Appendix B

Case Studies for the Digital Health Infrastructure

THE caBIG® INITIATIVE

Prepared by Ken Buetow (National Cancer Institute)

Overview

The National Cancer Institute (NCI) has developed an informatics program designed to improve patient care and accelerate scientific discoveries by enabling the collection and analysis of large amounts of biological and clinical information and facilitating connectivity and collaboration among biomedical researchers and organizations. Called caBIG® (cancer Biomedical Informatics Grid), this program is developing the foundational informatics infrastructure to improve health and combat disease emerging at the intersection of life sciences, information technology, and medicine. The caBIG® program has three core components: community, connectivity, and content.

The caBIG® Community

The caBIG® program has been from the start a collaborative endeavor. Its community has grown dramatically in size and scope since the program began in 2004. More than 2,200 individuals representing more than 700 different organizations are actively engaged in caBIG®, and participation is steadily increasing. These individuals include basic and clinical researchers, consumers, physicians, advocates, software architects and developers, bioinformatics specialists, and executives from academe, medical centers,



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Appendix B Case Studies for the Digital Health Infrastructure THE caBIG® INITIATIVE Prepared by Ken Buetow (National Cancer Institute) Overview The National Cancer Institute (NCI) has developed an informatics program designed to improve patient care and accelerate scientific discov- eries by enabling the collection and analysis of large amounts of biological and clinical information and facilitating connectivity and collaboration among biomedical researchers and organizations. Called caBIG® (cancer Biomedical Informatics Grid), this program is developing the foundational informatics infrastructure to improve health and combat disease emerging at the intersection of life sciences, information technology, and medicine. The caBIG® program has three core components: community, connectivity, and content. The caBIG® Community The caBIG® program has been from the start a collaborative endeavor. Its community has grown dramatically in size and scope since the program began in 2004. More than 2,200 individuals representing more than 700 different organizations are actively engaged in caBIG®, and participation is steadily increasing. These individuals include basic and clinical research- ers, consumers, physicians, advocates, software architects and developers, bioinformatics specialists, and executives from academe, medical centers, 255

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256 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM government, and commercial software, pharmaceutical, and biotechnology companies from the United States and in 15+ countries around the globe. In support of the development of a Rapid Learning Health System, the caBIG® participation includes both academic and community cancer centers. The caBIG® program is organized into workspaces focused on spe- cific domains such as medical imaging, IT architecture, and clinical trials. Subject matter experts and developers within each workspace use virtual conferences and regular face-to-face meetings to work collaboratively on domain-specific issues and projects. The entire caBIG® community meets once per year for the Annual Meeting, whose growth in size and scope year-over-year has mirrored that of the caBIG® program. More than 1,100 individuals representing more than 300 organizations and 13 countries attended the 2009 meeting, held in Washington, DC, where participants celebrated the first 5 years of the caBIG® program by planning new ap- plications and research uses. While the caBIG® community is highly diverse, its members have simi- lar needs for data management and analysis. Through participation in the caBIG® program, they are able to access the informatics infrastructure required to work productively, advancing the knowledge of the underlying causes of disease and providing improved patient outcomes. Connectivity From a technology perspective, caBIG® is centered on four key principles: • Open development—Planning, testing, validation, and deployment of caBIG® tools and infrastructure are open to the entire research community, and contributions from many organizations ensure applicability to a wide range of common research problems. Open access—caBIG® is open to all individuals and organiza- • tions interested in solving their data management and connectivity challenges, thus ensuring widespread access to tools, data, and infrastructure. Open source—The underlying software code of caBIG® tools is • freely available for use and modification by any organization, pub- lic or private, thus encouraging commercial partnerships. • Federation—Data and analytical resources can be controlled locally or integrated across multiple sites. Control of secure access to those resources is retained by the originating organization. This federated approach obviates the need for a central authority and reduces data management overhead.

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257 APPENDIX B Together, these four organizing principles ensure the availability of robustly designed tools that address a wide range of basic and clinical research requirements. Central to these needs is the requirement for in- teroperability—the ability to access and make meaningful use of data and information by multiple systems. By building and deploying IT based on industry-recognized standards, and providing application programming interfaces and software development kits for third-party developers, the process of creating new caBIG®-compatible software or adapting existing software to become caBIG®-compatible is simplified, encouraging partner- ships across the IT community. At the heart of the caBIG® program—invisible to the end user and customized for the specific needs of biomedical researchers—is caGrid, a model-driven, service-oriented architecture that provides standards-based core “services,” tools, and interfaces so the community can connect to share data and analyses efficiently and securely. More than 120 organiza- tions are connected to caGrid. The number continues to expand as more NCI-designated Comprehensive Cancer Centers, as well as academic and commercial organizations set up nodes on the grid, making caGrid the larg- est biomedical research network in the world today. Such caBIG®-enabled connectivity is not limited to organizations conducting cancer research. In partnership with the American Society of Clincal Oncology, caBIG® is developing specifications and services to sup- port oncology-extended electronic health records (EHRs) that are being deployed in community practice and hospital settings. caBIG® tools and technology are also being used by researchers working on cardiovascular health, arthritis, and AIDS. In addition, pilot projects have successfully connected caGrid to other networks, including the Nationwide Health Information Network, the CardioVascular Research Grid, and the compu- tational network TeraGrid. Ultimately, the vision of the caBIG® program is to provide the techni- cal infrastructure for a resource called the Biomedical Knowledge Cloud. The Biomedical Knowledge Cloud is a means of using the Internet to con- nect massive amounts of individual and organizational biomedical data, software applications with which to handle and analyze all those data, and the computational horsepower to do the work. The Cloud is bounded with patient privacy and other data-sharing protections. Although the components of the Cloud are not new, the concept of joining them together to provide seamless, secure access to biomedical information is just being realized today. Simply connecting organizations and individuals would be of little value if they were not able to access and understand the data and informa- tion created by different laboratories. Currently, many software systems, either commercial or created in-house to serve the needs of a particular

