HIE Trust Framework’s Essential Components: NHIN Workgroup

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HIE Trust Framework: Essential Components for Trust;
NHIN Workgroup of HIT Policy Committee
Presentation with slides were made at Health IT Policy Committee on April 21, 2010 by David Lansky, Chair of NHIN Workgroup and Farzad Mostashari of ONC. The slides have been converted to html for your viewing.
PDF Version

Discussion Topics
–Recommendations for a national-level  HIE Trust Framework
–HIE trust framework is applied to a directed push model
          –Implications of third parties supporting aspects of the HIE trust framework

NHIN Workgroup Recommendation (Feb. 2010)
Role of Government
–Establish and maintain a framework of trust, including ensuring adequate privacy and security protections to enable electronic health information exchange.
–Create structures/incentives to enable information exchange where trust or necessary standards / services do not exist.
–Limit intervention where information exchange with providers currently exists – to the extent possible.
–Create incentives to improve interoperability, privacy and security of information exchange.
–Support real-world testing and validation of the services and specifications to verify scalability on a nationwide basis.

HIE Trust Framework: Findings
–There is a need for a national-level trust framework to promote the electronic exchange of health information:
          –Provides a tool for understanding how trust may be implemented across a broad range of uses and scenarios
          –Addresses need for adequate privacy and security protections
          –Articulates the common elements required for exchange partners to have confidence in health information exchange (HIE)
                   •Recognizes that implementation of the framework will vary depending upon  various factors (e.g., exchange partners, information, purpose, etc.)
          –Supports interoperability from a policy perspective –Considers lessons learned from existing HIE activities

HIE Trust Framework: Recommendation
–Adopt an overarching trust framework at the national level to enable health information exchange that includes these essential elements:
          –Agreed Upon Business, Policy and Legal Requirements / Expectations
          –Transparent Oversight –Accountability and Enforcement
          –Identity and Authentication –Minimum Technical Requirements
–All five components needed to support trust, but individually may not be sufficient.

HIE Trust Framework: 
Essential Components for Trust
•Agreed Upon Business, Policy and Legal Requirements: All participants will abide by an agreed upon a set of rules, including compliance with applicable law, and act in a way that protects the privacy and security of the information.  
•Transparent Oversight: Oversight of the exchange activities to assure compliance. Oversight should be as transparent as possible.
•Accountability and Enforcement: Each participant must accept responsibility for its exchange activities and answer for adverse consequences.
•Validation of Exchange Partners & Identities:  All participants need to be confident they are exchanging information with whom they intend and that this is verified as part of the information exchange activities.
•Technical Requirements: All participants agree to comply with some minimum technical requirements necessary for the exchange to occur reliably and securely. 

1. Agreed Upon Business, Policy and Legal Requirements
Agreed upon and mutually understood set of expectations, obligations, policies and rules around how partners will use, protect and disclose health information in general and their exchange-related activities specifically (not necessarily top-down regulation). 
–Built upon existing applicable law, including HIPAA and  federal and state law.
–Requires participants to act in a way that protects privacy and security of the information.
–Varies depending upon context – e.g., type of exchange, parties involved (including relationship of partners), purposes for which data are exchanged (including secondary and future use), etc. 

Value as a Factor for Reinforcing Trust
Compliance with the trust framework is necessary in order to realize value of exchange 
          –Value of exchange creates incentive to participate in information sharing; –Obligation  to abide by and continue complying with trust requirements in order to continue realizing that value;
          –Knowing that one’s exchange partners see value in the exchange provides some assurance that they will continue to comply;
         –Other elements address specific aspects to promote trust.

2. Transparency and Oversight
“Oversight” is intended to mean management, maintenance, supervision, and monitoring of the trust relationship and exchange activities.

There should be as much transparency as possible in:
     –The oversight mechanisms employed to protect the information; and
     –The oversight process and results, including findings and consequences.  (Some oversight, e.g., governmental oversight, may not be entirely transparent.)

–The nature of oversight and the mechanisms used will depend upon exchange model, the parties involved, and the needs the exchange partners identify.
–Oversight will operate at multiple levels (e.g., parties to the exchange, individual subject of the information, third parties, government, etc.)
–Oversight should make that even with the trust framework and mechanisms in place, that there is no guarantee of privacy and security.

