation moves toward new expectations of functionality and performance under meaningful use. At the same time, expectations for IT, in general, are being raised to even higher levels – information must be interconnected, accessed via an understandable user interface, conveniently available, and ubiquitous. Certainly the level of user expectation for electronics and applications in the entertainment and social media world will push the development envelope in clinical and administrative settings. The way this world interacts and generates data and information is evolving – with inevitable implications for the workflow of health professionals who succeed and fail by the quality of available information.

We recently came across a news piece on bedside discussion, which illustrated how these implications are coalescing in a game-changing fashion. A physician and a person receiving care were using a tablet with access to the medical record and diagnostic images. The person said, “I finally understand my disease.” The physician said, “That is the most rewarding patient interaction I have had – it’s why I’m a doctor.”

This hearing will bring a wide range of individuals together to present many aspects of usability.  A usability discussion is a multi-stakeholder one that requires developers, users, policy-makers, and patients. It requires innovators who would bridge the gap between what is and what can be. It requires participation from the usability experts – academics and analysts who have studied the field in and outside of health care. It requires those that would provide insight on how this nation can build a market around what we value in our technology, beyond functional requirements. As health IT evolves, we need to understand the potential of new levels of usability and the challenges of realizing it.

The solutions to our usability challenges rest not with any one stakeholder group. We cannot expect the developers to bear sole responsibility for a solution any more than we can expect a comprehensive policy mandate on usability to be successful. Usability is in the details and in all levels of structure, process, and design. There is not one single thing that makes it right or wrong. The solution will come from experiments and feedback and on-going evolution. The solution will also come from honest communication from all stakeholder groups and earnest planning to address a challenge that can determine the pace of technical evolution.

Come and join us in this rich dialog. We look forward to your participation. You may attend the hearing in person or listen via phone or computer. In addition, we welcome your comments on the blog post and will keep it open for comments until April 29, following the hearing.

The HITPC has developed a preliminary set of recommendations [PDF - 187 KB] specifically designed to solicit additional public feedback. This request for comment [PDF - 13 KB] (RFC) solely represents the preliminary thinking of the HITPC. The goal of sending out this RFC early is threefold:

1. Provide some signal to the industry of potential new EHR functionalities that the HITPC may recommend to help the industry get a head start on developing new functionalities.
2. Extend the public discussion of future stage MU definitions through a more formal public comment process well in advance of its formal final stage 2 recommendations to be issued in the summer of 2011.
3. Request input on specific questions.

Following analysis of the comments received through the 45-day public comment period, the HITPC intends to revisit these recommendations in its public meetings in the Spring of 2011. At that time, the HITPC will be able to review public comments in the context of the early feedback from providers on experience with stage 1 MU. In addition, the HITPC will consider additional input from its other workgroups working on quality measures, information exchange, and privacy and security.

The HITPC approached its task of developing proposed stage 2 objectives by first developing a longer-term vision for MU and then determining what an appropriate stage 2 stepping stone would be to reach that vision. For this reason, the matrix also includes possible stage 3 objectives; however, they are only included to provide context for the Stage 2 recommendations. Therefore, for the purpose of this RFC, the HITPC is primarily interested in comments on the proposed Stage 2 objectives at this time.

The Health IT Standards Committee (HITSC) would like your thoughts and comments on new initiatives being considered by the Office of the National Coordinator for Health Information Technology (ONC) through the Standards and Interoperability (S&I) Framework.

The objective of the S&I Framework is to create a robust, repeatable process that will enable ONC to execute on initiatives that will help improve interoperability and adoption of standards and health information technology. The S&I Framework includes processes and tools that will streamline and coordinate the execution of the initiatives to support the goals of the ONC and the HITECH Act.