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258 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM institution, are based on proprietary data formats and, as a result, cannot readily exchange data. They lack the ability to be interoperable. Since its inception, the caBIG® program has worked with key health- care industry organizations to create or expand standards and common vocabularies that describe data types, analytical processes, and even clinical procedures. By developing tools that adhere to these standards and lever- age these vocabularies, institutions can exchange data seamlessly, much the same way that agreed-upon interoperable standards enabled the global banking system to develop the interconnected network of ATMs for con- sumer use. caBIG® is based on the belief that strong confidentiality, privacy, and security measures are both necessary and feasible in any electronic health information exchange environment, and that the measures can be scaled to accommodate a broad range of participants without unnecessarily imped- ing scientific discovery and medical progress. The program has developed robust computer security measures to ensure that only researchers with the appropriate credentials have access to data, as well as guidelines to assist those researchers in determining the sensitivity of their data for sharing. Content As scientific understanding of the complexities underlying most diseases increases, the interconnectedness of biological systems becomes more and more obvious, and researchers must apply multidisciplinary analysis tech- niques to large, diverse datasets to make new discoveries. For example, by correlating the activity of a specific set of genes with observed outcomes from large groups of patients on the same treatment protocol, cause-and- effect relationships can be found that would be missed when examining the expression patterns alone, or when looking at a small group of patients. By enabling researchers to work collaboratively—leveraging large, di- verse datasets—all constituents of the health care community reap the ben- efits. Biomedical researchers can ask and answer more complex questions that help uncover the underlying causes of disease, speeding the develop- ment of novel diagnostics and therapeutics. Healthcare providers can stay current on new treatments and outcome information gathered from large populations of patients who have similar diseases. This capability allows them to provide the best treatment options for their patients, ultimately im- proving patient outcomes. The patients themselves are assured of receiving optimal treatment regardless of their physical location, since their complete medical history is secure yet available as needed to guide their treatment.

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259 APPENDIX B FDA’S SENTINEL INITIATIVE Prepared by Judy Racoosin (Food and Drug Administration) Background In May 2008, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced the launch of FDA’s Sentinel Initiative, a long-term program designed to build and imple- ment a national electronic system (Sentinel System) for monitoring the safety of FDA-approved drugs and other medical products. The Sentinel System will function as an active postmarket safety monitoring system, augmenting FDA’s existing safety monitoring systems. The launch of the Sentinel Initiative followed passage of the Food and Drug Administration Amendments Act (FDAAA), which became law in September 2007. Section 905 of FDAAA mandates FDA to develop an enhanced ability to monitor the safety of marketed drugs using automated healthcare data sources. The Sentinel Initiative is designed to manage the development and implemen- tation of the Sentinel System while ensuring that it fulfills the mandates included in FDAAA. Once developed and implemented, the Sentinel System will enable FDA to monitor the safety of drugs and other medical products with the assis- tance of a wide array of collaborating institutions throughout the United States. Data partners in the Sentinel System will include organizations such as academic medical centers, healthcare systems, and health insur- ance companies. As currently envisioned, participating data partners will access, maintain, and protect their respective data, functioning as part of a “distributed system.” Collaborating organizations will also include patient and healthcare professional advocacy groups, academic institutions, and regulated industry, among others. In the active surveillance environment of the Sentinel System, FDA will prioritize safety questions that have emerged from premarket or postmarket safety data sources (e.g., clinical trial data, postmarket adverse event re- ports) and submit them to a Coordinating Center for evaluation by data partners that are participating in the Sentinel System. Data partners will se- curely access their databases to evaluate the submitted question and return Health Insurance Portability and Accountability Act (HIPAA)–compliant result summaries to the Coordinating Center. The Coordinating Center will then aggregate and/or summarize these results and forward them to FDA for their use in assessing the safety question.

