Friday, July 30, 2010

FCC and FDA Joint Meeting on Life Saving Wireless Medical Technology

The Food and Drug Administration (FDA) and the Federal Communications Commission (FCC) signed a memorandum of understanding committing the agencies to coordinated oversight of medical devices in view of the rapid convergence of network and healthcare technologies.

They two agencies released a joint statement stating:

  1. Innovation in broadband and wireless-enabled medical devices holds significant promise for enhancing health and reducing the costs of health care for all Americans. Examples include wireless sensors that remotely monitor heart rhythm and portable glucose monitoring systems. All Americans should be afforded the opportunity to benefit from medical technology advances with improved broadband and wireless technology.
  2. Developing and integrating wireless and broadband communications technology with medical devices and applications requires agencies to assure that such devices operate in a safe, reliable and secure manner.
  3. It is important for the federal government to provide leadership and encourage innovation and investment in new health care technologies that enable patients, doctors, and other health professionals to access the highest quality care.
  4. The American public -- including industry, providers, patients, and other interested stakeholders -- should have clear regulatory pathways, processes, and standards to bring broadband and wireless-enabled medical devices to market. This includes clarity regarding each agency’s scope of authority with respect to these devices, predictability regarding regulatory pathways, and streamlining the application process, as appropriate, to facilitate innovation while protecting patients.
  5. The FDA and the FCC agree to build upon this initiative launched today to proactively serve the national interest in finding innovative solutions to America’s health care challenges.

They held an unprecedented joint meeting on "Life Saving Wireless Medical Technology" on July 26-27, 2010 (video for both days is below). The purpose of these meetings was for the FDA and FCC to gain a better understanding of the convergence of communications technologies and medical devices, the future of wireless health technologies, and the challenges they face. Our goal is to enhance coordination between FDA and FCC for future devices and applications, and to clarify and delineate the respective areas of expertise and jurisdiction between the agencies. The meetings marked the beginning of a process through which the agencies will provide appropriate clarifications in the future based on the input gathered.
"This joint initiative reflects a shared commitment on behalf of the FCC and FDA to promote investment and innovation in the health technologies that will save lives and help address some of our nation’s health care challenges,” said FCC Chairman Julius Genachowski. “I enthusiastically support this effort and applaud the teams in place at the FCC and the FDA working diligently to ensure that these medical innovations can safely and swiftly be brought to market."

Day 1 - July 26, 2010
8:00 a.m. Check In & Vendor Showcase Opens
Chairman Genachowski and Commissioner Hamburg will be joined by Aneesh Chopra, Chief Technology Officer, to tour the showcase
9:00 a.m. Welcome
Julius Knapp
Chief, Office of Engineering and Technology, FCC
9:15 a.m. Opening Remarks
Julius Genachowski, JD
Chairman, Federal Communications Commission

Margaret Hamburg, MD
Commissioner, Food and Drug Administration
Each session will begin with a brief presentation made by three to four round table members followed by a round table discussion led by moderators.

9:35 a.m. Session 1: Current State of Wireless Health and Lessons Learned (45 min)
Understanding the variety of existing wireless medical technologies, their uses, and lessons learned.
Moderators: Jeffrey Shuren, MD and Julius Knapp

Presentations: (5 minutes each)

Dale Wiggins Chief Technology Officer, Philips
Charles S. Farlow Senior Program Manager, Medtronic
Jorge Valdes Chief Technical Officer, DexCom
Elliot B. Sloane Professor and Director of Health Systems Engineering, Drexel University School of Biomedical Engineering
Round Table Discussion

10:20 a.m. Break & Visit Showcase (40 min)


The objective of these sessions is to better understand the landscape of emerging wireless medical technologies and trends, their potential benefits, potential risks, and challenges from various stakeholder perspectives.

11:00 a.m. Session 2: Innovator Perspective (1 hour 15 min)
Moderators: Steve Pollack and Julius Knapp

Presentations: (5 minutes each)

Hillary Chen Global Health Advisor to the Deputy Director (White House OSTP)
Don Jones VP Business Development, Health & Life Sciences, Qualcomm Inc.
Tim Kottak Executive, Design Controls, GE Healthcare
David L. Hankin CEO, Alfred E. Mann Foundation for Scientific Research
Round Table Discussion

12:15 p.m. Lunch & Visit Showcase (1 hour 30 min)
1:45 p.m. Session 3: Healthcare Provider, Clinician & Patient Perspective (1 hour 15 min)
Moderators: Bakul Patel and Kerry McDermott

Presentations: (5 minutes each)

Adam Darkins, MD Chief Consultant for Care Coordination, Veterans Affairs
Col. Ron Poropatich, MD Deputy Director, TATRC, USAMRMC
Julian Goldman, MD Medical Director, Biomedical Engineering, Partners HealthCare; Attending Anesthesiologist, Massachusetts General Hospital
Round Table Discussion

3:00 p.m. Break (15 min)
3:15 p.m. Session 4: Investor and Research & Development Perspective (1 hour 15 min)
Moderators: Jonathan Sackner-Bernstein, MD and Phoebe Yang

Presentations: (5 minutes each)

Darren Hite Principal, Aberdare
Joseph Smith, MD, PhD Chief Medical and Science Officer, West Wireless Health Institute
Kaveh Safavi, MD Vice President and Global Lead, Cisco Internet Business Solutions Group - Healthcare Practice
Round Table Discussion

4:30 p.m. Public Comments (45 min)
Attendees will be allowed to make a statement based on advance sign-up. Preference will be given to those individuals that indicated a desire to speak during the registration process. Each speaker will be allowed a maximum of two minutes.
5:15 p.m. Wrap Up – Summarize Day 1 and Preview Day 2
5:30 p.m. Adjourn

Day 2 - July 27, 2010
8:30 a.m. Doors open
9:00 a.m. Welcome and Opening Remarks
Julius Knapp
Chief, Office of Engineering and Technology, FCC
9:10 a.m. Session 5: Reliability – How to Define Quality of Service (1 hour 15 min)
Better understanding the issues raised by use of commercial networks and unlicensed spectrum for health purposes.

Moderators: Abiy Desta and Tom Peters

Presentations: (5 minutes each)

Peter Koo Vice President, Strategic Business Development, Ericsson
Neal Seidl Design Controls Manager, GE Healthcare
Tom Watlington CEO, Sotera Wireless
Round Table Discussion

10:25 p.m. Break (15 min)
10:40 a.m. Session 6: Electromagnetic Compatibility – How to Promote EMC (1 hour 15 min)
Better understanding how wireless health devices interact and how to ensure that such devices function properly.