3. Enforcement and Accountability
Each exchange partner is accountable for its exchange activities and must be prepared to answer at multiple levels. For example:
         –Individual subjects of the exchanged information;
         –Other participants in the exchange; 
          –Third parties providing enabling functions; –Certifiers / accrediting bodies; –Governmental entities. 

–Methods for confirming, detecting and enforcing compliance may vary (e.g., self-certification, self-attestation, trust enabling organization, etc.)
–Specific mechanisms and business rules may vary based upon context.
–May include enforcement of penalties for failing to uphold commitments to conduct activities as a trusted exchange partner and, if appropriate, redress for those harmed by such failure. 

Common desire to avoid these consequences gives each exchange partner some comfort that all other exchange partners will uphold their commitments.

4. Identity and Authentication
–Exchange partners will not exchange information with just anyone. Each has to be confident they are exchanging information with whom they intend to exchange information and that the other partner is trustworthy.
–Each exchange partner therefore validates (and maintains an audit log of) the identity of those with whom it exchanges information.
==Validation of parties to the exchange can occur in a number of ways (e.g., using identity proofing and digital credentials to validate authorized members of a network).

5. Minimum Technical Requirements
In all exchanges, partners have to adhere to technical standards to support the privacy and security requirements of the trust framework.
–Technical requirements for the exchange could include measures designed to ensure that data received have been unaltered during transit.
–Non-compliance with technical requirements for secure transport will prevent an exchange from occurring, but may not always be visible. 

Trust Enabling Functions Applied to Directed Push of Information Scenario
Agreed upon business, policy and legal requirements
–Based upon applicable law and expectation that privacy and security of the information will be protected
–Additional policies relating to use of data by enabling organizations (e.g., metadata or data content)
–Informal social contract if EHR-to-EHR without use of a third party;
–Formal agreements may be required if there is a third party involved in supporting aspects of trust framework, such as:
     •Between a healthcare provider organization and a third party that performs or supports part of the trust framework for that provider (e.g., secure routing, identity services) or provider directory services.
     •Between a healthcare provider organization and a third party that offers other HIE services, such as secure messaging, translation, data aggregation, etc.;
     •Between healthcare provider organization and its end users.

Trust Enabling Functions – Applied to Directed Push of Information
Transparency and Oversight
–Patient and exchange partners oversee and monitor to ensure exchange occurs.  –Governmental oversight of compliance with laws (e.g., HIPAA). 
–There is a governmental role regarding the performance of identity assurance and routing functions.
–That oversight must include transparency to foster accountability of the enabling functions.
–A third party that provides trust enabling functions may also play a role in oversight.

Enforcement and Accountability
–Exchange partners are accountable to each other, patient and governmental agencies.
–Third parties that support  trust enabling functions should also be accountable.
–One consequence for failing to uphold commitments to comply with the minimum requirements and code of conduct is termination of the exchange relationship between the parties.
–Other consequences could include legal implications (e.g., if breach of formal contract), liability, redress for harm, etc.)

Identity and Authentication
–Identities of exchange partners and/or users validated by provider organization or third party identity service provider; other participants rely upon this.

Minimum Technical Requirements
–Meaningful use certification criteria (e.g., secure transport, etc.)
–The ability to look up and locate a provider’s electronic address
–The ability to securely route information to the provider’s electronic address, which could occur:
     •EHR to EHR or Lab to HER
     •EHR to PHR
     •EHR to EHR using a third party’s routing services;
     •EHR to EHR using third party services (e.g. registry services, provider directories, identity services, etc.);
     •EHR to EHR using other HIE services (e.g., HIOs, PHRs, eprescribing networks, secure messaging, EHR-specific networks, etc.)

Patient-centered approach to Health IT Safety

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Patient-centered approach to Health IT Safety
Recommendations of Adoption Certification Workgroup
Here’s the text of a draft recommendation to be presented and discussed at the Health IT Policy Committee on April 21, 2010.
Meeting materials on ONC site

DRAFT DOCUMENT –
SUBJECT TO HEALTH IT POLICY COMMITTEE REVIEW AND APPROVAL –
PDF VERSION

April 21, 2010

Dear Dr. Blumenthal:

The HIT Policy Committee (Committee) gave the following broad charge to the Adoption-Certification Workgroup:

Broad Charge to the Workgroup: To make recommendations to the HIT Policy Committee on issues related to the certification and adoption of a certified EHR for every American by 2014, including issues related to workforce, training, etc.