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260 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM Mini-Sentinel In September 2009, FDA awarded a contract to Harvard Pilgrim Health Care, Inc. (Harvard Pilgrim) to develop a smaller working version of the future Sentinel System. The pilot has been dubbed “Mini-Sentinel.” Harvard Pilgrim’s Mini-Sentinel Coordinating Center (MSCC) is creat- ing a kind of laboratory, giving FDA the opportunity to access disparate automated healthcare data sources and test epidemiological and statistical methodologies in the evaluation of postmarket safety issues. Through this pilot, FDA will learn more about some of the barriers and challenges, both internal and external, to establishing a Sentinel System for medical product safety monitoring. The MSCC is leading a consortium of more than 20 col- laborating institutions.1 The MSCC and participating data partners are using a common data model as the basis for their analytical approach. The approach requires the data partners to transform their data into a standardized format. Based on this standardized format, the MSCC will write a single analytical software program for a given safety question and provide it to each of the data part- ners. This will allow each data partner to run the program on its standard- ized data. Data partners will conduct analyses behind their existing, secure firewalls and send only summary results to the MSCC for aggregation and further evaluation. The MSCC will provide FDA with both the aggregated results and the summary results from each data partner. The use of a com- mon analytical program will minimize the potential for differences in results across data holders resulting from differences in the implementation of an active surveillance protocol. As this pilot is being implemented, a governance structure is being developed to ensure that the activity encourages broad collaboration within appropriate guidelines for the conduct of public health surveillance activities. In order to accomplish that, the MSCC is developing a Statement of Principles and Policies that will include descriptions of the organizational structure and policies related to communication, privacy, confidentiality, data usage, conflicts of interest, and intellectual property. Also, with the launch of Mini-Sentinel, a Privacy Panel was formed to provide expertise regarding patient privacy-related regulations that pertain 1 The collaborating institutions in the consortium include the following organizations: CIGNA Healthcare; Cincinnati Children’s Hospital Medical Center; Brigham and Women’s Hospital; Duke University School of Medicine; HMO Research Network sites (includes Group Health Cooperative, Harvard Pilgrim Health Care Institute, HealthPartners, Henry Ford, Lovelace Clinic Foundation, Marshfield Clinic Research Foundation, Meyers Primary Care Institute [Fallon]); HealthCore; Humana-Miami Health Services Research Center; Kaiser Permanente (includes KPNC, KPSC, KPCO, KPNW, KPG, KPHI, KPOhio, KPmidatlantic); Outcome Sciences, Inc.; University of Illinois at Chicago; University of Iowa, College of Public Health; University of Pennsylvania School of Medicine; Vanderbilt University School of Medi- cine; Weill Cornell Medical College.

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261 APPENDIX B to the conduct of Mini-Sentinel. The panel members are independent pri- vacy experts with extensive knowledge of legal and ethical issues related to the use of protected health information (PHI), including applicable laws and regulations, data privacy and confidentiality, and the use of PHI for public health surveillance activities. The panel is • Providing expertise on application of relevant laws and regula- tions governing the privacy and security of health information for Mini-Sentinel’s purposes. The panel advises specifically on the ap- plicability of laws, including HIPAA and other relevant laws and regulations. • Making recommendations on creation of appropriate policies and procedures to guide specific uses of PHI in Mini-Sentinel. • Assisting the MSCC in reviewing documents, agreements, and con- tracts to ensure that they adequately incorporate the panel’s discus- sions regarding the issues delineated above. Federal Partners’ Collaboration FDA is furthering the science of medical product surveillance by broad- ening existing pilot programs that use federally held data sources. The effort, known as the Federal Partners’ Collaboration (FPC), involves the Centers for Medicare & Medicaid Services (CMS), the Veterans Adminis- tration (VA), and the Department of Defense. FPC is an expansion of the SafeRx project, a collaboration between FDA and CMS that uses Medicare and Medicaid data for medical product safety surveillance. The FPC is similar to the Mini-Sentinel pilot in that it will use an active surveillance approach and involves a distributed system. However, unlike Mini-Sentinel, the FPC will not use a common data model. Rather, the FPC will develop a common active surveillance protocol, and then each data partner will write analytical code to run the protocol in their database. Lessons learned from this pilot will be compared to lessons learned as part of Mini-Sentinel (i.e., using a common data model where centralized analytics are employed). In this way, FDA can compare the potential benefits and drawbacks of every data partner running a single analytical program based on a common data model versus each data partner developing its own analytical program based on a common protocol. Outreach Related to Active Medical Product Surveillance Continuing a high level of stakeholder involvement is key to maintain- ing broad-based support and momentum for effective, responsive, active medical product surveillance through FDA’s Sentinel Initiative. FDA has

