Blumenthal Letter #10: Proposed Rule for the Establishment of Certification Programs for Health IT

Blumenthal Letter #10:
Proposed Rule for the Establishment of Certification Programs for Health Information Technology

Dr. David Blumenthal


Message  from Dr. David Blumenthal, National Coordinator for Health Information Technology
March 2, 2010
  (emailed message) 

Today the Secretary of the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (NPRM) outlining the proposed approach for establishing a certification program to test and certify electronic health records (EHRs). The HITECH Act mandates the development of a certification program which will give purchasers and users of EHR technology assurances that the technology and products have the necessary functionality and security to help meet meaningful use criteria. While we are making significant strides toward modernizing our health care system, these efforts will only succeed if providers and patients are confident that their health information systems are safe and functional. 

The proposed rule incorporates two phases of development for the certification program to ensure that eligible professionals and eligible hospitals are able to adopt and implement Certified EHR Technology in time to qualify for meaningful use incentive payments. The rulemaking process will take time, so this phased approach provides a bridge  to detailed guidelines to support an ongoing program of testing and certification of health IT. 

The first proposed program creates a temporary certification process under which the National Coordinator would authorize organizations to assume many of the responsibilities that will eventually be fulfilled under the permanent certification program. For the permanent certification program, the rule proposes transitioning much of the responsibility for testing and certification to organizations in the private sector. 

Publication of the proposed rule on the Establishment of Certification Programs for Health Information Technology is an important first step in bringing structure and cohesion to the evaluation of EHRs, EHR modules, and potentially other types of health IT.  The programs will help support end users of certified products, and ultimately serve the interests of each patient by ensuring that their information is securely managed and available where and when it is needed. 

Your input is essential to bringing this important process to fruition.  We encourage your participation in the open public comment period.  

Additional information on both of these programs and how you can comment can be found through the HHS news release issued today and at the http://HealthIT.HHS.Gov website. 

The vision of the HITECH Act is unfolding rapidly, and all of us at ONC look forward to continuing to work with you to achieve the meaningful use of EHRs. 

Sincerely,
David Blumenthal, M.D., M.P.P.
National Coordinator for Health Information Technology
U.S. Department of Health & Human Services 


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Chopra Invites Feedback on Opportunities, Challenges facing HIT Implementation: FACA Blog

Aneesh Chopra Invites You to Tell Us About Opportunities and Challenges facing HIT Implementation: Federal Advisory Committee Blog
On Feb 12, 2010 post on FACA Blog, US CTO and Implementation Workgroup Chair Aneesh Chopra invited feedback and HIT success stories in preparation for ”March 8th, the Implementation Workgroup of the Health IT Standards Committee (which) will hold a public hearing on ‘Implementation Starter Kit: Lessons and Resources to Accelerate Adoption’ to help providers achieve meaningful use by, in part, surfacing examples of effective meaningful use implementation preparation.”

Chopra continues “Although any comment or question is welcome, we are particularly interested in questions or comments about the four categories of standards:

  1. Vocabulary Standards (i.e., standardized nomenclatures and code sets used to describe clinical problems and procedures, medications, labs and allergies);
  2. Content Exchange Standards (i.e., standards used to share clinical information such as clinical summaries, prescriptions, and structured electronic documents);
  3. Transport Standards (i.e., standards used to establish a common, predictable, secure communication protocol between systems); and
  4. Privacy and Security Standards (e.g., authentication, access control, transmission security) which relate to and span across all of the other types of standards. “

While feedback on the blog is “not a substitute for official feedback on the regulations” due March 15, 2010, it will help guide the Implementation meeting.

HIT Policy and Standards Committee Workgroups’ Deliberations to be Made Publicly Available

HIT Policy and Standards Committee Workgroups’
Deliberations to be Made Publicly Available

Excerpted from email notice of Jan 25, 2010

“In the interest of transparency, starting in January 2010, the Office of the National Coordinator for Health IT (ONC) is making available to the public the HIT Policy Committee and the HIT Standards Committee workgroups’ deliberations.  

