Monday, November 23, 2009

Harvard School of Public Health: Leadership Strategies for Information Technology in Health Care: A Certificate Program

It is my distinct honor and privilege to be involved in directing a module for this course at HSPH. We have been very fortunate in assembling a stellar lineup of faculty drawn from several Harvard Schools (Medicine, Public Health, Business) as well as from leading institutions across the country. All are excellent teachers, steeped in the theory and practice of health care delivery and transformation. Attendees will have extraordinary access to faculty in a setting conducive to learning and interaction in all four modules.

Program Dates:

January 25–29, 2010
Module I: IT Strategy and Governance (John Glaser, Director)
Module II: Electronic Health Records (EHR) (John Halamka, Director)

May 17–21, 2010
Module III: Maximizing Quality and Safety Gains from EHRs (Ashish Jha, Director)
Module IV: Continuous Improvement with Health Care IT (Blackford Middleton, Director)
 
Additional information from the Program Overview and additional information on the HSPH website:

Increased competition, coupled with higher levels of commoditization, is driving the need to remain competitive in the ever-changing health care marketplace. This certificate program is comprised of four modules that will provide the knowledge necessary to design and develop a cogent Information Technology (IT) strategy.

The Obama administration has declared IT as one of the main objectives for transforming health care. Along with government policy initiatives, the economic landscape is driving an immediate need for health care organizations to improve efficiencies and reduce costs, while maintaining a sharp focus on patient quality and satisfaction.

The ability to design, develop, and deliver IT projects, strategy, and initiatives using proven tools and techniques is paramount to having a positive impact on the organization's mission and, ultimately, margin.

The modules in this series are designed specifically for senior level professionals and executives, with technology responsibilities from various avenues of the health care industry, seeking to build IT knowledge.

Thursday, October 22, 2009

Interview on ehrTV

Recently, I had the pleasure of talking with Dr. Eric Fishman of ehrTV about all things EMR, PHR, clinical decision support, and evidence-based medicine. It's not Hollywood, but was fun to do. Eric is very knowledgeable himself about the business, and ehrTV has some impressive goals and plans to help with general education in the whole healthcare information technology space. Eric was an adept interviewer, and I encourage others who might want to help with this educational activity to talk with him, too. See http://ad.vu/mpaa for interview, and www.ehrscope.com.

Monday, October 5, 2009

MIE2009: Medical Informatics Europe

I had the great pleasure of visiting Sarajevo, Bosnia-Herzogovina in early September to attend MIE2009: Medical Informatics in a United and Health Europe. It was a terrific conference, put on by Prof Klaus-Peter Adlassnig, Chair of the Scientific Programme Committee, Prof Izet Masic, Chair of the Local Organizing Committee, and Jacob Hofdijk, PhD, President of the European Federation for Medical Informatics. My kenote address on clinical decision support is available at the link above.

More importantly, however, there is a LOT going on in Europe with clinical informatics. See the many fantastic presentations available at http://www.hst.aau.dk/~ska/MIE2009/ProgramEventsMIE2009.htm.

Take a peek to get a quick update on what's going on in Europe! Enjoy. 

Reading Google Bundles

Thinking about how to keep up with the Tsunami of reading that I attempt to do I came across "Google Bundles". I use Google Reader as my method to organize news feeds from all sorts of places. This service has the added utility that it is easily integrated with iPhone news readers (Newstand my favorite), as well as Blackberry news readers (e.g. Viigo, my BB favorite) (or aggregators of RSS feeds) because you can simply refer to the Google Reader as source. Anyway, i've posted at the bottom of my blog here the news feeds I look at almost daily.

Please suggest others that you think are interesting and relevant to clinical informatics, healthcare, policy, and technology. Enjoy!

Thursday, May 14, 2009

Revisiting the eHealth Code of Ethics

Recently, we held the Harvard CME Course on Patient-centered Care and eHealth: Transforming Health Care Quality. It was a lot of fun (if you will allow the biased point of view!, I was course Director), and attendees from all across the US and 4 continents seemed to have a good time. We’ll see what the final evaluations say!

One feature of the course is a provider-patient panel on the last day in which any and all topics pertaining to the use of eHealth technologies by actual patients and their providers is discussed. Two providers from the Partners Healthcare System (both MGH docs as it turns out), and two of their patients shared the stage for a bit to each offer their perspectives on doctor-patient email, use of the PHR, and what does it all mean in terms of the e-enabled doctor-patient relationship, and more.

I tweeted on this briefly, and got a few interesting cross-tweets a small sample of which are below:

# healthythinker RT @bfm #harvardehealth Can virtual visits support MD-Patient relationship? Yes... but requires pre-existing relationship with trust

#harvardehealth Pts: need to be told new info in person can be harmful to receive new info impersonally, w/o context or interpretation

#harvardehealth #PHR Pt: maybe better for direct MD to MD sharing so Pt doesn't have to filter, translate, communicate, etc....