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262 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM awarded a cooperative agreement to the Brookings Institution (Brookings) to convene a broad range of stakeholders to explore and address method- ological, data development, technical, and communication issues related to active medical product surveillance. These meetings encompass a range of formats including webinars on active surveillance–related topics, expert panels on targeted topics central to the development of the Sentinel System, public meetings on the prog- ress of the Sentinel Initiative, and meetings intended to interweave lessons learned by various active surveillance initiatives. In addition to convening and moderating each meeting, Brookings is synthesizing findings and making them publicly available in order for other organizations and individuals to use the information to further develop ac- tive medical product surveillance methods and systems. In addition, FDA has sought to foster transparency through the cre- ation and maintenance of a Sentinel Initiative Website, which provides information on the background of the initiative, relevant news and events, presentations, completed deliverables from contracted work, and updates on ongoing projects and funding opportunities. A docket is open to allow for public comment on any of this information. The agency also piloted a web-based discussion room to encourage public comment and promote transparency. Sentinel Initiative staff also foster transparency by speak- ing about the Sentinel Initiative to external stakeholder groups including academia, regulated industry, patient and consumer groups, and medical professional societies, as well as doing internal outreach to FDA staff. Contracts and Cooperative Agreements Informing FDA on the Development of the Sentinel System The following documents are now available in the FDA docket and on the Sentinel website http://www.fda.gov/Safety/ FDAsSentinelInitiative/ default.htm. • Developing a Governance and Operations Structure for the Senti- nel Initiative, an eHealth Initiative Foundation report. • Engagement of Patients, Consumers, and Healthcare Professionals in the Sentinel Initiative, an eHealth Initiative Foundation report. Defining and Evaluating Possible Database Models, a Harvard • Pilgrim Health Care, Inc. report. Evaluation of Existing Methods for Safety Signal Identification, a • Group Health Cooperative Center for Healthcare Studies report. • Evaluation of Potential Data Sources for a National Network of Orthopedic Device Implant Registries, an Outcome Sciences, Inc. report.

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263 APPENDIX B • Evaluation of Timeliness of Medical Update for Surveillance in Health Care Databases, an IMS Government Solutions report. • Evaluating Potential Network Data Sources for Blood and Tissue Product Safety Surveillance and Studies, a Pragmatic Data report. • Evaluation of State Privacy Regulations and Relation to the Senti- nel Initiative, a Qual-Rx report. Work on the following projects is ongoing. Evaluation of Potential Data Sources, a Booz Allen Hamilton report. • • Evaluation of Potential Data Sources for Animal Drugs Used in Veterinary Medicine, an Insight Policy Research, Inc. report. • Detection and Analysis of Adverse Events to Regulated Products in Automated Healthcare Data: Efforts to Develop the Sentinel. Additional Background FDA’s Sentinel Initiative, launched in 2008, is a long-term program designed to build and implement a national electronic system (the “Senti- nel System”) for monitoring the safety of FDA-approved drugs and other medical products. The Sentinel System will fulfill, and go beyond, the con- gressional mandate put forth in the FDAAA of 2007 that requires FDA to create a system for postmarket risk identification and analysis using public and private automated data sources. Engaging Patients and the Public Broad engagement of all stakeholders is essential to developing a gover- nance framework that addresses the many issues that need to be considered for the successful implementation of a system that leverages secondary use of automated healthcare information to improve the public health. Early activities of the Sentinel Initiative included meetings with a • broad range of stakeholders including other government agencies, potential data partners, patient advocacy groups, professional so- cieties, academia, and regulated industry. To ensure continued input of all stakeholder groups, in 2009 FDA • awarded a cooperative agreement to the Brookings Institution to function as a convener on topics related to active medical product safety surveillance. They have sponsored large public meetings on the Sentinel Initiative, smaller expert panel discussions on focused topics, and webinar-style roundtables to discuss new methodolo- gies and findings.

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264 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM Paramount to this effort is safeguarding the privacy and security of the data leveraged for these activities, and ensuring that patients and consumers understand that their privacy is being protected. This includes compliance with federal and state laws and regulations and consideration of additional forms of protection. As part of the Mini-Sentinel pilot, a privacy panel consisting of • established experts in the field, including patient advocates, has been convened to address privacy and security concerns. Promoting Technical Advances and Innovation After careful consideration of all options, FDA concluded that a distrib- uted system is essential to the success of efforts such as the Sentinel Initia- tive. The key benefits of this distributed approach include the following: Patient privacy is maintained by keeping directly identifiable pa- • tient information behind local firewalls in its existing protected environment. Data partners’ involvement in running analyses ensures an in- • formed approach to interpreting results because they are aware of the changes that have occurred in their healthcare systems that result in the unique character of their database. Patient and consumer concerns about potential misuse are greatly • reduced. A distributed system can operate efficiently, compared to a centralized system, by having the data partners adopt a common data model and then creating the capability for efficient distribu- tion of queries (executable computer programs) and return of their output. Through the Mini-Sentinel pilot, FDA has developed the first stage • of such a system, which will ultimately include administrative claims, EHRs, and registry data. We must develop methods to link information about patients between data sources (e.g., inpatient hospital records, outpatient records, and pa- tient registries) in order to produce a complete longitudinal profile of patient care. We must train the next generation of statisticians and epidemi- ologists to ensure that we will have a workforce with the skills to support active medical product safety surveillance.