Moderators: Brian Beard and Rashmi Doshi

Presentations: (5 minutes each)

Jim McCoy Chief Technology Officer, InnerWireless
Rick Hampton Wireless Communications Manager, Partners Healthcare System
Terry Mahn Managing Principal, Fish & Richardson
Round Table Discussion

11:55 a.m. Public Comments (45 min)
Attendees will be allowed to make a statement based on advance sign-up. Preference will be given to those individuals that indicated a desire to speak during the registration process. Each speaker will be allowed a maximum of two minutes.
12:40 p.m. Wrap Up – Summarize Learnings, Areas for Focus & Next Steps
1:00 p.m. Adjourn

Round Table Discussion Participants – July 26, 2010
Session 1
Bernie Liebler – AdvaMed
Bonnie Norman – Intel
Kent Dicks – MedApps
Tom Watlington – Sotera Wireless
Session 2
Bernie Liebler – AdvaMed
Jorge Valdes – DexCom
Elliot Sloane, PhD – Drexel University
Bonnie Norman – Intel
Kent Dicks – MedApps
Dale Wiggins – Philips
Tom Watlington – Sotera Wireless
Session 3
Mike Tilkin – American College of Radiology
Chantal Worzala, PhD – American Hospital Association
Neal Sikka, MD – George Washington University Medical Center
Campell Hutton – Juvenile Diabetes Research Foundation (JDRF)
Bill Riley, PhD – National Heart, Lung, and Blood Institute
Stephanie Bruce, MD – Washington Hospital Center
Session 4
Jeffrey Dygert – AT&T
Blair Levin – Aspen Institute
Nancy Kamei – Intel
Philip Low, PhD – NeuroVigil, Inc.
John Maschenic – Verizon
Round Table Discussion Participants – July 27, 2010
Session 5
David Hankin – Alfred Mann Foundation
Jake Leach – DexCom
Audie Atienza, PhD – National Institutes of Health
PDale Wiggins – Philips
Dean Brenner – Qualcomm
Kevin Fu – University of Massachusetts
Session 6
John Collins – American Society for Healthcare Engineering (ASHE) of the AHA
Troy Nagle, MD, PhD – NC State U. & UNC Chapel Hill
Ken Fuchs – Draeger Medical Systems
PDale Wiggins – Philips
Ted Osiniski – MET Labs


Thursday, July 29, 2010

Government Documents - by the people, for the people

People have asked me why I use Scribd and Slideshare for public documents instead of just linking to government websites. Well, many times government websites are not that easy to navigate and the documents are sometimes scattered over disparate sites and I aggregate the information and try to make it more accessible. Also the actual links can change over time, so the link to a document from a government website today may no longer work in the future.

Today I came across a perfect example. Documents are posted to the OFR Public Inspection Desk at prior to their publication in the Federal Register. These documents still have some proof reading by the OFR before publications to correct typographical errors, etc. After publication the link no longer works.

For instance if you go to the ONC web pages on meaningful use you will see that they currently have broken links pointing to the old documents at the Public Inspection Desk: and

Now that the rule is published in the Federal Register the new link would be:

I've asked the ONC to fix the pages with the old links, and I'm sure they will, [UPDATE (8/30/2010) - they have fixed the links] but that is why since these are all public documents owned by the American people I usually choose to store them on a third party site to maintain the integrity of my links. Take a look at my post on the meaningful use final rules the day they were released ~ as noted the temporary links no longer work...

Wednesday, July 28, 2010

Meaningful Use Rules & Certification Criteria for EHRs

Karen Trudel, deputy director of the Office of E-Health Standards & Services at the CMS gave a status report July 28, 2010 to the Health IT Standards Committee. The presentation is below.

Tuesday, July 27, 2010

Energy and Commerce Committee Hearing on Health IT

The Subcommittee on Health of the House Energy and Commerce Committee held a hearing on Tuesday, July 27, 2010, in 2322 Rayburn House Office Building entitled “Implementation of the Health Information Technology for Economic and Clinical Health. Reported Emily Long at NextGov:
Members of the House Energy and Commerce Health Subcommittee questioned whether health care providers will run out and purchase new technology knowing that the certification program won't be up and running until 2012. Providers who don't demonstrate meaningful use by 2015 could face penalties.
According to Blumenthal, The Office of the National Coordinator has in place a temporary certification program, but it doesn't include all the criteria that providers will have to meet in the long run.The certification standards are entirely new because they must reflect the requirements of meaningful use, he said, adding, "We don't want to create the impression for providers that something they're using now will be capable of meaningful use."
Testifying at the hearing were:
  • David Blumenthal, M.D., National Coordinator, Health Information Technology, U.S. Department of Health and Human Services
  • Anthony Trenkle, Director, Office of E-Health Standards and Services, Centers for Medicare and Medicaid Services
  • Frank J. Vozos, M.D., FACS , Executive Director, Monmouth Medical Center, New Jersey Hospital Association
  • Gregory D. Starnes, CEO, Fayette County Hospital
  • Christine Bechtel, Vice President, National Partnership for Women & Families
  • Roland A. Goertz, M.D., M. B.A., President-Elect, American Academy of Family Physicians, Heart of Texas Community Health Center
  • Dr. Matthew Winkleman, M.D., Physician, Primary Care Group,
  • Glen E. Tullman, CEO, Allscripts
  • Peggy C. Evans, Ph.D., CPHIT, Director, Washington and Idaho Regional Extension Center, Qualis Health
The Briefing Memo is below with video and testimony beneath that and then some interesting bits from the question and answer. The entire hearing is embedded at the end of the post.

Testimony of David Blumenthal

Testimony of Anthony Trenkle

Testimony of Frank J. Vozos

Testimony of Gregory D. Starnes

Testimony of Christine Bechtel

Testimony of Roland A. Goertz

Testimony of Matthew Winkleman

Testimony of Glen E. Tullman

Testimony of Peggy C. Evans

Below are some interesting segments from the Q and A.



Sunday, July 25, 2010

Liberating the NHS

As the Unites States moves towards a more centralized government role in healthcare, Great Britain is beginning to move in the other direction. The new coalition government has proposed some quite radical plans for the National Health Service (NHS) by shifting control of the $160 billion annual health budget from a centralized bureaucracy to local physicians while also promising to put more power in the hands of patients.