“All workgroup meetings will be available via webcast; for instructions on how to listen via telephone or Web visit http://healthit.hhs.gov. (Note that the majority of the workgroups’ meetings will be available both via phone or web, except when indicated otherwise.)

“Please check the ONC website for additional information as it becomes available since any last minute additions or modifications to previously announced workgroup meetings cannot always be published in the Federal Register to provide timely notice.

“In addition, audio files (.mp3) of FACA Committee meetings and the workgroup meetings will be available on the ONC website within 24 to 48 hours following the conclusion of each meeting.  A draft transcript of the meetings will be available within 5 to 8 business days. All transcripts will be marked and considered “draft” until they are reviewed and approved by the committee or workgroup members.” 

Contact Person: Judy Sparrow, Office of the National Coordinator,  email: judy.sparrow@hhs.gov  Please reach the contact person or visit the ONC website for up-to-date information on these meetings.
###

HIT Policy Committee Meetings Page
HIT Standards Committee Meeting Page

Blumenthal Letter #8: Standards and Certification Criteria to Support Meaningful Use of Electronic Health Records

Dr. David Blumenthal

Emailed December 30, 2009

A Message from Dr. David Blumenthal, National Coordinator for Health Information Technology

As we look toward 2010, we can envision a transformation of our health system to improve health care quality, efficiency, equity, and safety through the use of health information technology (HIT), while providing the foundation for continued, measurable improvement in our nation’s health.  The adoption and meaningful use of information technology in health care is central to a necessary and overdue modernization of our health system. 

As required by the HITECH Act, the Secretary of the Department of Health and Human Services (HHS) has published an initial set of standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health information technology.  These criteria are outlined in the interim final rule (IFR) on Standards & Certification Criteria issued today by the Office of the National Coordinator for Health Information Technology (ONC).  

The IFR provides details on requirements for “certified” electronic health record (EHR) systems, and the technical specifications needed to support secure, interoperable, nationwide electronic exchange and meaningful use of health information. 

In a related announcement, the Centers for Medicare & Medicaid Services (CMS) issued a notice of proposed rulemaking (NPRM) that outlines provisions governing the Medicare and Medicaid EHR incentive programs, including a proposed definition for the central concept of “meaningful use” of EHR technology.  In order for professionals and hospitals to be eligible to receive payments under the incentive programs, provided through the Recovery Act, they must be able to demonstrate meaningful use of a certified EHR system.  The proposed standards and certification criteria in the IFR are fundamentally linked to and specifically designed to support the 2011 meaningful use criteria.

Great care was taken in the development of these criteria, with input from the public and federal advisory committees every step of the way.  The resulting standards and certification criteria in the IFR are organized into four categories as recommended by the HIT Policy Committee and HIT Standards Committee:

  • Content Exchange Standards (i.e., standards used to share clinical information such as clinical summaries, prescriptions, and structured electronic documents);
  • Vocabulary Standards (i.e., standard nomenclature used to describe clinical problems and procedures, medications, and allergies);
  • Transport Standards (i.e., standards used to establish the communication protocol between systems); and
  • Privacy and Security Standards (e.g., authentication, access control, transmission security/encryption) which relate to and span across all of the other types of standards.

While well-defined data and technical standards are the foundation for interoperability between systems – allowing for reliable, consistent, secure, and accurate information exchange – we recognize that a high-level of nationwide interoperability will take time and will occur at varying rates.  Therefore, our approach to the adoption of standards and certification criteria is pragmatic, yet forward looking.  The criteria are designed to be supportive of the staged meaningful use requirements, but at the same time lay the foundation for future growth in information exchange and technological innovation.