#harvardehealth Pt: we're already responsible for moving info around.. but I may not understand what info you (MD) deem important to tell

#harvardehealth #PHR Pt: maybe control isn't the right word bc it implies censoring... rather be complete and trusting = full disclosure

#harvardehealth How do we assess veracity/accuracy of #PHR data?

#harvardehealth Provider: we need a 'private space' for clinicians to speculate about things, reflect uncertainty...

#harvardehealth Provider: can't say "Funny Looking Kid" in the #EMR anymore... but how do we reflect clinical uncertainty

#harvardehealth Patient: i don't want the insurance company all over my record, or the FDA... #PHR data is discoverable

#harvardehealth Pt: if I trust my MD I am happy to share all info... give full access to my #PHR data, unfiltered.

#harvardehealth Patient: is MD legal liability less when patient doesn't share all relevant info with provider? #PHR #EMR


#harvardehealth Providers on panel says #EMR data need to be kept intact 'as is' when shared with #PHR

#harvardehealth patient access in #PHR to #EHR data means Docs cannot document the way they used to!

#bfm #harvardehealth Should pt be able to NOT share certain info from MD? Patient says YES! e.g. old info not relevant?

#harvardehealth Need to be aware of spectrum of options from 'self-service' pt care, to fully supported pt in when sick.

#harvardehealth The patient's responsibility to share pt-controlled info is dependent on patient status, healthcare state.

#harvardehealth Patient panel with two patients: is there too much information to share? NO!, but.. it depends on patient

# Dirk2_normal dirkstanley RT @john_chilmark: #harvardehealth Still big Q on terms of engagement processe... Read More: http://is.gd/vY9F

# Cycle1pot_normal john_chilmark Where #health20con was all SW Dev a few pts etc. #harvardehealth is all clinicians, would be great to do mash-up of the 2

#harvardehealth http://tr.im/iyOz Dr Michael Klompass - Paradox: the care of populations requires knowledge of individuals! (Data from #EMR)

#bfm #harvardehealth course http://tr.im/iyOz Paul Tang says build PHR and they will come. Wants-fears+loves=critical success factors for PHRs

Re-reading these thoughts made me think of the eHealth Code of Ethics which was produced by a summit of folks interested in eHealth in the very early days, including Ahmad Rizk, and Helga Rippen who have written this up in JMIR http://www.jmir.org/2000/2/e9/.

The core features of the eHealth Code of Ethics seem relevant to this day, and to the discussion we had at our course:


eHealth Code of Ethics Guiding Principles



1. Disclose information that if known by consumers would likely affect consumers' understanding or use of the site or purchase or use of a product or service.

Candor

People who use the Internet for health-related purposes need to be able to judge for themselves that the sites they visit and services they use are credible and trustworthy. Sites should clearly indicate

* who owns or has a significant financial interest in the site or service
* what the purpose of the site or service is
For example, whether it is solely educational, sells health products or services, or offers personal medical care or advice
* any relationship (financial, professional, personal, or other) that a reasonable person would believe would likely influence his or her perception of the information, products, or services offered by the site
For example, if the site has commercial sponsors or partners, who those sponsors/partners are and whether they provide content for the site


2. Be truthful and not deceptive

Honesty

People who seek health information on the Internet need to know that products or services are described truthfully and that information they receive is not presented in a misleading way. Sites should be forthright

* in all content used to promote the sale of health products or services
* in any claims about the efficacy, performance, or benefits of products or services

They should clearly distinguish content intended to promote or sell a product, service, or organisation from educational or scientific content.

3. Provide health information that is accurate, easy to understand, and up to date.

Quality

To make wise decisions about their health care, people need and have the right to expect that sites will provide accurate, well-supported information and products and services of high quality.
To assure that the health information they provide is accurate, e-Health sites and services should make good faith efforts to

* evaluate information rigorously and fairly, including information used to describe products or services
* provide information that is consistent with the best available evidence
* assure that when personalized medical care or advice is provided that care or advice is given by a qualified practitioner
* indicate clearly whether information is based on scientific studies, expert consensus, or professional or personal experience or opinion
* acknowledge that some issues are controversial and when that is the case make good faith efforts to present all reasonable sides in a fair and balanced way


For example, advise users that there are alternative treatments for a particular health condition, such as surgery or radiation for prostate cancer

Information and services must be easy for consumers to understand and use. Sites should present information and describe products or services

* in language that is clear, easy to read, and appropriate for intended users
For example, in culturally appropriate ways in the primary language (or languages) of the site's expected audience
* in a way that accommodates special needs users may have
For example, in large type or through audio channels for users whose vision is impaired


Sites that provide information primarily for educational or scientific purposes should guarantee the independence of their editorial policy and practices by assuring that only the site's content editors determine editorial content and have the authority to reject advertising that they believe is inappropriate.