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265 APPENDIX B Fostering Stewardship and Governance Governance and stewardship should allow multiple activities, includ- ing both public health practice and research, to share a common national resource that allows the use of automated healthcare data for secondary uses, such as safety surveillance, comparative effectiveness research, and quality assessment. HEALTHWISE Prepared by Cartherine Serio and Don Kemper (Healthwise) About Healthwise Nonprofit mission: Help people make better health decisions (since 1975) 110 million user sessions with Healthwise content in 2009 Current Clients: The top 10 U.S. health plans (Kaiser, Aetna, Cigna, Wellpoint, etc.) • 300-plus U.S. hospitals (Mass General, Sutter, Sisters of Mercy, • Health Partners, etc.) Leading disease management companies (Health Dialog, Alere, • etc.) Government agencies (Department of Veterans Affairs, Department • of Defense, State Medicaid, British Columbia, etc.) Most large health portals (WebMD, AOL, Yahoo, MSN, Health. • com, etc.) Innovation History 1970s: Medical self-care handbooks and workshops (28 million • books sold) 1980s: Wellness books and workshops • 1990s: Healthwise Knowledgebase for Websites and nurse call • centers o Patient decision aids (now 158) o Symptom guides, action plans, tests, treatments, and self-care 2000s: Information therapy, interactive conversations, guided • self-management Promoting the consumer as the greatest untapped resource in health care.

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266 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM Healthwise Engagement Tips 1. Think like a consumer (patient-centric engagement) • Understand consumers’ motivation for engagement • Anticipate consumers’ needs • Design toward those needs 2. Engagement ingredients • Establish trust • Use plain language • Allow choice 3. Engagement strategies • ull: How to engage people who are ready to “pull” information P from the Web. • ush: How to engage people by “pushing” information relevant P to their needs. • ay: How to engage even more people through incentives for P active patienthood. 4. Engage the consumer’s community • ocial networking allows consumers to get, and give, emotional S support KAISER PERMANENTE2 Health Information Technology (HIT) at Kaiser Permanente Kaiser Permanente has been using information technology for more than 40 years to improve clinical and administrative functions. Its use of electronic health records (EHRs) dates from the 1990s in some regions. Building on this experience, and with the active participation of its physi- cians, Kaiser Permanente in 2003 launched a $4 billion health information system called KP HealthConnect that links its facilities nationwide and rep- resents the largest civilian installation of EHRs in the United States. As of April 2008, the system was successfully implemented in outpatient clinics in all eight Kaiser regions. Every Kaiser hospital has the essential components of the system and 25 had implemented all modules as of December 2008. 2 Prepared by Roundtable Staff using the following sources: Healthcare Information and Management Systems Society (HIMSS) Analytics. Kaiser Permanente—EHR Adoption Model. http://www.himssanalytics.org/hc_providers/ stage7casestudies_KP.asp. McCarthy, D., and K. Mueller. 2009. Kaiser Permanente: Bridging the Quality Divide with Integrated Practice, Group Accountability, and Health Information Technology. The Commonwealth Fund. http://www.commonwealthfund.org/~/media/Files/Publications/ Case%20Study/2009/Jun/1278_McCarthy_Kaiser_case_study_624_update.pdf.

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267 APPENDIX B The EHR at the heart of KP HealthConnect (purchased from vendor Epic Systems Corp.) provides a longitudinal record of member encounters across clinical settings and includes laboratory, medication, and imaging data. HP HealthConnect also incorporates • Electronic prescribing and test ordering (computerized physician order entry) with standard order sets to promote evidence-based care. • Population and patient-panel management tools such as disease registries to track patients with chronic conditions. • Decision support tools such as medication-safety alerts, preventive care reminders, and online clinical guidelines. • Electronic referrals that directly schedule patient appointments with specialty care physicians. • Performance monitoring and reporting capabilities. • Patient registration and billing functions. KP HealthConnect is designed to electronically connect members to their health care team, to their personal health information, and to rel- evant medical knowledge to promote integrated health care. For example, members can complete an online health risk assessment, receive customized feedback on behavioral interventions, participate in health behavior change programs, and choose whether to send results to KP HealthConnect to facilitate communication with their physician. To more fully engage patients in their care, physicians and staff en- courage them to sign up for enhanced online services. As a result, more than one-third of health plan members nationwide (and nearly one-half of members in Northern California) are using a web portal called My Health Manager to track selected medical information from the EHR, view a his- tory of physician visits and preventive care reminders, schedule and cancel appointments, refill prescriptions, and send secure electronic messages to their care team or pharmacist. Online laboratory test results—the most popular online function—include links to a knowledge base of information on test results and related self-care strategies. A pilot project is testing the capability for members (initially Kaiser employees) to transfer information securely from My Health Manager to Microsoft Corporation’s HealthVault personal health record application. Physician leaders report that access to the EHR in the exam room is helping to promote compliance with evidence-based guidelines and treat- ment protocols, eliminate duplicate tests, and enable physicians to handle multiple complaints more efficiently within one visit. A study in the North- west region found that patient satisfaction with physician encounters in- creased after the introduction of the EHR in exam rooms there. Early