This letter provides recommendations to the Department of Health and Human Services (HHS) on the topic of patient safety.

BACKGROUND AND DISCUSSION

On February 25, 2010, the Adoption-Certification Workgroup (Workgroup) held a hearing on the topic of patient safety related to the use of electronic health records. A summary of the hearing is attached. After the hearing was held, the Workgroup conducted several public phone conference calls during which possible approaches to this vitally important topic were discussed. Preliminary findings were discussed with the HIT Policy Committee during its meeting on March 19, 2010. Based upon the feedback that we received during these meetings and from the public, we are making the following patient safety recommendations, based upon the following goal:

Establish a patient-centered approach to HIT safety that is consistent with the National Coordinator’s vision of a learning health and healthcare system. To achieve this goal, a culture of improvement needs to be created by each healthcare entity.

HIT POLICY COMMITTEE RECOMMENDATIONS AND COMMENTS: NATIONAL OVERSIGHT PROCESS AND INFORMATION SYSTEMS

In order to create the conditions that enhance the ability to prevent unsafe conditions that could lead to injuries, information is needed on hazards and “near-misses.”

In order to create the conditions that enhance the ability to prevent unsafe conditions that could lead to injuries, information is needed on hazards and “near-misses.”

Recommendation 1.0 – A national, transparent oversight process and information system is proposed, similar to a Patient Safety Organization (PSO), with the following components:

  Confidential reporting with liability protection (e.g.,. whistle-blower protection, confidential disclosure of adverse events)

  Ability to investigate serious incidents

  Provision of standardized data reporting formats that facilitate analysis and evaluation

  Receive reports from patients, clinicians, vendors, and healthcare organizations

  A reporting process to cover multiple factors including usability, processes, and training

  Receive reports about all health information technology (HIT) systems

  Receive reports from all Software Sources (e.g., vendors, self-developed, and open source)

  Ability to disseminate information about reported hazards

While this recommendation appears to be necessary, it might not represent a complete response to all HIT patient safety concerns. Additional research is needed.

Recommendation 1.1 - We recommend that the Office of the National Coordinator (ONC) commission a formal study to thoroughly evaluate HIT patient safety concerns, and to recommend additional actions and strategies to address those concerns.

FACILITATE AND ENCOURAGE REPORTING

We learned that most unsafe conditions are not the result of a single software error. Instead, multiple factors are involved, including challenges with usability, processes, and interoperability. Healthcare organizations and clinicians represent a primary source of information about unsafe conditions. In order to encourage healthcare organizations and clinicians to report unsafe conditions, we make the following recommendations.

Recommendation 2.0 – Stage 2 of Meaningful Use should include a requirement that EPs and hospitals report HIT-related patient safety issues to an organization authorized by ONC to receive HIT-related safety reports (“HIT safety organization”). Copies of those reports should be sent to any vendors that might be involved.

Recommendation 2.1 – Certification criteria for EHRs should include functionality that makes it easier for clinician-users to immediately report any problems/concerns with information that appears on screens (a “feedback button”) to appropriate staff who can either make modifications themselves or escalate the problem to those who can. This feedback button could also be used by clinician-users to request corrections to data.

Recommendation 2.2 – The Regional Extension Centers should provide HIT-related patient safety reporting training.

VENDOR PATIENT SAFETY ALERTS

The certification process can be used to ensure that vendors provide safety alerts to their customers, and it can also be used to improve patient safety.

Recommendation 3.0 – We recommend that the Stage 2 EHR certification criteria should include requirements that vendors maintain records on all patient safety concerns reported by their customers, and that vendors have established processes to promptly provide all impacted customers with safety alerts.

PATIENT ENGAGEMENT

Patient Engagement plays a major role in identifying errors and preventing problems. For example, in ambulatory settings, in nearly every encounter when it is possible for patients to observe and discuss information as it is entered during the health care encounter, potential errors can be avoided. Through a personal health record (PHR) or patient portal, patients obtain the ability to review some of the data in their EHR, and, as a result, PHRs and/or patient portals should continue to be encouraged. Access by family members to inpatient medication lists should also be encouraged (assuming appropriate authorization from the patient). Mechanisms that make it easier for patients to report inaccurate or questionable data need to be encouraged as ―best practices.‖ Examples include (a) the use of a ―feedback button‖ that makes it easy for a patient to communicate with and receive feedback about system problems, and (b) a secure communication link, perhaps through a PHR, that permits patients to link back to the provider to report data corrections and omissions.