Consumers have a right to expect that the information they receive is up to date. Sites should clearly indicate

* when the site published the information it provides (and what version of the information users are seeing if it has been revised since it was first published)
* when the site most recently reviewed the information
* whether the site has made substantive changes in the information and if so, when the information was most recently updated

and

Provide the information users need to make their own judgments about the health information, products, or services provided by the site. Individuals need to be able to judge for themselves the quality of the health information they find on the Internet. Sites should describe clearly and accurately how content is developed for the site by telling users

* what sources the site or content provider has used, with references or links to those sources
* how the site evaluates content and what criteria are used to evaluate content, including on what basis the site decides to provide specific links to other sites or services

For example, by describing the site's editorial board and policies


When health products or services are subject to government regulation, sites should tell users whether those products (such as drugs or medical devices) have been approved by appropriate regulatory agencies, such as the U.S. Food and Drug Administration or U.K. Medicines Control Agency

4. Respect users' right to determine whether or how their personal data may be collected, used, or shared.

Informed Consent

People who use the Internet for health-related reasons have the right to be informed that personal data may be gathered, and to choose whether they will allow their personal data to be collected and whether they will allow it to be used or shared. And they have a right to be able to choose, consent, and control when and how they actively engage in a commercial relationship.

Sites should clearly disclose

* that there are potential risks to users' privacy on the Internet
For example, that other organisations or individuals may be able to collect personal data when someone visits a site, without that site's knowledge; or that some jurisdictions (such as the European Union) protect privacy more stringently than others

Sites should not collect, use, or share personal data without the user's specific affirmative consent. To assure that users understand and make informed decisions about providing personal data, sites should indicate clearly and accurately

* what data is being collected when users visit the site
For example, data about which parts of the site the user visited, or the user's name and email address, or specific data about the user's health or online purchases
* who is collecting that data
For example, the site itself, or a third party
* how the site will use that data
For example, to help the site provide better services to users, as part of a scientific study, or to provide personalised medical care or advice
* whether the site knowingly shares data with other organisations or individuals and if so, what data it shares
* which organisations or individuals the site shares data with and how it expects its affiliates to use that data

For example, whether the site will share users' personal data with other organisations or individuals and for what purposes, and note when personal data will be shared with organizations or individuals in other countries
* obtain users affirmative consent to collect, use, or share personal data in the ways described
For example, to collect and use the visitor's personal data in scientific research, or for commercial reasons such as sending information about new products or services to the user, or to share his or her personal data with other organisations or individuals
* what consequences there may be when a visitor refuses to give personal data

For example, that the site may not be able to tailor the information it provides to the visitor's particular needs, or that the visitor may not have access to all areas of the site


"E-commerce" sites have an obligation to make clear to users when they are about to engage in a commercial transaction and to obtain users' specific affirmative consent to participate in that commercial transaction.

5. Respect the obligation to protect users' privacy.

Privacy

People who use the Internet for health-related reasons have the right to expect that personal data they provide will be kept confidential. Personal health data in particular may be very sensitive, and the consequences of inappropriate disclosure can be grave. To protect users, sites that collect personal data should

* take reasonable steps to prevent unauthorised access to or use of personal data
For example, by "encrypting" data, protecting files with passwords, or using appropriate security software for all transactions involving users' personal medical or financial data
* make it easy for users to review personal data they have given and to update it or correct it when appropriate
* adopt reasonable mechanisms to trace how personal data is used
For example, by using "audit trails" that show who viewed the data and when
* tell how the site stores users' personal data and for how long it stores that data
* assure that when personal data is "de-identified" (that is, when the user's name, email address, or other data that might identify him or her has been removed from the file) it cannot be linked back to the user


6. Respect fundamental ethical obligations to patients and clients.

Professionalism in Online Health Care

Physicians, nurses, pharmacists, therapists, and all other health care professionals who provide specific, personal medical care or advice online should

* abide by the ethical codes that govern their professions as practitioners in face-to-face relationships
* do no harm
* put patients' and clients' interests first
* protect patients' confidentiality
* clearly disclose any sponsorships, financial incentives, or other information that would likely affect the patient's or client's perception of professional's role or the services offered
* clearly disclose what fees, if any, will be charged for the online consultation and how payment for services is to be made
* obey the laws and regulations of relevant jurisdiction(s), including applicable laws governing professional licensing and prescribing

and

Inform and educate patients and clients about the limitations of online health care. The Internet can be a powerful tool for helping to meet patients' health care needs, but users need to understand that it also has limitations. Health care professionals who practice on the Internet should clearly and accurately

* identify themselves and tell patients or clients where they practice and what their professional credentials are
* describe the terms and conditions of the particular online interaction
For example, whether the health care professional will provide general advice about a particular health condition or will make specific recommendations and or referrals for the patient or client, or whether the health care professional can and will or cannot and will not prescribe medications in the particular situation
* make good faith efforts to understand the patient's or client's particular circumstances and to help him or her identify health care resources that are available locally
For example, to help the patient or client determine whether particular treatment is available in his or her home community or only from providers outside his or her community
* give clear instructions for follow-up care when appropriate or necessary