More specifically the S&I Framework will enable:

• Linkage of objectives, challenges, use cases, requirements, and standards across the solution development lifecycle; e.g., pre-discovery, discovery, implementation, pilot, and evaluation
• Repeatable mechanisms for harmonization and integration of existing standards  as well as identification of new standards
• Development of tools that enable consistent, robust, and testable solutions; e.g., test suite to validate an implementation against a specification
• Integration of multiple Standard Development Organizations (SDOs) with different expertise across the solution development lifecycle
• Leveraging of federal guidance and best practices

More detail on the S&I Framework is available here [PDF - 1.8 MB] (Refer to pages 9-18)

The S&I Framework will be utilized to execute on a number of initiatives – each of which will seek to address a challenge that exists today. Initial efforts have resulted in the development of a set of materials and tools, including the Prioritization Framework [XLS - 78KB], and Proposed Initiative Summaries [PPT - 1.2MB].

The Health IT Standards Committee would like your comments by December 23 on these materials, which will inform the set of Initiatives that will be executed through the S&I Framework.

Prioritization Framework: The Prioritization Framework provides a set of criteria that can be applied to guide the prioritization of initiatives and their development through the S&I Framework. The criteria are grouped into four broad categories: Importance/Relevance, Feasibility, Usability, and Evidence-Based Medicine & Research Support. These four categories are aligned to the four-domain scheme proposed by the National Quality Forum (NQF) and based on previous work done by the National Committee for Quality Assurance (NCQA), Institute of Medicine (IOM), The Joint Commission, and the Centers for Medicare & Medicaid Services (CMS) to capture criteria that evaluate quality measures. These categories are further described within the document.

The Prioritization Framework is the proposed approach moving forward to analyze future initiatives and priorities raised across the health care community. It will apply to both short- and long-term priorities. Short-term priorities are driven by support for Meaningful Use requirements and the Nationwide Health Information Network, including the Virtual Lifetime Electronic Record (VLER). Long-term prioritization focuses on broader requirements, challenges, and goals of the U.S. health care system and its communities.

The Prioritization Framework is currently a template and in spreadsheet format with different tabs covering instructions, a glossary, and the criteria descriptions. The Prioritization Framework can be found here [XLS - 78KB].

As you review the Prioritization Framework, your responses to the questions below and additional comments would be appreciated.

• Are the current criteria appropriate and sufficient to evaluate Initiatives?
• Are there additional criteria within the four categories that should be included?
• ONC will be using the Prioritization Framework to evaluate future initiatives that may pass through the S&I Framework. We would ask you to review the proposed initiatives executive summaries using the Prioritization Framework. We would also ask you to apply weightings on these criteria as your review the initiatives, based on the level of importance you attach to each criteria, and also to use the Prioritization Framework to score new initiatives you may propose as part of your comments. We will use this feedback to evaluate the criteria in the Prioritization Framework and the various weightings that could be used to score initiatives.

Proposed Initiative Executive Summaries: This document includes a portfolio of several initiatives under consideration, for review and selection by ONC leadership, in consultation with appropriate steering bodies and advisory groups. These summaries include results of the initial analysis conducted by internal ONC staff and contractors to determine specific short-term priority investment to be undertaken by the S&I Framework project. Each initiative would represent important steps for ONC and the national health care community necessary to improve outcomes through the use of health information technology. These summaries can be found here [PPT - 1.2MB].

As you review the Initiative Executive Summaries, your responses to the questions below and additional comments are appreciated.

• Is the challenge statement listed for each initiative accurate? What are your general thoughts about this challenge statement? Is it an important initiative to you and the stakeholder community you work in or represent?
• Is the scope of the initiative acceptable, and if not, what changes would you suggest?
• Are the outcomes specified for each initiative reasonable and achievable, and if not, how would you refine them?
• What additional initiatives are not included that should be considered by ONC and the HITSC? Please provide specific details on the challenge statement of the initiative, and the scope of the initiative you are proposing.

Your thoughts and comments in this process would be helpful as ONC develops the Standards & Interoperability Framework and launches future initiatives.

• Jonathan Perlin, MD, Chair, Health IT Standards Committee
• John Halamka, MD, Co-Chair, Health IT Standards Committee

The tiger teams proposed important measure concepts for each of their domain areas. The teams then presented these recommendations in a report, “Tiger Team’s Summary Report,” which was submitted to the Quality Measures Workgroup on October 28, 2010.