IMPLEMENTATION, EDUCATION, AND TRAINING

The implementation, education, and training processes can impact patient safety conditions. Training programs should include information about the value of reporting patient safety incidents and unsafe conditions in the context of broader educational efforts to create and continuously enhance cultures of patient safety.

INTEROPERABILITY

Interoperability problems are a significant source of patient safety concerns. As a result, ONC’s interoperability efforts continue to be extremely important

Recommendation 4.0 – The HIT Standards Committee should consider the concept of “traceability” of interface transactions. “Traceability” refers to the ability to trace and analyze the source of problems. The HIT Standards Committee is asked to consider techniques like requiring the use of audit trails or “logs” of interface transactions.

BEST SAFETY PRACTICES

Recommendation 5.0 - We recommend that ONC work with the Regional Extension Centers (RECs) and with organizations such as the American Medical Informatics Association (AMIA) to create a set of best safety practices for selecting, installing, using, and maintaining HIT, and disseminate those best practices to providers. Tools, such as Geisinger/Jim Walker’s Hazard Evaluation tool and Dave Classen’s flight simulator should be explored as possible resources for providers.

ACCREDITATION

Accreditation organizations such as The Joint Commission can play an important role in assuring HIT patient safety.

Recommendation 6.0 – ONC should discuss HIT patient safety concepts with these organizations to determine, for example, if they are examining whether large institutions have a patient safety review committee, and whether processes are in place that encourage reporting of problems.

TIMING OF STAGE 2 AND STAGE 3
The time period between the publication of certification criteria and the beginning of the eligibility period is a safety concern for both of the next two stages. Any software changes or updates must be carefully tested by each healthcare organization that receives those updates.

Recommendation 7.0 – We recommend that, for each stage, certification criteria should be finalized at least 18 months prior to the beginning of the eligibility period.

With this proposed schedule, a vendor could have 12 months to develop, test, certify, and distribute their software, and then customers could have 6 months to test, train and implement changes prior to the beginning of the eligibility period. For example, this schedule would require that Stage 2 certification criteria be finalized by April 1, 2011, which would allow vendors to complete their programming, testing, certification, and distribution work by April 1, 2012, and existing customers to train, test and implement by October 1, 2012. For vendors with a large number of customers, the six month window is probably difficult, and an even longer period might be requested. In this example, in order to finalize the certification criteria for Stage 2 by April 1, 2011, the initial publication needs to occur by December 31, 2010.

FOOD AND DRUG ADMINISTRATION
A number of concerns were expressed about the potential for increased Food and Drug Administration (FDA) regulation of EHR systems. These concerns include:

a. The FDA focuses on problems caused by individual ―devices.‖ As a result, it does not seem to cover situations where problems occur even though the software is operating correctly. This is only one example of a situation that arises because HIT is embedded in a sociotechnical system that includes a complex mix of people, technology, work processes, and factors outside the organization that influence it.

b. The FDA reporting system focuses on serious injuries and death caused by individual devices. That reporting process might not cover many unsafe conditions and hazards, such as incompatible work-processes in which no actual injuries occur, that might be another result of sociotechnical factors beyond the technology.

c. The FDA’s Quality Systems Regulation (QSR) process is inconsistent with the incremental nature of HIT development, and, as a result, could harm innovation and increase vendor and product costs. By hampering and slowing the ability of vendors to continuously improve systems, thus making them safer, such a process could actually work against the safety efforts we are proposing.

d. The increased costs of FDA class II regulation could become a barrier to entry for small vendors.

While we have concerns, we have also seen that the FDA has valuable experience that could help the ONC accomplish its goals. Two possible ways that the ONC and the FDA could collaborate are:

1. Collaborate on certification criteria that improve patient safety.

2. Focus on selected HIT areas that are creating safety risks for EHR implementations. For example, retail pharmacies create safety problems because they do not process electronic order cancellations, which can result in over-medication of patients. Additionally, most retail pharmacies are not providing compliance data. The FDA could be a valuable ally to address this type of patient safety issue with non-certified software systems that connect to the EMR.