An incremental approach to standards adoption requires harmonization with current and future standards to come.  We will continue to be guided by recommendations from our federal advisory committees, public comment, industry readiness, and future meaningful use goals and objectives established for the Medicare and Medicaid EHR incentive programs.  We anticipate this ongoing evolution in standards and certification criteria development as meaningful use requirements become more demanding over time and as industry continues to spur adoption through its innovative offerings.

Now, we ask for your continued input to inform the final regulations due in 2010.

Additional information on both of these regulations and how you can contribute to the open public comment periods can be found through the HHS news release issued today and at the http://HealthIT.HHS.Gov website.

At ONC, we look forward to your continued and active participation in HITECH programming and ongoing rulemaking processes in the new year.

Sincerely,
David Blumenthal, M.D., M.P.P.
National Coordinator for Health Information Technology
U.S. Department of Health & Human Services

The Office of the National Coordinator for Health Information Technology (ONC) encourages you to share this information as we work together to enhance the quality, safety and value of care and the health of all Americans through the use of electronic health records and health information technology.

For more information and to receive regular updates from the Office of the National Coordinator for Health Information Technology, please subscribe to our Health IT News list.

END OF eMAIL UPDATE

HITECH Funding Opportunities from ONC

HITECH Funding Opportunities from ONC
These are the eight funding programs from the Office of National Coordinator (ONC) for Health IT. Excerpted from ONC Web site on Dec 22, 2009. Links for upcoming technical assistance calls or slides and transcripts where available.

Currently Available Funding Opportunities
Health Information Technology Extension Program (cycle 2)
Objective: This program provides grants for the establishment of Health Information Technology Regional Extension Centers that will offer technical assistance, guidance and information on best practices to support and accelerate health care providers’ efforts to become meaningful users of Electronic Health Records (EHRs).
Application Deadline: 
Cycle 1: Full Applications – November 3, 2009
Cycle 2: Preliminary Applications – December 22, 2009; Full Applications – January 29, 2010 

Curriculum Development Centers
Objective: 
This funding opportunity, one component of the Health IT Workforce Program, will provide $10 million in grants to institutions of higher education (or consortia thereof) to support health information technology (health IT) curriculum development.
Application Deadline:  January 14, 2010 (Letter of Intent due January 4, 2010)
See slides and transcript from Dec 17, 2009 technical assistance call.

Community College Consortia to Educate Health Information Technology Professionals
Objective:
This program, one component of the Health IT Workforce Program, seeks to rapidly create health IT education and training programs at Community Colleges or expand existing programs.  Community Colleges funded under this initiative will establish intensive, non-degree training programs that can be completed in six months or less.
Application Deadline:  January 22, 2010 (Letter of Intent due January 6, 2010)
Slides and Transcript from Technical Assistance Call Dec 16, 2009.

Program of Assistance for University-Based Training
Objective:  The purpose of this program, one component of the Health IT Workforce Program, is to rapidly increase the availability of individuals qualified to serve in specific health information technology professional roles requiring university-level training.  
Application Deadline:  January 25, 2010 (Letter of Intent due January 6, 2010)
Technical Assistance call on Dec 23, 2009 at 2:00 pm and Jan 5, 2009 at 3:00 pm EST plus Slides from Dec 23 call.

Competency Examination for Individuals Completing Non-Degree Training
Objective:
  This funding opportunity, one component of the Health IT Workforce Program, will provide $6 million in grants to an institution of higher education (or consortia thereof) to support the development and initial administration of a set of health IT competency examinations.
Application Deadline:  January 25, 2010 (Letter of Intent due January 8, 2010)
Technical Assistance Call on Jan 6, 2010 at 1:00pm EST. Details to come.

Strategic Health IT Advanced Research Projects (SHARP) Program
Objective:  The purpose of these awards is to fund research focused on achieving breakthrough advances to address well-documented problems that have impeded adoption: 1) Security of Health Information Technology; 2) Patient-Centered Cognitive Support; 3) Healthcare Application and Network Platform Architectures; and, 4) Secondary Use of EHR Data.
Application Deadline:  January 25, 2010 (Letter of Intent due January 4, 2010)
Technical Assistance Call: Dec 22, 2009, and Jan 4, 2010 at 2:30 pm plus Slides from Dec 22 call.