Health care professionals who offer personal medical services or advice online should

* clearly and accurately describe the constraints of online diagnosis and treatment recommendations
For example, providers should stress that because the online health care professional cannot examine the patient, it is important for patients to describe their health care needs as clearly they can
* help "e-patients" understand when online consultation can and when it cannot and should not take the place of a face-to-face interaction with a health care provider


7. Ensure that organisations and sites with which they affiliate are trustworthy.

Responsible Partnering

People need to be confident that organisations and individuals who operate on the Internet undertake to partner only with trustworthy individuals or organisations. Whether they are for-profit or nonprofit, sites should

* make reasonable efforts to ensure that sponsors, partners, or other affiliates abide by applicable law and uphold the same ethical standards as the sites themselves
* insist that current or prospective sponsors not influence the way search results are displayed for specific information on key words or topics


And they should indicate clearly to users

* whether links to other sites are provided for information only or are endorsements of those other sites
* when they are leaving the site
For example, by use of transition screens


8. Provide meaningful opportunity for users to give feedback to the site.

Accountability

People need to be confident that organisations and individuals that provide health information, products, or services on the Internet take users' concerns seriously and that sites make good faith efforts to ensure that their practices are ethically sound. e-Health sites should

* indicate clearly to users how they can contact the owner of the site or service and/or the party responsible for managing the site or service
For example, how to contact specific manager(s) or customer service representatives with authority to address problems
* provide easy-to-use tools for visitors to give feedback about the site and the quality of its information, products, or services
* review complaints from users promptly and respond in a timely and appropriate manner


Sites should encourage users to notify the site's manager(s) or customer service representatives if they believe that a site's commercial or noncommercial partners or affiliates, including sites to which links are provided, may violate law or ethical principles.

and

Monitor their compliance with the e-Health Code of Ethics. e-Health sites should describe their policies for self-monitoring clearly for users, and should encourage creative problem solving among site staff and affiliates.


###
I'm sure we'll be coming back to this a few more times over the years to come. Maybe next year at the Harvard eHealth CME Course.

The Clinical Decision Support Consortium

Background

Electronic health records (EHRs), when used effectively, can improve the safety and quality of medical care. For maximum benefit, however, EHRs must be paired with clinical decision support (CDS) systems to effectively influence physician behavior. CDS includes a variety of techniques designed to facilitate and guide doctors’ decision making toward evidence-based practice. Common examples of CDS include computerized checks for drug interactions and electronic reminders for screening tests like mammograms and Pap smears.

While the evidence that CDS can be effective is clear, current use and adoption of CDS is limited. In fact, most of what we know about CDS comes from only four academic medical centers and integrated delivery networks. Wider adoption of decision support has been held back by a variety of issues, including:

• Difficulty translating medical knowledge and guidelines into a form that can be used by EHRs.
• Technical challenges in developing a standard representation for CDS content that could be shared across sites.
• Absence of a central knowledge repository where human readable and executable guideline knowledge can be shared and stored.
• Challenges in integrating decision support into the clinical workflow and other barriers to IT adoption
• Limited capabilities for clinical decision support in commercially available electronic health record (EHR) systems.

The AHRQ Clinical Decision Support Consortium

While these issues have been barriers for adoption of clinical decision support systems they are surmountable, as evidenced by a small number of sites where decision support is pervasive. We believe that the biggest challenge to fostering widespread adoption of clinical decision support is in documenting, generalizing, and finally translating the experience from these advanced sites to a broader community of care sites. To address this challenge, investigators from Brigham and Women's Hospital, Harvard Medical School, and Partners HealthCare (PHS), have formed the AHRQ Clinical Decision Support Consortium (CDSC) in collaboration with the Regenstrief Institute, Kaiser Permanente Northwest Research Group, the Veterans Health Administration, Masspro, GE Healthcare, NextGen and Siemens Medical Solutions.

The goal of the CDSC is to assess, define, demonstrate, and evaluate best practices for knowledge management and clinical decision support in healthcare information technology (IT) at scale – across multiple ambulatory care settings and EHR technology platforms.

Our work is guided by a series of high-value research questions:

• How do we improve the translation of knowledge in clinical practice guidelines into actionable clinical decision support in healthcare information technology?
• How do we optimally represent knowledge and data required to make actionable clinical decision support content in human readable and machine readable and executable forms?
• How do we collate, aggregate, and curate knowledge content for clinical decision support in a knowledge portal used by members of the CDS Consortium? How may we use such a tool to support knowledge management and collaborative knowledge engineering for clinical decision support at scale, across multiple healthcare delivery organizations, and multiple domains of medicine?
• How do we demonstrate broad adoption of clinical decision support at scale in different healthcare IT products that are used in disparate ambulatory care delivery settings? Such demonstrations may show the utility of a simplified clinical decision support knowledge specification in human readable form, as well as the utility of publicly available CDS web services, and their incorporation in CCHIT-certified electronic health records (EHR).
• How do we define and evaluate best practices in response to the above assessments and demonstrations? Evaluation must include an assessment of how to incorporate clinical decision support services at scale in a variety of vendor healthcare information technologies, as well as products developed in academic settings. Further, how do we deploy clinical decision support services in healthcare information technology in a manner that improves CDS impact?
• How do we broadly disseminate the lessons learned over the course of these investigations to key audiences, such as the academic informatics community, patient safety and quality groups, medical specialty societies, small office practice settings, and others?