The paper (embedded below) states:
"The current architecture of the health system has developed piecemeal, involves duplication and is unwieldy. Liberating the NHS, and putting power in the hands of patients and clinicians, means we will be able to effect a radical simplification, and remove layers of management."
Some of the main points in the paper include:
  • The retention of national and regional commissioning, which will come under a new NHS Commissioning Board
  • The recognition that research is vital in order to identify new ways of preventing, diagnosing and treating disease
  • The commitment to shared decision making and the recognition that it results in a better quality of care
  • Increased patient access to information, including increased control over their records and more information on research
  • Integration of health and social care by creating a system that works more effectively across boundaries

Thursday, July 22, 2010

eHI Releases "The State of Health Information Exchange in 2010: Connecting the Nation to Achieve Meaningful Use"

The eHealth Initiative (eHI) released a new report entitled "The State of Health Information Exchange in 2010: Connecting the Nation to Achieve Meaningful Use." The report identifies significant growth in the industry, as well as rising concerns related to new government policies, and an increased focus on patients. The report was shared with several hundred state and industry leaders during the National Forum on Health Information Exchange in Washington, DC. The eHealth Initiative has been tracking the progress of health information exchange initiatives for seven years. This year, eHI identified 234 active health information exchange initiatives across the country and 199 organizations responded to the annual survey.

Several key findings emerged from the survey results:

Despite recent funding, significant challenges exist to supporting provider attainment of meaningful use.

The survey revealed that despite expanding capabilities, the ability of HIEs to support providers as they become Stage 1 meaningful user will be challenged by the current number of operational exchanges and current capacity of health information exchange initiatives.

"From the results, it is clear that health information exchange initiatives are focused on supplying the services that will help providers reach their targets," Commented Micky Tripathi, Ph.D., President and CEO of Massachusetts eHealth Collaborative. "While we're on the right track with the service offerings, we still haven't achieved the necessary critical mass of participation."

More research is needed to determine the key characteristics of sustainable systems.

The report confirms that sustainability remains one the key challenges before the initiatives. The State Designated Entities (SDEs) are new entrants in the field, and it is not clear what will be their impact on the initiatives.

"The State Designated Entities (SDEs) are poised to foster growth across the field of health information exchange," said Dr.Marc Overhage, Director of Regenstrief Institute and CEO of Indiana Health Information Exchange. "Among other challenges, the SDEs are going to face the question how to keep the doors open once the federal funding ends. Failure to sustain the SDEs may hinder the overall advancement of health information exchange."

New challenges are rapidly emerging related to federal policy and governance of the health information exchanges.

131 initiatives cited addressing government policy mandates as a major challenge.

More organizations are reporting cost savings through reductions in staff time and redundant testing through the use of health information exchange.

More initiatives reported health information exchange had reduced staff time spent on clerical administration and filing (33); reduced staff time spent on handling lab and radiology results
(30); and decreased dollars spent on redundant tests (28).

Health information exchange initiatives have increased their focus on patients.

Initiatives are providing greater access to patients to not only view (44 in 2010 up from 3 in 2009), but to also update their health information (31 in 2010 up from 7 in 2009).

"There is definite progress here, but it doesn't mean we can rest on our laurels," noted Jennifer Covich Bordenick, CEO at eHealth Initiative. "More initiatives and providers need to document cost savings, and promote services that involve patients in their healthcare."

The report and an interactive map of health information exchange activity are available on the eHI website at:

The HIE I am working on, Gorge Health Connect, Inc. is here:

Open Source Solutions for Healthcare

With the health information technology industry ramping up to help physicians and hospitals meet meaningful use, there is opportunity to bring open source solutions to bear. At the intersection of health care, government and open source, these three have a unique perspective on how to address the pressing needs within health care.

If you have not had a chance to see the interview on Radar with Brian Behlendorf, Arien Malec and David Riley check it out at

Tuesday, July 20, 2010

Congressional Testimony on Meaningful Use

The House Ways and Means Subcommittee on Health held a Hearing on Efforts to Promote the Adoption and Meaningful Use of Health Information Technology on July 20, 2010. Text of the testimony provided at the meeting is below the videos:

Testimony By David Blumenthal M.D.

National Coordinator for Health Information Technology
U.S. Department of Health and Human Services

Testimony By Tony Trenkle

Office of E-Health Standards and Services
Centers for Medicare & Medicaid Services

Testimony By Christine Bechtel

Vice President
National Partnership for Women and Families

Testimony By Phyllis Teater

Chief Information Officer
Ohio State University Medical Center, Columbus, Ohio

Testimony By Eugene Heslin M.D.

Saugerties, New York

Testimony By Charles W. Jarvis

Vice Chair
Health Information and Management Systems Society (HIMSS)
Electronic Health Record Association (EHRA), Chicago, Illinois

Testimony By Jonathan P. Hare

Resilient Network Systems, Inc.,
San Francisco, California

Monday, July 19, 2010

OpenNotes© Study Launches

With patients across the country voicing a growing desire for greater engagement in and control over their medical care, a new study involving patients in Boston, Pennsylvania and Seattle will examine the impact of adding a new layer of openness to a traditionally one-sided element of the doctor-patient relationship—the notes that doctors record during and after patients’ visits.

Funded through a $1.4 million grant from the Robert Wood Johnson Foundation (RWJF) Pioneer Portfolio—which supports innovative ideas and projects that may lead to important breakthroughs in health and health care—the 12-month OpenNotes© project will evaluate the impact on both patients and physicians of sharing, through online medical record portals, the comments and observations made by physicians after each patient encounter. Approximately 100 primary care physicians and 25,000 patients at Beth Israel Deaconess Medical Center (BIDMC) in Boston, Geisinger Health System in Pennsylvania, and Harborview Medical Center in Seattle will participate in the 12-month trial.

“Patients remember precious little about what happens in the doctor’s office,” says Tom Delbanco, M.D., a primary care physician at BIDMC and the Richard and Florence Koplow-James Tullis Professor of General Medicine and Primary Care at Harvard Medical School. “We expect OpenNotes will improve patient recall, help patients take more responsibility for their care, and offer an opportunity for avoiding potential medical errors as patients and families monitor and think about their care in a much more active and knowledgeable way.”

That premise is based in part on a recent study by Delbanco and Jan Walker, R.N., M.B.A., instructor in medicine in the Division of General Medicine and Primary Care at BIDMC and Harvard Medical School. As reported in the Journal of General Internal Medicine, Delbanco and Walker found that most consumers want full access to their medical records.

The study also found that consumers expect computers to play a major role in their future medical care, even substituting for face-to-face doctor visits.