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268 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM findings from ongoing hospital implementations suggest that the combina- tion of computerized physician-order entry, medication bar coding, and electronic documentation tools is helping to reduce medication administra- tion errors. Use of the EHR and online portal to support care management and new modes of patient encounters appears to be having positive effects on utilization of services and patient engagement. For example, three-quarters or more of online users surveyed agreed that the portal enables them to manage their health care effectively and that it makes interacting with the health care team more convenient. Patients in the Northwest region who used online services made 10 percent fewer primary or urgent care visits than before they had online access (7 percent fewer visits compared with a control group of patients). HIT in Practice: Care Coordination and Transitions Having a broad spectrum of services available within one organization and, in many cases, in one location, makes it easier to coordinate care for patients. Kaiser Permanente’s integrated model of care focuses not only on the spectrum of medical care that a patient may need at any one time, but also on members’ interactions with the organization across time and the continuum of care—clinic, hospital, home, hospice, or extended care. The Northern California region uses a population and patient-panel management strategy to improve care and outcomes for patients who have—or who are at risk for developing— chronic diseases. This approach is built on the philosophy that a strong primary care system offers the most efficient way to interact with most patients most of the time, while recogniz- ing that some patients need additional support and specialty care to achieve the best possible outcomes. Patients are stratified into three levels of care: 1. Primary care with self-care support for the 65 percent to 80 percent of patients whose conditions are generally responsive to lifestyle changes and medications. 2. Assistive care management to address adherence problems, com- plex medication regimens, and comorbidities for the 20 percent to 30 percent of patients whose diseases are not under control through care at level 1. 3. Intensive case management and specialty care for the 1 percent to 5 percent of patients with advanced disease and complex comorbidi- ties or frailty. Level 1 emphasizes a proactive team approach that conserves physi- cian time for face-to-face encounters by enhancing the contributions of

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269 APPENDIX B ancillary staff (medical assistants and also nurses and pharmacists in some locations) to conducting outreach to patients between visits. The team uses a population database and decision support tools built into the EHR to track patients with chronic conditions such as diabetes or heart disease, develop action plans to engage them in self-care, ensure that they are tak- ing appropriate medications, and remind them to get preventive care and other tests when needed. Outreach to patients with chronic conditions typically occurs as follows: The physician reserves a weekly appointment slot to meet with his or her staff and review a computer-generated list of 10 to 20 patients who are not achieving treatment goals. The physician indicates follow-up instructions for each patient, such as increasing medication dosage or ordering a test. The medical assistant or nurse then contacts the patient to relay the physician’s instructions, using prepared scripts to ensure consistent communication. Contact is typically made by telephone but may occur by letter in some cases. At level 2, care managers (specially trained nurses, clinical social work- ers, or pharmacists) support the primary care team to help patients gain control of a chronic condition. Interventions may include providing self- care education, titrating medications according to protocol, and making referrals to educational classes (e.g., for smoking cessation). The goal is to move patients back to level 1 after an intervention period of several months to a year. Successful transitions require that primary care teams be prepared to follow up with patients and prevent them from relapsing. Care managers may be part of the local primary care team or may be centrally located at a medical center, depending on local resources. An example of intensive case management (level 3) is a cardiac reha- bilitation program called Multifit for patients with advanced heart disease, such as those recovering from a heart attack or heart surgery. Nurse case managers provide telephonic education and support for up to 6 months to help patients make lifestyle changes and reduce their risk of future cardiac events. Aided by the EHR and a patient registry, the Colorado region enhanced the program by adding a telephonic cardiac medication management service provided by clinical pharmacy specialists, with ongo- ing follow-up until patients achieve treatment goals and can be transferred to primary care for maintenance. Results for patients participating in the Colorado program included the following: • Cholesterol screening increased from 55 percent to 97 percent of patients, while cholesterol control has almost tripled from 26 per- cent to 73 percent of patients. • Relative risk of death declined by 89 percent among those enrolled in the program within 90 days of a cardiac event, and by 76 per- cent for those with any contact with the program.

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270 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM HIT as an Engine for Continuous Innovation Developing Improved Modes of Care Delivery The 21st Century Care Collaborative is using KP HealthConnect to develop innovations that will transform the ability of primary care teams to improve patient care delivery and member experience while also promoting a sustainable work environment for clinicians and staff. A prototype change package—developed from the experience of several pilot-test sites—is being spread regionally using a flexible approach that lets facilities and teams test elements to determine what works best in their circumstances. Principles and examples include the following: 1. Understand the needs of your population: Design the work and build the care team to meet the needs; for example, maximize team roles and optimize team communication. 2. Develop relationship-based care and demonstrate that we know members; for example, convene member councils, complete after- visit summaries. 3. Provide alternatives to traditional office visits; for example, offer telephone visits and group visits, use secure messaging. 4. Embrace total panel ownership; for example, conduct outreach to patients with chronic conditions, follow up with patients on new medicines. 5. Engage members in collaborative care planning; for example, use goal sheet with diabetic patients, convene chronic care support groups. These changes have synergistic effects. For example, replacing face- to-face visits with telephone visits saves time and increases convenience for members. It also frees time for the care team to conduct proactive panel-management activities, address urgent-care needs, and look for other opportunities to make things easier for patients, such as by calling those on the appointment schedule to resolve problems over the phone. Pilot sites reported improved quality and increased satisfaction for members and staff. Pursuing Advances in Medicine In Northern California, Kaiser Permanente’s Division of Research con- ducts epidemiological and health services research to improve the health and medical care of members and the population at large. A major cur- rent project is assembling one of the world’s largest biobanks of genetic,