CDS Consortium Activities

The CDS Consortium will carry out a series of activities over the next two to five years:

• Carry out an assessment of knowledge management practices: CDSC researchers will travel to a representative Consortium member site to gather information on their decision support systems and knowledge management practices. This team will use a mix of on site assessment methods, including in-depth interviews, and observations, as well as conduct follow-up visits to the sites after demonstrations have been completed.
• Translate guidelines into actionable decision support tools: The CDSC Knowledge Translation and Specification team (KTS) will select medical guidelines and develop standards and mechanisms for these guidelines into unambiguous knowledge specifications. Those specifications will be used in the subsequent service and demonstration projects.
• Build a knowledge portal and repository (KPR): The KPR team will develop knowledge management tools for use in the development, review, publication, cataloging and archival of clinical guidelines in human and machine-readable forms.
• Develop CDS Services: The CDS services team will take the knowledge specifications developed by the KTS team and develop publicly available web services that will implement the KTS team’s logic. These services will be made available to clinical information systems.
• Carry out demonstrations of CDS across sites: The CDS Demonstrations Team will implement decision support interventions using the content and services developed in the consortium. The initial demonstrations will occur in the Partners Longitudinal Medical Record (LMR) and will incorporate other sites in future years.
• Build “dashboards” to measure the success of our CDS: The CDS Dashboards Team will develop performance reporting tools and clinical dashboards so that providers and site clinical quality staff can review adherence to CDS Consortium guidelines.
• Evaluate our work: The evaluation team will coordinate CDSC evaluation activities across all teams and act as expert consultants to each team as they develop and carry out their evaluation plans.
• Make recommendations: Based on what we learn, the CDSC will make recommendations to electronic health record vendors, clinical content vendors and regulatory and certification authorities about best practices and capabilities for decision support.
• Disseminate our results: Along with Masspro, the Massachusetts quality improvement organization, and the AHRQ National Resource Center for Healthcare IT, we will share and publish our findings and clinical decision support content and best practices developed by the CDS Consortium. We will incorporate lessons learned about CDS into online learning modules for physicians as part of Masspro’s DOQ-IT University initiative, and in the AHRQ National Resource Center.

Conclusion


The CDS Consortium is confident that working together, with Agency for Healthcare Research and Quality (AHRQ) support, significant progress towards widespread adoption of clinical decision support can be made in a short period of time. We expect to deliver first results by the end of the first year of the study. More detailed information is available upon request. Please visit our public website for CDSC study: http://www.partners.org/cird/cdsc

Monday, May 11, 2009

HL7: Clinical Decision Support

This is the presentation made to the CIC (Clinical Interoperability Council) at HL7 in April, 2009, on Clinical Decision Support.

Supporting Barack Obama for President

This slide show is from last fall when I had the oppotunity to speak on behalf of the Obama Campaign 2008. It was a privilege.

Tuesday, April 28, 2009

Testimony on HIT "Meaningful Use" at NCVHS April 28, 2009

The National Committee on Vital and Heath Statistics (NCVHS)
Executive Subcommittee special hearing on ‘meaningful use’ as proposed in the American Reinvestment and Recovery Act 2009
Panel 2: Meaningful Use capacity/functionality in EHRs
Marriott Wardman Park Hotel, Washington, D.C. 20008.
Tuesday, April 28, 2009

Panelist: Blackford Middleton, MD, MPH, MSc, FACP, FACMI, FHIMSS
Director, Clinical Informatics Research & Development
Chairman, Center for Information Technology Leadership
Partners HealthCare System, Boston, MA


Introduction:
Good morning. My name is Dr. Blackford Middleton. I am the Corporate Director for Clinical Informatics Research and Development, and of the Center for Information Technology Leadership, both at Partners Healthcare System, Boston, Massachusetts. I am also a member of the National Committee for Vital and Health Statistics, but today I am speaking in my capacity as someone who has been involved with electronic medical record use, design, implementation, and evaluation, in academic and industrial settings, for over 20 years.

It is an honor and a privilege for me to be with you today to discuss this critically important issue of ‘meaningful use’ of healthcare information technology (HIT) for US healthcare which I believe is essential as a prelude to healthcare reform, and transformation of our healthcare delivery systems into the information age, at last. I suggest that through no fault of our own, the physician-emperor has no clothes: we physicians have not invested figuratively, or financially, with HIT. There may be good reasons for this given that he who pays for HIT is not he who gains. Zbut, we can overcome this barrier with Stimulus, and healthcare reform.