“We learned that, for the most part, patients are very comfortable with the idea of computers playing a central role in their care,” Walker says. In fact, patients said they not only want computers to bring them customized medical information, they fully expect that in the future they will be able to rely on electronic technology for many routine medical issues, she says.

“Doctors have strong differences of opinion about giving patients access to their notes. However, the debate is largely uninformed by evidence,” says Stephen Downs, assistant vice president at RWJF and member of the Foundation’s Pioneer Portfolio. “In the context of a physician’s day-to-day work, opening up notes is a subtle change—but it could reposition notes to be for the patient instead of about the patient, which might have a powerful impact on the doctor-patient relationship and, in the long run, lead to better care.”

To collect evidence, physicians and patients will fully share, through a simple one-step intervention, all encounter notes online. By contrasting the experience of trial participants with unenrolled physicians and patients, the researchers hope to measure the impact of OpenNotes through online surveys of both groups of doctors and patients.

“While this intervention potentially could disrupt the current flow of primary health care, it holds considerable potential to transform the doctor-patient relationship,” says Delbanco. “By enabling patients to read their clinicians’ notes, OpenNotes may break down an important wall that currently separates patients from those who care for them. It may promote insight and shared decision-making by bringing closer together the unique expertise of the clinician and the unique understanding of himself or herself that each patient possesses.” (via

This summer, a team of 100 primary care physicians across the country will embark on the “OpenNotes” initiative. OpenNotes will give 25,000 patients the chance to read doctors’ notes on their medical records via a secure Internet portal.

“I think patients will not be very surprised by what they see”
The OpenNotes pilot program is designed to determine if access to doctors’ notes will result in improved doctor-patient communication. For doctors, notes serve as a reminder of the unique characteristics of the patient, their medical history, and their care. For patients, doctors’ notes may help to clarify issues or explain care approaches. The hope is that inviting patients to review their notes could improve their understanding of their health, foster productive communication, stimulate shared decision making, and ultimately lead to better outcomes.

“I think this may be a real step in transforming the patient and provider relationship,” said Tom Delbanco, MD, Professor, Harvard Medical School and Physician (Former Chief) Division of General Medicine & Primary Care, Beth Israel Deaconess Medical Center in Boston.

Some fear that patient access to physicians’ notes could have negative consequences, such as confusing or worrying patients.

“I think patients will not be very surprised by what they see,” said Dr. Delbanco. “In many ways, the note is supposed to mirror what happened in the encounter. But patients will probably get insight into what’s worrying their doctor and what their doctor’s intentions are. They also may find things for which they want more explanation. We don’t know exactly what will happen. But we are excited to find out if OpenNotes can improve care from both the physician and the patient perspective,” said Dr. Delbanco.

The program will be evaluated primarily through web-based surveys. Researchers believe that if the pilot goes well, OpenNotes could become the standard in years to come.

The full report is available here:

Mirth Demonstrates Health Information Exchange

Mirth Corporation, the leader in commercial open source healthcare information technology, successfully powered the nation's first publically staged multi-organization demonstration of NHIN Direct standards and technologies. The demonstration included secure clinical information exchange between healthcare providers across three prominent California-based Health Information Exchanges. It took place on July 9th at Redwood MedNet's 4th Annual HIE Conference in Santa Rosa, CA, 50 miles north of San Francisco.

Organizations participating in the landmark demonstration included the pioneering Redwood MedNet Health Information Exchange, as well as the Western Health Information Network from Long Beach, CA, and Physicians Medical Group of Santa Cruz. Technology partners supporting the initiative -- in addition to Mirth Corporation -- included Harris Corporation, MedPlus, creator of Care360, and Microsoft, developer of HealthVault, a personal health technology platform.

"Microsoft has been participating in the NHIN Direct effort because we believe connecting providers with each other and their patients is critical to driving improvements in the quality of care delivery," said Sean Nolan, chief technology architect in Microsoft's Health Solutions Group. "We were delighted to support this landmark demonstration and show that healthcare interoperability can be a reality today, thanks to technologies like Mirth and HealthVault."

The Nationwide Health Information Network (NHIN) represents a set of federally architected standards for health information exchange, as well as "on ramp" tools to enable healthcare organizations to exchange health information more easily. NHIN Direct, a companion project sponsored by the department of Health and Human Services, seeks to enable simple, secure transport of health information between healthcare providers -- including summary care records, referrals, discharge summaries and other clinical records.

Redwood MedNet, which operates a health information exchange (HIE) service in Northern California based on the Mirth open source software, conceived and managed the NHIN Direct demonstration. "NHIN Direct as a project is designed to accelerate adoption of HIE services," said Will Ross, Project Manager for Redwood MedNet. "We produced the live demonstration of NHIN Direct at our conference in order to highlight how transformative health information exchange technology can be. Broad adoption and use of these tools is not a question of 'if' but rather is only a question of 'when' agile electronic exchange of patient data will become the dominant paradigm."

Mirth continues to focus its energy and innovation on making interoperability tools widely and inexpensively available to healthcare organizations and providers," said Jon Teichrow, president of Mirth Corporation. "This successful demonstration -- using production code on real use cases with real physician users -- shows that the Health Internet can be a reality today. The implications are profound: when healthcare providers and organizations can get on the same page around patient information, good things happen in terms of safety, quality and cost," added Teichrow.

The demonstration used fictitious patient records to avoid any disclosure to the 200+ attendees, but used real system and production code, as well as "hands on" participation by physicians who helped narrate the demonstration. It took advantage of the widely used Mirth technology as well as NHIN direct standards that enable provider-to-provider exchange of clinical records using a secure email-like approach, with SMTP as the message protocol. It showed how electronic records and messages can support the care of a patient who presents in a hospital emergency department hundreds of miles from home -- and be safely and rapidly treated by an emergency physician who can access his medication records, allergies, as well as his primary physician for consultation.

For more information about the demonstration, please visit:


Friday, July 16, 2010

Study Like a Scholar, Scholar

Student employees and Brigham Young University video staff created this Old-Spice-themed ad for Brigham Young University's Harold B. Lee Library. This is really quite funny and creative...

Tip of the hat to

PCAST Report on Health Information Technology

Watch this report on Health Information Technology to the President's Council of Advisors on Science and Technology (PCAST) during their July 16, 2010 meeting:

The report has been released. You can view the report and video at the PCAST Report on Health IT post.


Thursday, July 15, 2010

Defining moment for meaningful use

We have reached a fulcrum point in the history of health care in our country. The announcement on Tuesday of the final rule establishing Medicare and Medicaid incentive programs for the meaningful use of electronic health records (EHR) creates a framework for change that will have reverberations throughout the health care industry. An important companion rule (pdf) was also released that establishes standards, specifications and certification criteria for EHRs.