Beacon Community Cooperative Agreement Program
Objective:
  This program will provide funding to communities to build and strengthen their health information technology (health IT) infrastructure and exchange capabilities to demonstrate the vision of meaningful health IT.
Application Deadline:  February 1, 2010 (Letter of Intent due January 8, 2010)
Slides and Transcript from Technical Assistance Call Dec 14, 2009.
 
Closed Funding Opportunities (Pending Award)
State Health Information Exchange Cooperative Agreement Program
These grant programs will support states and/or State Designated Entities (SDEs) in establishing health information exchange (HIE) capacity among health care providers and hospitals in their jurisdictions. Such efforts at the state level will establish and implement appropriate governance, policies, and network services within the broader national framework to rapidly build capacity for connectivity between and among health care providers. State programs to promote HIE will help to realize the full potential of EHRs to improve the coordination, efficiency, and quality of care.
Awards expected in early 2010.

New Privacy & Security Workgroup Presents Charge and Members

Privacy & Security Policy Workgroup
of HIT Policy Committee

The new Privacy & Security Policy Workgroup foimed by the HIT Policy Committeee will work in coordination with the Privacy & Security Workgroup of the Standards Committee. Below is draft of workgroup’s basic charge and members as presented in HIT Policy Committee on December 15, 2009. Excerpted from ONC Web site.

Charge – DRAFT
“To make recommendations to the Health IT Policy Committee on privacy and security policies and practices that will help build public trust in health information technology and electronic health information exchange. Specifically, the workgroup will seek to address complex privacy and security challenges through the development of proposed solutions and approaches that enhance privacy and security while also facilitating the appropriate access, use and exchange of health information to improve health outcomes.”

Workgroup Members
Deven McGraw, Chair
Center for Democracy & Technology

Rachel Block, Co-Chair
NYS Department of Health

Dixie Baker, SAIC
Peter Basch, Provider
A. John Blair, Provider
Marianna Bledsoe, NIH
Joyce DuBow, American Association of Retired Persons
Paul Egerman, Consultant
Judy Faulkner, Epic, Inc.
Justine Handelman, Blue Cross Blue Shield
Gayle Harrell, Consumer Representative/Florida
John Houston, University of Pittsburgh Medical Center
Mike Klag, Johns Hopkins University, Public Health
Terri Shaw, Children’s Partnership
Latanya Sweeney, Carnegie Mellon University
Paul Tang, Palo Alto Medical Foundation
Paul Uhrig, SureScripts
David Wanser, NDIIC
Kathleen Connor, MicroSoft

HIT Policy Cmte Materials: Dec 15, 2009

HIT Policy Committee Materials: Dec 15, 2009
Location:
Washington, DC
Time:
9 a.m. to 2:45 p.m. EST 

For timed agenda, Webcast and call-in number, see earlier post on e-Healthcare Marketing.

HIT Policy Committee Dec 15 Agenda:NHIN, Privacy & Security, Meaningful Use, Health Plans

HIT Policy Committee Agenda: NHIN, Privacy & Security, Meaningful Use, Health Plans To Testify
December 15, 2009