Recommendation 8.0 – We recommend that the ONC work with the FDA and representatives of patient, clinician, vendor, and healthcare organizations to determine the role that the FDA should play to improve the safe use of Certified EHR Technology.

FINAL OBSERVATION
The workgroup did not hear any testimony that indicated that EHR systems and CPOE systems should not be implemented. We detected, however, frustration that these systems are not reaching their full potential. We also clearly heard concerns that these systems need to be properly and safely implemented. In the public comments, we were also reminded of the 1999 Institute of Medicine report, which indicated that over 90,000 lives could be saved each year through computerized ordering. As a result, we believe that the biggest risk to patient safety would be to either avoid or delay the proper implementation of EHR and CPOE systems.

Recommendation 9.0 – We recommend that ONC continue its efforts to encourage implementation of EHR systems.

Sincerely yours,
Paul Egerman  and Marc Probst
Co-Chairs  
Adoption Certification Workgroup

Building Sustainable HIE Capacity: Addressing Key Issues in State HIE Leadership Webinar Series

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Building Sustainable HIE Capacity: Addressing Key Issues
Part of the 2010 State HIE Leadership Forum Webinar Series
Presented by the State Level HIE Consensus Project Under the Auspices of the ONC State HIE Program on April 15, 2010.  Presentation includes examples of four revenue mechanisms with advantages and drawbacks, plus more specifics on Vermont’s experience.

Link to Webinar series presentations
http://slhie.org/forum-resources/presentations/

Building Sustainable HIE Capacity Presenatation (pdf)

Four Revenue Mechanisms

1. Subscription Fees
Description
–Participants pay fees based on a schedule (e.g., annual or monthly). Different variations are possible, including a tiered fee schedule which recognizes differing levels of participation, organization type, or organization size.

Example
–HealthBridge, acquires approximately 85 percent of its operational revenues from subscription fees charged to healthsystems using the exchange.

Advantages
–Participants can better predict their level of payment
–Statewide HIE effort can better predict its level of revenue and long term implementation strategy
–Provides a transparent and straightforward pricing structure
–Few disincentives to participate once membership fee is accepted and paid

Drawbacks
–If the number of participating organizations is limited, fees would have to be substantial to generate significant revenue
–Other than attracting new members, fees can likely increase no more than annually
–Significant lag may develop from time when expenses incurred to opportunity to raise fees and generate needed revenue
–May be less desirable in some situations–especially for those constituencies who will be both data suppliers as well as data consumers of the exchange.

2. Transaction Fees
Description
–Participants pay fees on type of service or data requested. This may include a tiered scale with volume discounts – lower fee per message delivered for higher volumes. A nominal, onetime start-up fee may also be charged.

Example
–Micro-fee for every patient lookup transaction. Typically between $0.25 or $2.00.

Advantages
–Participants pay in direct proportion to their use of the HIE
–Has the potential to generate significant revenues as volume of HIE and associated costs rise over time

Drawbacks
–Transaction fees may discourage participants from using the HIE
–May be hard for organizations to predict their evel of use and therefore budget for fees
–Challenging for Statewide HIE effort to predict its evenue
–Challenging to substantiate fee structure during stat-up phase in the absence of a “track record” of performance
–Administrative requirements for billing and ayment may be overly complex.
–HIE costs may become “lost” if embedded within larger set of charges for a hospital stay or outpatient encounter.

3.  All Payer Assessments
Description
–Surcharge on healthcare claims

Example
–Since Oct. 1, 2008, each health insurer operating in Vermont paid a quarterly fee into a fund. Insurers choose between paying 0.199% of all healthcare claims paid for their Vermont members in the previous quarter, or a fee based on the insurer’s proportion of overall claims in the past year.

Advantages
–Has the potential to generate significant revenues
–Statewide HIE effort can reasonably predict its level of revenue from this source and long term implementation strategy
–Charge being borne by a broadbased constituency – all recipients of healthcare services
–Has the potential to generate significant revenues
–Statewide HIE effort can reasonably predict its level of revenue from this source and long term implementation strategy
–Charge being borne by a broadbased constituency – all recipients of healthcare services

Drawbacks
–Depending on services offered, value to payers varies significantly
–Legislative and/or economic climate may or may not support this option
–Payers may pass the fee on to patients through increased premiums if assessment is added to claims
–ERISA plans may fall out of the State’s jurisdiction

4. Performance-based Incentives
Description
–Incentives paid by insurers to physicians and health systems for achieving certain healthcare-related quality measures or milestones that depend on the use of HIE.