David Blumenthal, the national coordinator for health information technology at Health and Human Services (HHS), and Marilyn Tavenner, principal deputy administrator of the Centers for Medicare and Medicaid Services (CMS), published an overview of the meaningful use rule in the the New England Journal of Medicine. John D. Halamka, of both Harvard Medical School and Beth Israel Deaconess Medical Center, wrote an excellent analysis of the final standards rule on his blog. I expect in the coming months there will be a great deal of parsing of the language of these two rules, which total 1,092 pages.

For my initial analysis, see the post on O'Reilly Radar ~ Analysis: A defining moment for "meaningful use"

The rule has added the recording of advanced directives and a provision for providing patients with educational materials, which were not included in the proposed rule. However, the proposed rule's requirement to provide an electronic copy of a patient's medical record is maintained in the final rule. This record must contain diagnostic test results, problem list, medication list, medication allergies, and for hospitals, discharge summary and procedures for at least 50 percent of patients within three business days. This requirement may prove to be one of the most difficult to achieve, but as Regina Holliday's poignant testimony during the press conference proves (video below), it is vital to include consumers in the process.

Regina Holliday is a 37-year old mother of two and an art teacher. Last summer, her husband, Fred, died from kidney cancer at the age of 39. She writes at the Medical Advocacy Blog and tweets at @ReginaHolliday.

Tuesday, July 13, 2010

Meaningful Use Announcement

Health and Human Services Secretary Kathleen Sebelius announced final rules to help improve Americans' health, increase safety and reduce health care costs through expanded use of electronic health records (EHR).

- Kathleen Sebelius, Secretary, US Dept of Health & Human Services (HHS)
- Dr. Donald Berwick, Director, Center for Medicare & Medicare Services (CMS)
- Dr. David Blumenthal, Director, ONC for Health IT
- Dr Regina Benjamin, US Surgeon General
- Reginal Holliday, patient advocate

A Meaningful Definition

The Office of the National Coordinator for Health Information Technology (ONC) issued a final rule defining meaningful use requirements to qualify for incentive payments under the HITECH portion of the ARRA. The final rule for meaningful use is embedded below (it is temporarily available at the Public Inspection Desk, but this link will expire after the rule is actually published) and it is scheduled to be published in the Federal Register July, 28 2010. The rule definitively outlines all the specifics of Stage 1 meaningful use and clinical quality measure reporting to receive the incentive payments in 2011 and 2012. The final rule builds on the notice of proposed rulemaking (NPRM) released December 30, 2009.

The definition of meaningful use attempts to harmonize criteria across other CMS programs as much as possible and coordinate with quality initiatives. It also is closely linked to the certification standards criteria in development by the Office of the National Coordinator (ONC) and provides a platform for a staged implementation over time. The temporary certification final rule was published in the Federal Register June 24, 2010. The final rule on Initial Set of Standards, Implementation Specifications, and Certification Criteria is below the meaningful use rule.

Initial Set of Standards, Implementation Specifications, and Certification Criteria

Monday, July 12, 2010

CMS and ONC press briefing on Meaningful Use & Standards and Certification

CMS and ONC to Issue Final Rules on Meaningful Use and Standards and Certification for Electronic Health Records Incentive Program
U.S. Department of Health and Human Services:
CMS and ONC will host a press briefing to announce the final rules on Meaningful Use and Standards and Certification under the HITECH Act’s Electronic Health Records (EHR) incentive program.
Kathleen Sebelius, Secretary, U.S. Department of Health and Human Services
Donald Berwick, M.D, Administrator, Center for Medicare & Medicaid Services
David Blumenthal, M.D., M.P.P., National Coordinator for Health Information Technology
Regina Benjamin, M.D., M.B.A., Surgeon General
Tuesday, July 13, 2010
10:00 a.m. EDT
Great Hall, Hubert H. Humphrey Building
200 Independence Avenue, S.W.,
Washington, D.C. 20201
Dial In:
Call in: 800-857-6748
Verbal Passcode: HHS
To watch the webcast live visit


Requirements and Recommendations for the State Health Information Exchange Cooperative Agreement Program

The recent Program Information Notice for State Health Information Exchange Cooperative Agreement Programs might give some insight into the requirements for health information exchange under the soon to be released 'meaningful use' final rule:

Program Information Notice

Document Number: ONC-HIE-PIN-001

Date: July 6, 2010

Document Title:  Requirements and Recommendations for the State Health Information Exchange Cooperative Agreement Program
TO:  State Health Information Exchange Cooperative Agreement Program Award Recipients

As stated in the State Health Information Exchange Cooperative Agreement Program Funding Opportunity Announcement (FOA), the Office of the National Coordinator for Health Information Technology (ONC) may offer program guidance to provide assistance and direction to states and State Designated Entities (SDEs) that receive awards under the program.  The purpose of this Program Information Notice (PIN) is to clarify the FOA with respect to state and SDE responsibilities under the program, recommended roles for the State HIT Coordinators, and elements of the state strategic and operational plans. 
If you have any questions or require further assistance, please contact your project officer or the State Health Information Exchange Cooperative Agreement Program

David Blumenthal
National Coordinator



This PIN provides direction to state level efforts under the State Health Information Exchange Cooperative Agreement Program (State HIE Program).  Specifically, this PIN clarifies the State Health Information Exchange Cooperative Agreement Program Funding Opportunity Announcement, EP-HIT-09-001, CFDA 93.719, with respect to state/SDE1 responsibilities under the program, recommended roles for the HIT Coordinators, and elements of the state strategic and operational plans.  Success of this program is dependent on a strong and productive collaboration between states/SDEs and ONC.     
The HITECH Act authorized the award of funds to states/SDEs to facilitate and expand health information exchange (HIE) among organizations.  These resources, which should be viewed as a one-time investment, can provide a critical impetus to facilitate state HIE efforts including those meeting HIE meaningful use requirements, but substantial challenges face ONC and states/SDEs in developing the robust exchange infrastructure that we all seek.  The amount of funding and timeline will in many cases make it challenging for states to implement and operate comprehensive statewide health information exchange services.  States, therefore, should carefully consider the advantages and disadvantages of using limited HITECH funds -- without substantial other sources of support and/or a strong existing infrastructure -- to immediately deploy a robust, fully developed statewide exchange.  Similarly, the alternative of deploying a series of local pilots of exchange, while useful for the long-term, may not enable the levels of exchange necessary to meet the requirements for meaningful use, especially as these requirements become more demanding in later stages.  Furthermore, ONC is concerned that HIE sustainability models that rely on mandated provider or hospital participation in specific HIE services offered by the state or SDE might inappropriately limit provider choices in the full array of information exchange alternatives, thereby threatening the ability of providers to achieve meaningful use, particularly where state-designated services are still limited or nonfunctional. 