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271 APPENDIX B environmental, and health data. The biobank will enable research on the causes of diseases that eventually may lead to advances in diagnosis, treat- ment, and prevention. Almost 400,000 Northern California members have volunteered to participate in the program by completing a health survey and are being asked to contribute saliva samples for DNA analysis. Lessons Learned The Right People at the Table It’s imperative that clinicians play a significant role in the planning, design and implementation of an EHR system. They use the system day in and day out, so they need to be involved in the decision-making process. If not, you end up with just a fancier version of the paper record. In designing HealthConnect, hundreds of stakeholders and IT experts worked together for months to figure out the functions the system needed to best serve its members. Training Is Integral to Success A large portion of costs were attributable to training and workflow re-design. A great deal of time and energy was spent to accommodate the ramping-up process after the system was implemented. Kaiser has con- tinued with the training and exchanges of best practices and believes it must be an ongoing process. Don’t Underestimate the Desire to Do the Right Thing It would be unrealistic to say that every doctor switched over to elec- tronic records without any issue. The transition was much more of a culture shock for doctors who had been using paper records for 30 or 40 years. Some were more resistant to change than others, which can be expected in a project of this size. At the end of the day, though, clinicians understood that what was being done was in the best interest of the patient.

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272 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM THE SMART GRID3 Conception The Smart Grid was mandated at the federal level. Title XII of The Energy Independence and Security Act of 2007 stated that the National Institute for Standards and Technology has “primary responsibility to co- ordinate development of a framework that includes protocols and model standards for information management to achieve interoperability of smart grid devices and system.” Vision As conceived, the Smart Grid will • Enable active participation by consumers • Accommodate all generation and storage options • Enable new products, services, and markets • Provide power equality for the digital economy • Optimize asset utilization and operate efficiently • Anticipate and respond to system disturbances (self-heal) • Operate resiliently against attack and natural disaster Governance At the recommendation of the Federal Energy Regulatory Commission, a profit-neutral organization known as an independent system operator or regional transmission organization will be charged with coordinating and managing the operations of the grid. The scale of these organizations is variable (e.g., local, state, regional). Consumers Energy In response to a request from Consumers Energy’s president and chief executive officer, Dave Joos, a small company team started investigating the smart grid in early 2007. Since then, Consumers Energy has created the Smart Services Learning Center, a smart-grid testing and demonstra- tion facility, to assess vendor products and provide product and integration testing. The company performs product field tests by using strategically deployed off-grid meters that are tied back wirelessly to the center. Consumers Energy’s initial testing and assessment has revealed a clear 3 Prepared by Roundtable staff.

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273 APPENDIX B lack of product standardization and integration throughout the industry. With this in mind, the company believes more standardization must be achieved before beginning a full-scale smart-grid system implementation. Company officers, managers, and directors understand the risks involved with deploying systems too quickly and support efforts to further assess and improve vendor products. Consumers Energy is working with other industry experts to help estab- lish standards and guidelines for an integrated, secure smart-grid systems environment. For example, the company helped create the SAP Lighthouse Council, a group of leading utilities and vendors that collaborate with SAP to develop standardized software and interfaces for smart-grid systems and devices. Employees also are helping ensure that standardized interfaces are built into customer and grid-based devices to allow for easy connectivity with new utility systems and devices. They have been actively involved with other utili- ties, vendors, standards organizations, and regulators to ensure that appro- priate security capabilities are built into the systems, and that systems can be updated easily when new security threats arise. Upgradability, standard interfaces, and vigorous testing are the best methods for minimizing risks, avoiding product obsolescence, and lowering product costs. The Model Fundamentally, the Smart Grid is a long-term, complex systems devel- opment project of nationwide scale and implications. It uses the engineer- ing approach of accommodating a wide variety of legacy nodes that are organic—constantly growing and evolving like a biological system. This continuous evolution is desirable, so that the Smart Grid’s architecture can preserve, and indeed encourage, the capacity of every node to innovate locally and deal with complexity in a way that suits local and grid needs. The Smart Grid development methodology is not based on compre- hensive internal design and operating standards for each node on the grid to follow. There is no need for consensus among the nodes on how they should operate within local boundaries. Instead, the approach accommo- dates highly diverse nodes connecting to the Smart Grid using open data translation protocols that standardize information management, rather than using the internal workings of each node. The grid becomes a com- munications bus to which each node must be able to write, and from which each node must be able to read. This architecture preserves capacities for local operating autonomy and innovation throughout the Smart Grid. It is also manages a standardized communications capacity among complex, and otherwise noninteroperable, legacy nodes on the grid. These features are all characteristics of ultra-large-scale (ULS) software intensive systems.