Example
Pay-for-performance programs and Medicare and Medicaid MU incentives.

Advantages
–Focuses on performance over process

Drawbacks
–Can be more complex to administer than alternative mechanisms

Bringing it All Together
State Experiences Developing Financing Approaches
Statewide HIE: Vermont Information Technology Leaders

HIE Services:
• Laboratory connectivity service
• Chronic disease data service
• Medication history data service
• Radiology connectivity service (Planned)
• Continuity of Care Document exchange service (Planned)

Financing Strategies:
• Began with support from a legislative appropriation and a commitment by medication history client to pay transactional fees
• The revenue model evolved when the Vermont Department of Health agreed to pay a monthly subscription fee to support the development of chronic disease data services to support its Blueprint for Health initiative
• With support from the legislature and administration the Health IT Fund was created using a 0.199 percent fee on all medical claims. When estimating the need for funding, VITL analyzed cost of operating the HIE, building /maintaining interfaces, and providing EHR implementation grants to 122 independent primary care practices. This funding greatly reduced ongoing legislative appropriations for VITL.
• Additionally, VITL received additional grant funding for HISPC and other initiatives.

Experiences from others
States with Business Plans for Statewide HIE
–Colorado, Delaware, Maine, North Carolina, Rhode Island, Utah

States with ONC approved Operational Plans
–New Mexico

States just getting started
–Others

Patient/Consumer Engagement in Meaningful Use: Apr 20 Hearing

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Patient/Consumer Engagement in Meaningful Use:
April 20, 2010 Hearing; Access via Web, Phone, or iPhone 
Meaningful Use Workgroup, HIT Policy Committee
Available Testimony Added
Washington, DC
Tuesday, April 20, 2010, 9 a.m. to 3:30 p.m./Eastern Time

AGENDA (pdf version)
9:00 a.m. Call to Order/Roll Call – Judy Sparrow, Office of the National Coordinator
9:05 a.m. Meeting Objectives and Outcomes: Consumer Engagement
     – Paul Tang, Chair, and George Hripcsak, Co-Chair
9:15 a.m. Panel 1: Meaningful Use of HIT in the Real Lives of Patients & Families
     Scott Mackie, Health & Wellness, IDEO, Inc.
     Eric Dishman, Director, Health Innovation & Policy, Intel Corp.
     M. Chris Gibbons, Johns Hopkins University Urban Health Institute
     Neil Calman, MD, Institute for Family Health
     Regina Holliday, patient voice
10:45 a.m. Panel 2: Incorporating Patient-Generated Data in Meaningful Use of HIT
     James Ralston, Group Health Research Institute
     James Weinstein, Dartmouth Institute for Health Policy & Clinical Practice
     Patti Brennan, University of Wisconsin, Project Health Design
     Carol Raphael, Visiting Nurse Service, NY
     Dave DeBronkart, ePatient Dave
     David Whitlinger, NY eHealth Collaborative
     Hank Fanberg, Christus Health
12:15 p.m. LUNCH BREAK
1:15 p.m. Panel 3: Policy Challenges & Infrastructure Requirements to Facilitate Patient/Consumers’ Meaningful Use of HIT
     Joy Pritts, Chief Privacy Officer, ONC
     Carl Dvorak, Epic Corp., (Provider/Vendor Perspective)
     Cris Ross, MinuteClinic
2:45 p.m. Summary Comments from the Workgroup
3:15 p.m. Public Comments
3:30 p.m. Adjourn

Available Testimony as of April 19, 2010
–Dave DeBronkart, ePatient Dave – Testimony [PDF - 384 KB]
–Patti Brennan, University of Wisconsin, Project Health Design – Testimony [PDF - 628 KB] 
           Brennan, Health in Everyday Living – Article [PDF - 636 KB]
–James Ralston, Group Health Research Institute – Testimony [PDF - 58 KB]
–Carol Raphael, Visiting Nurse Service, NY [PDF - 567 KB]
–Carl Dvorak, Epic Corporation – Testimony [PDF - 357 KB]
–Hank Fanberg, Christus Health – Testimony [PDF - 614 KB]