While states have the responsibility to determine HIE strategies that may be accomplished through a variety of approaches, ONC will work with states to be creative and resourceful, identifying ways touse these critical but scarce resources to fill gaps in a thoughtful and reality-based way while leveraging existing information exchange activities and engaging trading partners to encourage and sustain health information sharing.  We encourage states to focus on targeted actions to ensure that all eligible providers have options to meet meaningful use information exchange requirements.
A common set of principles shapes ONC’s work in health information exchange including the state HIE program:
  • Support privacy and security
  • Focus on desired outcomes, especially meaningful use of EHRs 
  • Support HIE services and adoption for all relevant stakeholder organizations, including providers in small practices, across a broad range of uses and scenarios
  • Be operationally feasible and achievable, building on what is already working
  • Remain vigilant and adapt to emerging trends and developments
  • Foster innovation

Please note that the terms “shall” and “should” are used in very specific ways in this document.  “Shall” equals a mandatory action while “should” equals a recommended course of action within the State HIE Program.

Key Deliverables and Objectives for State HIE in 2011

The immediate priority of the State HIE Program is to ensure that all eligible providers within every state have at least one option available to them to meet the HIE requirements of meaningful use in 2011.  The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that sets forth proposed Stage 1 criteria for meaningful use to include objectives and associated measures for the exchange of health information.  75 Fed. Reg. 1844 (Jan. 13, 2010).  References to meaningful use requirements in this PIN are based on the proposed rule.  In the event that the proposed rule is finalized and/or additional rules or guidance are issued related to meaningful use, ONC may update this PIN or issue further guidance as appropriate.  Therefore, in support of this program priority related to meaningful use in 2011, states and SDEs shall outline in their State Strategic and Operational Plans (state plans) a concrete and operationally feasible plan to address and enable these three HIE capabilities in the next year2:

  1. E-prescribing
  2. Receipt of structured lab results
  3. Sharing patient care summaries across unaffiliated organizations

State and SDE Responsibilities under the State HIE Program in 2011
States and SDEs are given discretion to determine how best to enable these HIE capabilities in their health care delivery and market environments and how to ensure that options will be available to satisfy the increasingly robust exchange requirements for meaningful use.  However, consistent with the description of program requirements in the FOA, states and SDEs shall fulfill the following six responsibilities for continued funding as part of their participation in the State HIE Program.  Specifically, states and SDEs shall use their authority, programs, and resources to:
  1. Initiate a transparent multi-stakeholder processConvene a representative group of relevant stakeholders, including consumers, to set clear goals for state HIE efforts and assess how those efforts can link to and support care delivery and payment reforms.  Additionally, states and SDEs shall analyze and fully understand the health information exchange currently taking place within the state, complete a gap analysis, and determine how the state or SDE needs to address these gaps to ensure options are available to eligible providers in the state who seek to meet the Stage 1 meaningful use requirements for HIE, with a focus on delivery of structured lab results, e-prescribing, and sharing patient care summaries across unaffiliated organizations. 

  1. Monitor and track meaningful use HIE capabilities in the state-Set the baseline, monitor, and report on the following measures as required by the State HIE Program, which will be finalized in additional program guidance:
    • % health plans supporting electronic eligibility and claims transactions
    • % pharmacies accepting electronic prescribing and refill requests
    • % clinical laboratories sending results electronically
    • % health departments electronically receiving immunizations, syndromic surveillance, and notifiable laboratory results

  1. Assure trust of information sharingEnsure the state has a privacy and security framework for state health information exchange efforts that is consistent with and clearly addresses the elements of the HHS HIT Privacy and Security Framework found at

  1. Set Strategy to Meet Gaps in HIE Capabilities for Meaningful Use—Develop and implement a strategy and work plan to address the gaps in HIE capabilities as identified in the environmental scan with a focus on delivery of structured lab results, e-prescribing and sharing patient care summaries across unaffiliated organizations.
Gap-filling strategies might include:
·         Policy, purchasing and regulatory actions, such as requiring e-prescribing or electronic sharing of lab results in state or Medicaid contracts with pharmacies and clinical labs.
·         Core services to reduce the cost and complexity of exchange including authoritative provider and plan directories and authentication services that would support both simplified and comprehensive interoperability.
·         Targeted infrastructure for gap areas such as shared services for small labs or pharmacies, or to serve rural providers, which could utilize both simplified and comprehensive interoperability solutions.
In filling these gaps, the state is not required to directly provide or construct technology infrastructure or services. A key role for states can be to provide leadership and direction to public and private stakeholders.  States may also use policy and purchasing levers to extend and enhance existing HIE activities in the state so as to encourage key trading partners such as pharmacies and clinical laboratories to participate in electronic service delivery and to enable providers to meet meaningful use requirements.  

States shall also establish a strategy and immediate next steps to address the following over the course of the project:
·         Building capacity of public health systems to accept electronic reporting of immunizations, notifiable diseases and syndromic surveillance reporting from providers.
·         Enabling clinical quality reporting to Medicaid and Medicare.

  1. Ensure consistency with national policies and standards—States and SDEs shall ensure that any HIE services that are funded through this program are consistent with national standards, NHIN specifications, federal policies and guidelines, and are based on technologies that are adaptable and flexible for future requirements, including exchange of information across state boundaries.

  1. Align with Medicaid and public health programs—States and SDEs shall coordinate with Medicaid and public health programs to establish an integrated approach including having both programs represented in the state’s governance structure and processes.

Federal Government Participation
As stated in the FOA, the ONC will work with states to advance interoperability and health information exchange through a variety of activities, including:
·         Collaborate with states and SDEs to promote, monitor and share efficient, scalable and sustainable mechanisms for HIE within and across states.
·         Help to coordinate and share information regarding federal health IT investments and programs across agencies (e.g., CDC, CMS, HRSA, AHRQ, ONC and non-HHS federal agencies).
·         Conduct a national program evaluation and offer technical assistance for state-level evaluations.
·         Adopt standards and certification criteria to enable interoperability and HIE.
·         Provide technical assistance to states and SDEs.
·         Coordinate information sharing across states.
·         Advance standards-based HIE through Nationwide Health Information Network (NHIN) standards, services and policies.