After reviewing the tiger teams’ recommendations, the Workgroup revised and consolidated the measure concepts and now requests public comment on the measure concepts proposed within this document: Measure Concept List [XLS - 28KB]. The Workgroup requests general comments and specific examples of measures for each measure concept that fit the following criteria:

• HIT-sensitive—Capable of being built into electronic health record (EHR) systems with implementation of relevant health IT functions (e.g., clinical decision support) that result in improved outcomes and/or clinical performance.
• Parsimonious—Applies across multiple types of providers, care settings and conditions.
• Demonstrates preventable burden—Supports potential improvements in population health and reduces burden of illness.
• Assesses health risk status and outcomes—Supports assessment of patient health risks that can be used for risk adjusting other measures, and assessing changes in outcomes, including general cross-cutting measures of risk status and functional status and condition-specific measures.
• Longitudinal—Enables assessment of longitudinal, condition-specific, patient-focused episodes of care.

Comments to the workgroup can be submitted at the following link: https://www.altarum.net/survey/qmrfc.aspx .  Comments will be accepted until December 31, 2010. For a more detailed description of each measure concept, please see the following attachment, Measure Concept List – Detailed Descriptions [PDF - 105 KB] .

Your comments will inform the work of the HIT Policy Committee in supporting the development of HIT-sensitive clinical quality measures; these comments are important to shaping public policy on the future of e-measure development. Your responses are greatly appreciated.

Thank you.

David Lansky, Chair

Quality Measures Workgroup

Now the HITPC has asked us to look more deeply into some of the options for “who and how” and we would appreciate further public input on any or all of the following questions.  We encourage commenters to look at our “9 principles for sound governance [PDF - 95 KB]” and the recommendations [PPT - 1.7 MB] presented to the HITPC last week as a framework for their suggestions.  For example, the principles of sound governance include representative governance, a federated approach, and devolution; and the Workgroup has recommended that there be a “governance of governances” approach.

Here are a few key questions on which we’d like public input. Comments on specific recommendations are also welcome.

Federal role:

• What governance activities require a tight hold as a federal responsibility?
• What should be delegated? 

Validation role:

• Assumptions:
  •  there will be a variety of potential validation approaches, with potential options including but not limited to certification of technology and accreditation of entities;
  • some types of validation may not require formal certification or accreditation, but do need oversight.
  • existing validation entities and processes should be leveraged.
• Should there be an overarching validation entity to accredit other certification and/or accreditation bodies and monitor non-certification/accreditation processes to identify inconsistencies and issues?  

Coordination/Implementation support role

• Are there critical needs for “what needs to be governed” (from HITPC preliminary recommendations) that require a coordinating/implementation support governance mechanism be established in the near-term?
  • If so, should this coordination/implementation support role be done by using Federal Advisory Committees, or through public/private or non-governmental approaches?  

We would appreciate receiving comments by December 8^th. 

Governance is a huge and complex issue. It deserves ample, careful consideration. The WG looks forward to additional input from the public to shape its recommendations to the HITPC on December 13^th. There will be one or more public WG meetings by teleconference. Visit http://healthit.hhs.gov/FACAs/governancewg for more information about dates and how to participate.  

John Lumpkin, M.D., M.P.H.

Governance WG Chair

We would appreciate receiving comments as soon as possible and no later than November 3.

Recommended Governance Functions include:

(For more details, see the Recommendations report [PDF – 94 KB] presented to the HIT Policy Committee)

I. Establish policies for privacy, security, interoperability and to promote adoption of the NW-HIN.

a. Privacy and Security

b.  Interoperability, Eligibility Criteria and Compliance Expectations

c.  Address gaps; coordinate stakeholder input

d. Coordinate with technical and validation bodies

II. Establish technical requirements to assure policy and technical interoperability.

a. Adopt requirements

b. Coordinate with policy setting body

c. Change and transition process

d. Recognize or authorize shared technical services

III. Establishing appropriate mechanisms to assure compliance, accountability and enforcement.

a. Determine eligibility

b. Evaluate compliance

c. Assure accountability

d. Enforce

IV. Oversight of the governance mechanisms.

a. Track issues

b. Monitor ongoing compliance

c. Assess risks and benefits to prevent harm

d. Evaluate effectiveness

e. Resolve disputes