Framing the discussion of ‘meaningful use’ of HIT

Briefly, allow me to describe several issues which motivate and frame my discussion of the meaningful use of HIT, which then will guide the discussion of essential functionality and capacities required of HIT which should warrant incentive payments.

The motivation for HIT is clear: in our current fractured, and unwired healthcare system, evidence suggests that physicians routinely practice in a state of incomplete information, and with an incomplete knowledge base required to effectively apply best evidence where it exists for clinical decision-making. With the knowledge-base in medicine continuing to explode, especially in light of the revolution in personalized care it is likely that the information needs problem for providers, and our patients, will only escalate.

When considering assessment and measurement of ‘meaningful use’ I suggest that we consider how HIT itself may play a role in producing reliable measures. HIT process measures could be a by-product of the use of the HIT itself, for example the per provider percentage of prescriptions written with an e-prescribing system. Measurement of meaningful use will require a strong ‘signal’ – something which can be measured reliably – and one that can discriminate between what is judged as meaningful use or not, and does so without bias, and cannot be used fraudulently to misrepresent use of the technology. Importantly, the measures should be independent of the particular technology per se, and apply whether a comprehensive thick client EMR, or a lightweight web-based system is being used.

While we consider our goals for transforming health care with the application of HIT, we must be wary of setting our sights too low, or settling for only an intermediate goal state in the journey toward robust HIT adoption. At the Center for Information Technology Leadership, for example, we find in our analyses that potentially many billions of dollars may be saved with the broad application of HIT. Our findings suggest that the two most important factors associated with the maximum value potential of HIT are seamless interoperability of healthcare data, and advanced clinical decision support. It is incumbent upon us to keep this long-range goal in mind even as we begin the journey with small steps.

Let us turn now to the goals of HIT adoption. Our first goal is improved care delivery: lower costs, improved quality, but I hope also we design a system that can enhance individual and community wellness, and research on what works and what does not. It is not about healthcare technology itself, of course, but rather what outcomes and redesign of our delivery system we can achieve with it. I suggest that defining clinical goals only is insufficient, and will not lead to a future state of coordinated and seamless care across different locations of care, healthcare organizations, and different technology solutions. Such systematic goals require us to think about requirements of the system itself to work efficiently; things like the ability to correctly identify the patient in any technology system, the seamless exchange and portability of data and information across systems, the availability of the best knowledge at the point of care in clinical decision support within any technology, and more. While these goals may not relate to one or another specific clinical goal, more importantly, they are relevant to helping us redesign our healthcare delivery system, as HIT is the enabler, and prelude, to other dimensions of healthcare reform to come. To achieve this vision, we will need a phased approach to incremental technology adoption that incrementally and inexorably moves us toward our combined goals.

Let me know now turn to the questions at hand regarding EHR functionality.

Questions:

1. What EHR capacities/functionalities are absolutely required to enable a safe, patient-centric, high-quality health care system that optimizes patient outcomes?

Several excellent descriptions of EHR capacities and functionalities exist currently. These include the 2003 Institute of Medicine Letter Report describing the EHR, HL7’s EHR Standard Functional Specification, as well as the certification criteria for ambulatory medical records 2008, and inpatient criteria in development from the Certification Commission for Healthcare Information Technology. Time will not allow reviewing each of these now, but common to all of these functional descriptions of EHR are the following core capabilities:

Data Access: aggregate all the relevant patient care data for review by the provider. This may include organizing the data in a variety of presentations, and numerically and semantically normalizing data from disparate data sources.

Knowledge Access: provide access to knowledge-based tools and services in the context of the clinical workflow. Readily provide an answer to the clinical question at hand, ‘one click away’.

Workflow and Clinical Decision Support: provide support for the clinical workflow both for the individual care provider, and care teams. In addition, provide clinical decision-support in the context of the clinical workflow, such as alerts, reminders, documentation assistance tools, care plans and guidelines, and diagnostic and therapeutic decision support as appropriate to both providers and patients.

Healthcare Information Exchange: facilitate information exchange between disparate sources for the purposes of data review for each and every clinical encounter. This should include all essential data elements such as current medications, allergies, problems and past medical history, laboratory and diagnostic test results, and patient demographics for example.

Let us now turn to the specific technologies that should be in use in 2011.

2. What are the critical EHR functionalities (e.g., e-prescribing, decision support, problem list management) of which providers should be required to demonstrate use in order to be earn an incentive as a “meaningful user” of certified EHR technology in 2011? Should the functionalities or other specific requirements to meet the statutory “meaningful use” criteria be different or specific to provider type (i.e., eligible professionals, hospitals)?