To participate via
Webconference:
At least 10 minutes prior to the meeting start time, please go to: http://altarum.na3.acrobat.com/mu Exit Disclaimer

  • (If for any reason the link does not work, simply copy and paste the URL into your browser’s address bar)
  • Select “enter as a guest” 
  • Type your first and last name into the field 
  • Click “enter room” 
  • Test Your System:
    • You will need to have an up-to-date version of Flash Player to view the webconference.  Please test your system prior to the meeting by visiting http://altarum.na3.acrobat.com/common/help/en/support/meeting_test.htm 
    • When running this system test, you do not need to install the Adobe Connect Add-in (step 4 of the test), as that is not relevant to this meeting.
* Please note:  Space in the Web conference is limited.  If for any reason you are unable to log in, you can still dial in via phone to listen to the audio (numbers below). 

Audio:

  • You may listen in via computer or telephone.
    • US toll free:   1-877-705-2976
    • International Direct:  1-201-689-8798

iPhone:

  • You can now watch & listen via your iPhone or iPod Touch (requires Wi-Fi). Here is how:
    • You must acquire the Connect Pro App for the iPhone/IPod Touch
      • On a computer – iTunes> Applications folder
      • On your mobile device – App Store
    • Search for the “Adobe Connect Pro” App
    • Follow the App Store steps to download the application
    • Once you have the app installed on your mobile device, you can simply follow the link & instructions above for participating in the Web conference.

See previous post on “Creating a Vision for Engaging Patients and Families Thru Meaningful Use of Health IT” on e-Healthcare Marketing.

Creating a Vision for Engaging Patients & Families Thru Meaningful Use of Health IT: ONC

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Creating a Vision for Engaging Patients and Families Through the Meaningful Use of Health IT;  April 20 FACA Meeting Set
Wednesday, April 14th, 2010 | Posted by: Joshua Seidman PhD on ONC’s Health IT Buzz Blog and reposted below.

“The meaningful use of patient-facing e-health applications has great potential to improve the quality and efficiency of health and health care. Particularly for people with chronic conditions, research demonstrates that patient activation, chronic care self-management, and shared decision making with their clinicians can have a substantial impact on effectively managing their health.

“The California HealthCare Foundation released new consumer survey data this week which confirms and complements a variety of other research findings. Americans who have electronic access to personal health information know more about their health, ask more questions of their clinicians, and take better care of themselves.

“That’s part of why the Health Information Technology Policy Committee (HITPC) that advises ONC recommended patient/family engagement as one of the five health outcome priorities for meaningful use (MU) of EHRs. And CMS included several relevant objectives in the proposed MU rule it released in January (comments from more than 2,000 organizations and individuals are currently being reviewed by CMS and ONC):

  • Consumers’ timely copy of, and access to, electronic records
  • After-care summary for each outpatient encounter
  • Discharge summary for each hospital stay
  • Patient reminders for preventive & follow-up care”

“The HITPC’s MU Workgroup will be holding a series of public hearings over the next several months to inform its recommendations for Stages 2 and 3 MU definitions. The first of these hearings focuses specifically on the patient/family engagement domain and will be held April 20.

“In addition to the formal hearing, ONC and the MU Workgroup strongly encourage input from the public on this blog regarding the evolution of MU objectives to drive better patient and family engagement. In the coming days, some of the panelists who will testify on April 20 will post blog entries on this site as well.

“We really want to know more about the meaningful use of HIT in the real lives of patients and families. We will explore how patient-generated data can be incorporated into the meaningful use of EHRs. We also need to address the policy challenges and infrastructure required to support patients’ and families’ meaningful use of HIT. This information will help us to develop a long-term framework for the evolution of HIT applications to facilitate patient and family engagement.

“Your input on the same questions we’ve asked the panelists to answer would be most helpful to our efforts, although all comments are welcome. The full list of questions follows.

“Panel 1:  Meaningful Use of HIT in the Real Lives of Patients & Families
a. What are consumers’ health information needs in the context of their real lives?
b. How do results of ethnographic studies of individuals with chronic health conditions inform our understanding of how HIT can improve their use of health information and connectivity with their providers to improve their health?
c. What is the evidence base for patient benefit from their direct use of PHRs and other HIT that interacts with EHRs?
d. What is the role of mobile applications in improving health of individuals?  Is there a specific role for underserved populations?
e. How can we use HIT to make information and knowledge actionable for patients?
f. How does HIT enhance collaboration between patients and their providers and change how the patient’s health is managed?”