9:00 a.m. to 2:45 p.m. [Eastern Time]
Washington, DC

A G E N D A   (pdf version)
9:00 a.m. CALL TO ORDER – Judy Sparrow
Office of the National Coordinator for Health Information Technology
9:05 a.m. Opening Remarks – David Blumenthal, MD, MPP, National Coordinator for Health Information Technology
9:15 a.m. Review of the Agenda – Paul Tang, Vice Chair of the Committee
9:20 a.m. Briefing on the ONC Agenda
- David Blumenthal, National Coordinator for Health Information Technology
9:45 a.m. Meaningful Use Workgroup Update
- Paul Tang, Chair
- George Hricpsak, Co-Chair
9:55 a.m. Certification/Adoption Workgroup Update
- Paul Egerman, Co-Chair
- Marc Probst, Co-Chair
10:00 a.m. Information Exchange Workgroup Update & Recommendations
- Deven McGraw, Chair
- Micky Tripathi, Co-Chair
10:30 a.m. NHIN Workgroup: Membership, Scope
- David Lansky, Chair
- Danny Weitzner, Co-Chair
Privacy & Security Policy Workgroup: Membership, Scope
- Deven McGraw, Chair
- Rachel Block, Co-Chair
Strategic Plan Workgroup: Membership, Scope
- Paul Tang, Chair
- Jodi Daniel, Co-Chair
11:45 a.m. LUNCH BREAK
12:30 p.m. Panel on Health Plans
- Charles Kennedy, WellPoint
- Julie Klapstein, CEO, Availity
- Andrew Slavitt, CEO, Ingenix
- Catherine MacLean, WellPoint
- Andrew Wiesenthal, Kaiser Permanente
2:00 p.m. Briefing from the HIT Standards Committee
- Dixie Baker, Privacy & Security Workgroup|
- Aneesh Chopra, Implementation Workgroup
2:30 p.m. Public Comment
2:45 p.m. Adjourn

To participate by Web or Telephone
Webconference (test prior to meeting)
Audio: 
US toll free:   1-877-705-6006
International Direct:  1-201-689-8557
Confirmation Code: HIT Committee Meeting

For NHIN Agenda on Dec 16, 2009 see earlier post on e-Healthcare Marketing.

More News on Security and Implementation from HIT Standards Committee Nov 19, 2009

More News on Security and Implementation
from HIT Standards Committee Nov 19, 2009
Health IT panel to heed calls for simpler EHR standards
Government Health IT‘s Mary Mosquera reported on November 19, 2009, that the Standards Committee ”will heed the overwhelming consensus it has received in recent public comments to develop the simplest possible certification standards for accelerating health IT adoption.” Committee vice chair John Halamka commented that he thought changes in committee recommendations would impact requirements starting in 2013, and not the initial 2011 standards to share medication lists, medical problems, allergies, and lab reports.

Current security standards too complex, expert says
In his Nov 20, 2009 report, Joseph Conn, HITS/ModernHealthcare, quotes Peter Tippett
, vp of technology and innovation and chief medical officer for Verizon, extensively, as one of more than 12 security experts who testified at the Nov 19, 2009 HIT Standards Committee meeting.  Tippett argued for a more risk-based exception approach. HIMSS Lisa Gallager’s testimony on HIMSS latest security survey was described as well.

Standards group offers 10 guidelines to make HIT adoption easier
Diana Manos, Healthcare IT News, reported on November 20, 2009,
on the ten guidelines developed by HIT Standards Committee to encourage HIT adoption based on testimony and other public feedback.

Report from Halamka’s Life as a Healthcare CIO
John Halamka reported on the both the implementation and security issues discussed at the Standards Committee meeting on November 19, 2009.
 Halamka’s recap includes some of the security portion’s ”Gold Star” ideas on stability/reliability, cybersecurity, data theft/loss/misuse, and building trust.

Health agency execs explore network security boundaries, performance
Mary Mosquera, Government HealthIT reported November 20, 2009, from the prior day’s HIT Standards Committee “‘Many of the government mandated standards are more stringent than their commercial equivalents,’ said Michael Mellor, deputy chief information security officer for the Centers for Medicare and Medicaid Services.” This was part of the discussion on security and interoperability standards.

e-Healthcare Marketing post prior to HIT Standards Committee Meeting on the Ten Recommendations for Implementation/Adoption.
e-Healthcare Marketing post prior to HIT Standards Committee Meeting with Documents to be discussed.