The language in HITECH within ARRA describes three broad areas; I concur with these capabilities being the areas of focus for 2011. In each case, in the written testimony I provide pointers to illustrative capabilities as defined in CCHIT certification criteria (these lists are not comprehensive).

- e-Prescribing: defined as electronically prescribing, and managing a medication list, with patient specific medication decision support (drug-drug, drug-lab, drug-allergy), medication history, allergies, including inpatient medication reconciliation, and medication administration
o For example, the functions described in CCHIT Ambulatory 2008 Criteria sets in AM04, AM05, AM11, AM19, and FN05, FN06, FN07, FN08, FN12, FN13;
o and Inpatient Criteria IP05 and FN05, IP06 and FN06, IP10, FN07, FN12, IP11, IP12, FN08, IP14, FN16, IP16)

- Healthcare Information Exchange: defined as the ability to aggregate, collate, and display in appropriate views all relevant patient care data from ancillary systems (for example, laboratories, radiology reports, patient demographic and administrative data, etc.). In addition, provide the ability to produce a Visit Summary (CCD), and exchange select data across and between healthcare organizations.
o For example, CCHIT 2008 AM09, AM14, IO-AM11, or HITSP ISO3/C32 specification with SNOMED-CT and Level 3 RxNORM
o And Inpatient Criteria IO IP-04 (Discharge), and IO IP-05 (Cross enterprise document sharing)

- Quality Data Reporting: defined as the ability to submit a standard quality data set to the appropriate authoritative agencies reflecting care quality, patient safety, and compliance with select standard quality measures
o CCHIT Ambulatory 2008 AM29, IO AM-14,
o For example, NQF HITEP-2 quality data set (QDS)


Should a distinction be allowed between provider types? With respect to the functionality described above, this observer would suggest that distinctions not be allowed between provider types. The above functionality should be in place and used by the relevant accountable providers for each and every clinical encounter or hospitalization.

4. What additional functionalities would be most important to require providers use by 2014 or 2015?

As the country moves toward universal adoption of electronic health records, the depth of functionality and interoperability to fully achieve the value potential of healthcare information technology must match the breath of adoption. By 2015, in addition to the above, the following functionalities should also be widely adopted to warrant incentive payments.

- Demonstrate the ability to reliably submit without tampering or fraud predefined measures of HIT use, and quality data reports
o This is critical to allow meaningful use to be assessed as a by-product of use
- Enhanced Structured and Coded Documentation
o Problem List, Medication List, Advanced Directives, Blood type, Adverse Events (never events), Family History, Medical History, Surgical/Procedure History, Social History, Chief Complaint, Healthcare Maintenance and Screening, observations required for quality measurement, for example.
o To improve the data we collect and input to clinical decision support and quality data reporting systems progressive standardization of documentation templates and controlled medical terminology
- Effective Workflow and Clinical Decision Support
o Team-based care coordination, healthcare maintenance and screening reminders, preventive care services, chronic care management, acute care management, triage, remote consultation and care collaboration
o Based upon the evidence, define minimal standard clinical decision support for 2014 (and possibly beyond)
- Knowledge Management Services
o Given the depth and breadth of clinical content and knowledge artifacts required to support effective workflow and clinical decision support, healthcare information technology solutions should have access to a national knowledge repository, and knowledge management services, to facilitate keeping all systems up to date with current best evidence and best practices
- Seamless and secure information exchange and interoperability
o Progressive standardization of essential clinical data sets to support healthcare information exchange and interoperability
- Personal Health Records
o A patient-controlled Personal Health Record provided either as an adjunct to provider-based systems, or through independent solutions, to support patient engagement and facilitate information exchange

3. Are these functionalities supported in current certified EHR products? If not, what are the gaps?

Time will not allow a comprehensive review of whether the functionalities described above are supported in current certified EHR products or not. The more advanced functionalities do not yet have certification criteria, and by the same token the certification process should not quell innovation in the marketplace to bring advanced technologies to life. Several core issues underlie this entire discussion on EHR functionalities, however, that if addressed from a national perspective could help facilitate obtaining both widespread adoption of HIT, and impact health care costs, and quality.

- National Patient Identifier
We have had a long debate in this country about the merits of a national patient identifier. This observer would suggest that the benefits far outweigh the risks and that we should move forward in developing and implementing this identifier with all appropriate policies and protections in place to ensure its safe and effective use.

- Standardized clinical data model and clinical terminology
While we have made dramatic progress in recent years thanks largely to the efforts of leading standards development organizations such as HL7, Integrating the Healthcare Enterprise, and the Healthcare Information Technology Standards Panel’s efforts on harmonization, we do not have a universally accepted and complete clinical data model, nor do we have standardized clinical terminology, for all essential clinical data elements. Every effort should be made to advance our progress in these areas as they undergird the successful design, implementation, and use of all healthcare information technologies.