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274 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM VISA AND THE “CHAORDIC” GOVERNANCE MODEL4 By Chaord, I mean any self-organizing, adaptive, non-linear, complex sys- tem, whether physical, biological, or social, the behavior of which exhibits characteristics of both order and chaos or, loosely translated to business terminology, cooperation and competition.—Dee Hock Background In the 1960s, the nascent credit card industry witnessed rapid growth, quickly outgrowing the governance structure of most companies. Although membership and participation were booming, companies were losing money. As the decade neared a close, a lack of organizational regulation and control left the industry with estimated losses in the tens of millions. Foundations of a New Model In an attempt to regain control of the industry, Bank of America formed a small committee to devise solutions to operational problems. In his role as chair of this committee, Dee Hock began to construct a new governance model. According to Hock, what emerged from the meeting was a set of several principles, framed as “what if” questions: • What if the organization were cooperatively and equitably owned, with all relevant and affected parties eligible to participate in func- tions, governance and ownership? • What if power and function were distributive, with no power vested in or function performed by any part that could reasonably be exercised by any more peripheral part? • What if it were self-organizing, with participants having the right to self-organize at any time, for any reason, at any scale, with ir- revocable rights of participation in governance at any greater scale? 4 Prepared by Roundtable Staff using the following sources: Fowler, J. Gone chaordic: Dee Hock, the mastermind behind VISA, has some ideas about reorganizing health care. Health Forum Journal. Hock, D. W. 1995. The chaordic organization: Out of control and into order. World Business Academy Perspectives 9(1). Waldrop, M. M. 1996. Dee Hock on organizations. Fast Company. http://www.fastcompany. com/magazine/05/dee3.html. Waldrop, M. M. 1996. The Trillion-Dollar Vision of Dee Hock. Fast Company. http://www. fastcompany.com/magazine/ 05/deehock.html?page=0%2C0.

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275 APPENDIX B • What if governance were distributive, with no individual, institu- tion, or combination of either or both, particularly management, able to dominate deliberations or control decisions at any scale? • What if it could seamlessly blend cooperating and competing, with all parts free to compete in unique, independent ways, yet could yield self-interest and cooperate when necessary to the inseparable good of the whole? • What if it could be infinitely malleable, yet extremely durable, with all parts capable of constant, self-generated, modification without sacrificing its essential nature, thus releasing human ingenuity and spirit? VISA—A Novel, Chaordic Organization As envisioned by Hock, the governance model that emerged from that meeting, and would become the structure behind VISA, defied previously well-established tenets of corporate organization. VISA was a nonstock, for-profit membership corporation with ownership in the form of nontrans- ferable rights of participation. VISA was highly decentralized and highly collaborative and functioned, as Hock believed, as “an enabling organiza- tion” above all else. Similar to a Jeffersonian governmental structure, every- thing possible (authority, initiative, decision making, wealth) was relegated to the periphery, with only standards and the most large-scale operational issues remaining under centralized control. The center-and-periphery model posed a logical solution to a fundamental problem within the credit card industry: member financial institutions were all competitors (issuing their own cards) but, in order to have a sustainable system, needed to all cooper- ate (regardless of which bank issues cards, all VISA cards must be accepted by all merchants). According to Hock, the success of this business model is best demon- strated by the fact that, although VISA is an enormous corporation, few know of its organizational structure. However, at the same time, the core of the enterprise has no knowledge of or authority over a vast number of the constituent parts. No part knows the whole, the whole does not know all the parts and none has any need to. The entirety is largely self-regulating. Core Tenets of Chaordic Organizations Hock has long insisted that the VISA model cannot be transposed suc- cessfully onto any other industry. It is the notion of a chaordic governance model, not anything specific to VISA’s history, that can be used across institutions. However, inherent in toeing the line between chaos and order, designing and implementing such a governance model is an organic and dy-

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276 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM namic process unique to the institution attempting it. Although the product will be drastically different in each case, there are certain core tenets of the chaordic model. Some examples include • Maximize human ingenuity. Hock argues that the most abundant, least expensive, most underutilized, and frequently abused resource in the world was human ingenuity; the source of that abuse was archaic, Industrial Age institutions and the management practices they spawned. • Organizations must have clarity of a shared purpose, common principles, and strength of belief. According to Hock, organizations are merely conceptual embodiments of a very old, very basic idea— the idea of community. An organization’s success has enormously more to do with clarity of a shared purpose, common principles and strength of belief in them than to assets, expertise, operating ability, or management competence. • Push all possible operations to the periphery. No function should be performed by any part of the whole that could reasonably be done by any more peripheral part, and no power vested in any part that might reasonably be exercised by any lesser part. • Foster and tolerate evolution. The organization must be adaptable and responsive to changing conditions, while preserving overall cohesion and unity of purpose. The governing structure must not be a chain of command, but rather a framework for dialogue, de- liberation, and coordination among equals.