Recommended Roles for HIT Coordinator
ONC requires each state to have an HIT Coordinator who will provide HIT leadership and coordination across the federally funded state programs including supporting the efforts of the State Medicaid Directors (SMDs) in developing the state’s Medicaid EHR incentive program.  We expect the Coordinator to fulfill two main roles while realizing that states have flexibility in how these roles are fulfilled:
·         The HIT Coordinator should develop and advocate for HIT policy to achieve statewide goals.  The Coordinator will need to focus and prioritize activities to make rapid progress to help state providers meet stage 1 meaningful use requirements.  Key activities may include:
o   Collaborate with state health policy makers in establishing HIT strategies for reaching shared health care goals.
o   Leverage state purchasing power such as establishing requirements for entities reimbursed by the state to participate in e-prescribing, electronic labs results delivery or electronically sharing care summaries across transitions in care.  
o   Address legal or policy issues to ensure the information may be shared securely and with appropriate privacy protections.
o   Lead efforts to enable interstate HIE, such as harmonizing privacy policies and consent laws with neighboring states where appropriate.
·         The HIT Coordinator should coordinate HIT efforts with Medicaid, public health and other federally funded state programs. Examples of the Coordinator fulfilling this role include:
o   Advance operationally viable strategies that accelerate the success of the EHR incentive program in meeting shared meaningful use goals.
o   Ensure state program participation in planning and implementation activities including, but not limited to Medicaid, behavioral health, public health, departments of aging.
o   Ensure that State Medicaid HIT Plans and State HIE plans are coordinated. 
o   Leverage various state program resources such as immunizations registries, public health surveillance systems, and CMS/Medicaid funding to ensure resources are being maximized (e.g., ARRA authorized Medicaid 90/10 match leverage to support HIE activities).
o   Assure integration of other relevant state programs into the state’s HIT governance structure.
o   Identify, track and convene the various federal HIT grantees for cross-program coordination and to leverage program resources.  Examples: RECs, Beacon Communities, Community Colleges involved in HIT workforce efforts, HRSA HIT adoption projects, federally supported broadband programs, CHIPRA HIT grantees.
Based on the above program guidance including state/SDE responsibilities and HIT Coordinator roles, and also based on issues that have arisen in the first wave of state plans that have been submitted to ONC, the following attachment contains additional guidance on developing state strategic and operational plans for a successful program.  Additional resources to assist in the development of state plans, including a new chart showing requirements of the FOA and this PIN, can be found at

End Notes
1 References to states and SDEs throughout this PIN are used interchangeably unless inconsistent with the context or otherwise indicated.
Administrative transactions with health plans and Medicaid, and public health reporting will be the subject of future operational plans.

Guidance on State Strategic and Operational Plans (State Plans)
In an effort to support the success of states and SDEs participating in the State Health Information Exchange Cooperative Agreement Program, ONC has compiled this planning guidance to highlight and clarify an important subset of plan requirements. Detailed guidance on state plans, including a chart with requirements for plan content, can be found at

Environmental Scan
Within the strategic plan, the environmental scan shall include an overview of the current HIE activities within the state including the penetration of electronic lab delivery, e-prescribing networks and other existing HIE solutions.   The environmental scan should include the following measures or similar measures to determine the health information exchange taking place with these important data trading partners:
  • % pharmacies accepting electronic prescribing and refill requests
  • % clinical laboratories sending results electronically
  • % health plans supporting electronic eligibility and claims transactions
  • % health departments receiving immunizations, syndromic surveillance, and notifiable laboratory results

Strategy to Meet Meaningful Use
Strategic plans shall describe the state’s overall strategy for supporting Stage 1 meaningful use including how to fill gaps identified in the environmental scan.  Specifically, states and SDEs shall describe how they will invest federal dollars and associated matching funds to enable eligible providers to have at least one option for each of these Stage 1 meaningful use requirements in 2011:
  1. E-prescribing
  2. Receipt of structured lab results
  3. Sharing patient care summaries across unaffiliated organizations

As part of the Strategic Plans, states and SDEs should also describe a strategy and plan to address the other required information sharing capabilities specified in the FOA over the course of the project, including, but not limited to:
·         Building capacity of public health systems to accept electronic reporting of immunizations, notifiable diseases and syndromic surveillance reporting from providers;
·         Enabling electronic meaningful use and clinical quality reporting to Medicaid and Medicare.

Coordination with Medicaid
Because of the importance of the Medicaid program in setting state level HIT policy, states and SDEs are required to describe their coordination with Medicaid in their Strategic Plans.   The following activities are either required or highly encouraged and the activities adopted shall be reflected in the state HIE plan.
Required Activities:
1.           The state’s governance structure shall provide representation of the state Medicaid program.
2.           The grantee shall coordinate provider outreach and communications with the state Medicaid program.
3.           The grantee and the state Medicaid program shall identify common business or health care outcome priorities.
4.           The grantee, in collaboration with the Medicaid program, shall leverage, participate in and support all Beacon Communities, Regional Extension Centers and ONC funded workforce projects in its jurisdiction.
5.           The grantee shall align efforts with the state Medicaid agency to meet Medicaid requirements for meaningful use.

Encouraged Activities:
6.           The state‘s HIE program is encouraged to obtain a letter of support from the Medicaid Director.  If a letter of support is not provided, ONC will inquire as to why one was not provided and the lack of a letter may impact the approval of a state plan, depending on circumstances.
7.           Conduct joint needs assessments.
8.           Conduct joint environmental scans.
9.           Collaborate with the Medicaid program and the ONC-supported Regional Extension Centers to provide technical assistance to providers outside of the federal grant for Regional Extension Centers’ scopes of work.
10.       Leverage public help desk/call center contracts and services between the State HIE Program, Medicaid and the REC.
11.       Conduct joint assessment and alignment of privacy policies at the statewide level and in the Medicaid program.
12.       Leverage existing Medicaid IT infrastructure when developing the health information exchange technical architecture.
13.       Determine whether to integrate systems to accomplish objectives such as making Medicaid claims and encounters available to the health information exchange and information from non-Medicaid providers available to the Medicaid program.
14.       Determine which specific shared services and technical services will be offered or used by Medicaid.
15.       Determine which operational responsibilities the Medicaid program will have, if any.
16.       Use Medicaid HIT incentives to encourage provider participation in the health information exchange.
17.       Collaborate during the creation of payment incentives, including Pay for Performance under Medicaid, to encourage participation by additional provider types (e.g. pharmacies, providers ineligible for incentives).