- Standardized User Interface
We now recognize that the human computer interface of healthcare information technology itself may impact clinical workflow and outcomes. There is a growing literature on the unintended and untoward consequences of HIT use. This observer would suggest that a critical element for the successful design, implementation, and use of HIT is to standardize the user interface so that providers using any system can use it appropriately. This will, of course, also decrease training costs, and assist providers who provide care in more than one setting.


Acknowledgements
I would like to acknowledge several colleagues who provided valuable input to this testimony. Dr. Eric Pan and Mr. Douglas Johnston from the Center for Information Technology Leadership, and Drs. Adam Wright, and Dean Sittig, co-investigators in the AHRQ Clinical Decision Support Consortium.

Thank You!

Wednesday, April 22, 2009

HL7 Clinical Interoperability Council April 21, 2009

Yesterday I had the good fortune of presenting to the HL7 clinical interoperability Council meeting in Washington DC. What the CIC is responsible for helping is HL7 understand the clinical issues surrounding HL7 standards efforts and healthcare information technology implementation and effective use. My presentation can be seen at the following URL: http://tr.im/jqFK. All presentations will be available publicly at HL7 website soon.

My central observation after spending a good part of a day with this group is that it may play a critical role in helping HL7 understand its potential role with respect to implementation of healthcare information technology. In particular, the CIC may help establish essential clinical governance mechanisms for defining and optimizing the implementation of HL7 standards, and perform a necessary role as the arbiter of best practices for knowledge management, and the clinical content that is used in healthcare information technology for clinical decision support.

This latter function is a critically important role for helping the country implement healthcare information technology which produces value -- this is dependent upon having both meaningful use of healthcare information technology, but also defective use which requires considerable evidence-based content within healthcare information technology providing clinical decision support at the point of care.

Thursday, April 16, 2009

Harvard CME Course on eHealth - stimulated yet?

Please consider joining us for the Harvard Medical CME Course on eHealth: http://tr.im/iyOz... you will be Stimulated!

We have a fantastic lineup of local Harvard and national faculty that will help address key issues in clinical informatics for both the beginner and advanced users alike. Selected keynotes include:

e‑Health for Patient Safety, Quality, and Care: Transforming Healthcare Delivery
Paul Tang, MD, Palo Alto Medical Foundation

Transforming Public Health Information Capabilities in the eHealth Era
David A. Ross, ScD, Public Health Informatics Institute, GA

eHealth and Behavioral Informatics: Effecting behavior change with HIT
David Ahearn, PhD, Health e-Technologies Institute, Brigham & Women's Hospital

Keynote Address ‑ 3rd Annual Warner Slack Keynote Lecture Digital Medicine in the Era of Health Reform
Brent James, MD, MStat

Personal Health Record Systems of the Future: A Bold Vision
Patricia Flatley Brennan, RN, PhD, FAAN, FACMI

National Policy Standards Review and Update
John D. Halamka, MD

EHRs and PHRs: Impact on Patient Safety, Healthcare Quality, and Costs
Blackford Middleton, MD, MPH, MSc, FACP, FACMI, FHIMSS, Brigham & Women's Hospital, Center for IT Leadership

In addition, we have a wide variety of stimulating panel sessions with a stellar lineup of panelists, including: Michael Klompas, MD, David A. Ross, ScD, Farzad Mostashari, MD, MSc, Patricia Franklin, MD, MBA, MPH Holly Miller, MD, Nirav R. Shah, MD, MPH, Timothy W. Bickmore, PhD, Jonathan Wald, MD, MPH, Joseph C. Kvedar, MD, Larry Garber, MD, Luke Sato, MD, Micky Tripathi, PhD, MPP, Jerome Carter, MD, FACP, Claus Hamann, MD, MS, Daniel Z. Sands, MD, MPH, David C. Judge, MD, Steve Lynch, BSc, Charles H.Weiss, MD, Georgiana K.White, MS HSA, RN.

We will also have 8 workshops to draw from (each attendee gets to attend 4) across the 2 1/2 days of the course that will allow you to interact directly with experts on a wide array of topics, including:

1. Costs and Benefits of Implementing EHR and PHR Solutions into Practice Settings
2. Personal Health Records: The Basics
3. Successfully Implementing an Electronic Health Records System
4. Using an Electronic Health Record for Population Health Management
5. Advances in Behavioral Telehealth
6. EHR Solutions for Reducing Errors and Transforming Healthcare Quality
7. Engaging Patients in Using PHRs Effectively
8. Working with Your Patients to Evaluate and Enhance the Quality of Care

Please come for what has proven to be a fun and useful course!

Wednesday, April 15, 2009

First Post

This is the blog of the Clinical Informatics R&D group, and the Center for IT Leadership, at Partners Healthcare System, Boston, MA. We will aim to educate, illuminate, entertain, and hopefully advance the field of clinical informatics. These postings are meant to reflect the opinions of the author of the post only, and do not represent official opinions of Partners Heatlhcare System, any of it's constituent entities, or the CITL. Stay tuned, and enjoy!
 

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