EHR Implementation/Adoption Learnings: HIT Workgroup

EHR Implementation/Adoption: HIT Workgroup
Review of the Adoption Experience Hearing
Review to be presented November 19, 2009 of the Implementation/Adoption Workgroup Oct 29 meeting and followup by Aneesh Chopra, Workgroup Chair and Office of Science &  Technology; Judy Murphy, Workgroup Member and Aurora Health Care; and Cris Ross, Workgroup Member and CVS/MinuteClinic.
See Nov 19, 2009 meeting post for slide set.
Excerpted from slide set.

Top Ten Recommendations from the Implementation/
Adoption Experience Hearing on 10/29/09

1. Keep it simple.
          –Think big, but start small. –Recommend standards as minimal as required to support a necessary policy objective or business need, and then build as you go
2.  Don’t let “perfect” be the enemy of “good enough”
          –Go for the 80 percent that everyone can agree on
          –Get everyone to send the basics (meds, problems, allergies, labs) before focusing on the more obscure
3.   Keep the implementation cost as low as possible
          –Minimize the costs associated with implementation of standards, including royalties, licensing fees and other expenses
          –Open the NIST interoperability certification testing processes
4.  Design for the little guy
          –Make sure the endorsed standards are as broadly implementable as possible, so diverse participants can adopt it, and not only the best-resourced
5.  Do not try to create a one-size-fits-all standard
          –Do not mandate or attempt to create a one-size-fits-all standard that adds burden or complexity to the simple use cases
6.  Separate content and transmission standards.
          –Separate content standards from transmission standards; i.e., if CCD is the html, what is the https?
          –Separate the network layer from the application layer.
          –Avoid linking changes between senders and receivers.
7. Create publicly available  vocabularies & code sets
          –Ensure they are easily accessible and downloadable, with straightforward means to update or upgrade.
8. Leverage the web for transport (“health internet”).
          –Use what already works in transporting information securely on the internet.
          –Decrease complexity as much as possible to shorten the learning curve of implementers.
9. Position quality measures so they  motivate standards adoption.
          –Strive for quality reporting to be an automated by-product of using certified technology and standards, lowering the administrative burden of reporting to the lowest extent possible.
10. Support implementers
          –Make Implementation Guides available that are human readable, with working examples and testing tools.
          –Facilitate implementers’ use of Implementation Guides with effective national communication plans.
          –Publish open source reference implementations.

Conclusions
Substantial concern about the state of the EHR
          –Difficulties improving economics, quality, or productivity
          –We are not building on a firm legacy of success, we are looking for a pathway to success
Think big, start small, move fast
          –Thinking for future adopters and innovators is important
          –Corresponding concern that the work that has gone into complex standards will be lost
Separate content from transport
          –“Get SDOs out of the business of creating HTTP”
Combine the best of Internet and Informatics thinking

Question
Are complex solutions the best answer to complex problems?

Blog Comments
Federal Advisory Committee Blog
http://healthit.hhs.gov/blog/faca

Non-governmental blogs with related content
Sean Nolan’s blog:  http://blogs.msdn.com/familyhealthguy
Wes Rishel’s blog:  http://blogs.gartner.com/wes_rishel
John Halamka’s blog:  http://geekdoctor.blogspot.com
Adam Bosworth’s blog:  http://adambosworth.net
The Health Care Blog:  www.thehealthcareblog.com

From Dr. John Halamka – for discussion by the
HIT Standards Committee & Implementation Workgroup members
1. Work hard on vocabularies
and try to get them open sourced for the entire community of stakeholders
2. Consider adding a simple REST-based transport method for point to point exchanges between organizations
3. Work jointly with the HIT Policy Committee to establish a privacy framework that enables us to constrain the number of security standards
4. As we continue our work, try to use the simplest, fewest standards to meet the need
5. Continue to gather feedback on the 2011 exchanges (ePrescribing, Lab, Quality, Administrative)
to determine if there are opportunities to enhance testing platforms and implementation guidance that will accelerate adoption