HIE Sustainability Plans
ONC recognizes the importance and challenges of developing a sustainable health information exchange capability.  It is essential, therefore, that for the initial submittal of the Strategic Plan, that states and SDEs shall describe initial thoughts for sustaining HIE activities during and after the cooperative agreement period. It is important to consider how to achieve sustainability based on the model being pursued and to incorporate any work that has been done to test the market acceptance of revenue models. The primary focus of sustainability should be on sustaining information sharing efforts, and not necessarily the persistence of government-sponsored health information exchange entities.  ONC anticipates that annual updates to the state plans will provide further developed approaches and activities for long-term HIE sustainability.

Facilitating Services - If the state HIE effort is facilitating the statewide coverage of HIE services using a variety of exchange methods, the state plan shall describe preliminary plans for how sustainability of the HIE market in the state may be enhanced by state or SDE actions including any state policy or regulation. Specific plans for sustainability of any directories or authentication services offered at the state level by the grantee must be addressed during the course of the four-year program.

Directly Offering Services - If the state HIE effort is directly providing the services, the state plans shall provide preliminary but realistic ideas on who will pay for the services and under what mechanisms (e.g., per transaction fees, subscription models, payers receiving a percentage allocation based on their covered base)  The state plan should also consider how program sustainability can be supported by state policy or regulation including payment reforms to incentivize demand for information sharing or contracting requirements to ensure participation of key partners such as labs and pharmacies.  

Executing Strategy for Supporting Meaningful Use
Operational plans shall describe how the state will execute the state’s overall strategy for supporting Stage 1 meaningful use including how to fill gaps identified in the environmental scan.  Specifically, states and SDEs shall describe how they will invest federal dollars and associated matching funds to enable eligible providers to have at least one option for each of these Stage 1 meaningful use requirements in 2011:
  1. E-prescribing
  2. Receipt of structured lab results
  3. Sharing patient care summaries across unaffiliated organizations

For each of these areas, the Operational Plans shall:
·         Outline a clear and viable strategy to ensure that all eligible providers in the state have at least one viable option in 2011;
·         Include a project timeline that clearly illustrates when tasks and milestones will be completed;
·         Provide an estimate of all the funding required, including all federal funding and state funding,  used to enable stage one meaningful use requirements;
·         Indicate the role both in funding and coordination of the state Medicaid agency in achieving the state strategy;
·         Identify potential barriers and risks including approaches to mitigate them; and,
·         Identify desired technical support and coordination from ONC to support the state strategy.

Project Management Plans
State Operational Plans shall include a robust project management plan with specific timelines, milestones, resources and interdependencies for all the activities in the state’s HIE project.  States and SDEs shall explain their project management approach including the project plan tasks that are managed by vendors in order for ONC to judge the comprehensiveness and the feasibility of the plans. State plans should also describe the change management and issue escalation processes that will be used to keep projects on schedule and within budget.

Risk Assessment
Managing risk is an important element of successfully building HIE capacity to support meaningful use. Within their Operational Plans, States and SDEs shall identify known and potential risks and describe their risk mitigation strategies. Risks should be prioritized using risk severity and probability. Examples of risks that may be included are: changes in the HIE marketplace, evolving EHR and HIE standards, lack of participation of large stakeholders including Medicaid, breach of personal health information.
HIE Architecture and Standards
Within the operational plans, States and SDEs shall describe the technical approach taken to facilitate data exchange services within the state based on the model being pursued. 

Facilitating Services - If the state HIE effort is facilitating the statewide coverage of HIE services using a variety of exchange methods, the state plans shall describe the approach of obtaining statewide coverage of HIE services to meet meaningful use requirements and also the processes or mechanisms by which the state or SDE will ensure that the HIE services comply with national standards.   

Directly Offering Services - If the state HIE effort is directly providing or provisioning services (including shared directories or provider authentication services) the state plans shall provide either the detailed specifications or describe the process by which the detailed specifications will be developed.  For those plans that don't have a detailed architecture, the updated Notice of Award for implementation will have a requirement to provide the detailed plans at a later date. 

When developing strategies for their state plans, states may be eligible to participate in the development, testing and implementation of various standards and services including those offered by the NHIN:
    • Authoritative directories that are web-enabled and support standards-based queries, including:
      • Health care provider directories
      • Health plan directories
      • Directories of licensed clinical laboratories
    • Identity Assurance and Authentication Services: These services should meet relevant state and federal privacy and security requirements and be appropriate to the exchange approach selected. They should include: 1) ability to ensure the provider receiving the record is authorized and is who they claim to be and, 2) ensure the provider sending the information is an authorized recipient of the information.
    • Secure Routing
    • NHIN Direct specifications to enable simplified interoperability between two known endpoints
    • NHIN Exchange services for robust information exchange, such as:
      • Master Patient Index
      • Patient locator services
      • Document lookup and retrieval

The use of standards to support HIE enabling technology is a critical aspect of this program and needs to be part of a longer-term framework to support interoperability.  Due to the evolving nature of health information technology, standards, requirements related to meaningful use, and standards adoption, there should be an explicit mechanism specified in state plans that ensures adoption and use of standards adopted or approved by the Department of Health and Human Services (HHS) as well as the appropriate engagement with ONC in the ongoing development and use of the NHIN specifications and national standards to support meaningful use.  The plans should also explain how the states will encourage any vendors or service providers to follow national standards, address system modularity, data portability, re-use of interfaces, and vendor transition provisions. 

Privacy and Security
Within the Operational Plans, States and SDEs shall develop and fully describe their privacy and security framework including the specific policies, accountability strategies, architectures and technology choices to protect information. The state privacy and security framework shall be consistent with applicable federal law and policies. To assist the states, ONC will provide guidance on security and privacy policies and programs in the near future.  The state plan shall contain a description of the analysis of relevant federal and state laws as related to HIE and the plans for addressing any issues that have been identified.  If an analysis hasn’t been done, the state or the SDE shall provide a description of the process and the timeline for completion.  Furthermore, states should describe the methodsused to ensure privacy and security programs are accomplished in a transparent fashion.   If a complete framework is not available, the state or the SDE shall describe the process they will use to fully develop such a framework. The framework must address all the principles outlined in the HHS HIT Privacy and Security Framework, including:

- Disclosure Limitation
- Individual Access
- Correction
- Openness and Transparency
- Individual Choice
- Collection and Use
- Data Quality and Integrity
- Safeguards
- Accountability