“Panel 2:  Incorporating Patient-Generated Data in Meaningful Use of HIT
a. What is the role of patient-generated data in improving health of individuals?  What is the evidence?
b. How can patient-reported data be integrated into EHRs and the clinicians’ workflow to improve care management?
c. How can future conceptions of personal health information platforms and information tools facilitate patient-centered care, including transparency, coordinated care, patient activation, while protecting patient privacy?
d. What is the role of the patient in ensuring data in EHRs is accurate?
e. What are your recommendations for meaningful use criteria for 2013 and 2015 that are achievable by a broad spectrum of providers?”

“Panel 3:  Policy Challenges & Infrastructure Requirements to Facilitate Patient/Consumers’ Meaningful Use of HIT
a. What is required for vendors to be able to export data from EHRs in such a way that consumers and patients can use the data in meaningfully?
b. What is the role of providers in making data available to patients in a meaningful way?
c. What are the meaningful uses of that data once exported?  What evidence of measureable benefits exist?
d. What are the privacy and trust issues that might affect this from happening?”

–Joshua Seidman PhD, Acting Director
Meaningful Use in the Office of Provider Adoption Support
Office of National Coordinator for Health IT

Challenges/Barriers to Clinical Decision Support (CDS) Implementation

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AHRQ Releases Report on “Challenges to Clinical Decision Support (CDS) Design and Implementation”
“A new report” produced for AHRQ  National Research Center for Health IT dated March 2010 and released on April 14, 2010, ”examines the challenges and barriers to implementing clinical decision support (CDS) and found workflow, design and clinician’s level of support are just some of the issues that can affect successful CDS implementation. Challenges and Barriers to Clinical Decision Support (CDS) Implementation (PDF, 254 Kb) describes the challenges and barriers that AHRQ contractors encountered as part of their CDS demonstration project. These challenges and barriers can be successfully addressed by employing several key strategies, which include utilizing standard data exchange formats, providing clinicians with appropriate training, and modifying CDS to address clinicians’ needs.”  Report authors are June Eichner, M.S. and Maya Das, M.D., J.D. of NORC at the University of Chicago.

The following are excerpts from the report Introduction, Lessons Learned, and Project Teams.
I. INTRODUCTION
Overview of Clinical Decision Support
“To improve the quality of medical care in the United States, efforts are being made to increase the practice of evidence-based medicine through the use of clinical decision support (CDS) systems. CDS provides clinicians, patients, or caregivers with clinical knowledge and patient-specific information to help them make decisions that enhance patient care. The patient’s information is matched to a clinical knowledge base, and patient-specific assessments or recommendations are then communicated effectively at appropriate times during patient care. Some CDS interventions include forms and templates for entering and documenting patient information, and alerts, reminders, and order sets for providing suggestions and other support. Although CDS interventions can be designed to be used by clinicians, patients, and informal caregivers, this report focuses on the use of CDS interventions by clinicians to improve their clinical decisionmaking process. In addition, while CDS interventions can be both paper and computer based, their application in the following projects is limited to electronic CDS because of its greater capability for decision support.

“The use of CDS systems offers many potential benefits. Importantly, CDS interventions can increase adherence to evidence-based medical knowledge and can reduce unnecessary variation in clinical practice. The process for development and implementation of CDS systems can establish a standard knowledge structure that aligns with written evidence-based guidelines published by medical specialty societies or Federal task forces, such as the U.S. Preventive Services Task Force (USPSTF). CDS systems can also assist with information management to support clinicians’ decisionmaking abilities, reduce their mental workload, and improve clinical workflows.3 When well designed and implemented, CDS systems have the potential to improve health care quality, and also to increase efficiency and reduce health care costs.

“Despite the promise of CDS systems, numerous barriers to their development and implementation exist. To date, the medical knowledge base is incomplete, in part because of insufficient clinical evidence. Moreover, methodologies are still being designed to convert the knowledge base into computable code, and interventions for conveying the knowledge to clinicians in a way they can easily use it in practice are in the early stages of development. Low clinician demand for CDS is another barrier to broader CDS system adoption. Clinicians’ lack of motivation to use CDS appears to be related to usability issues with the CDS intervention (e.g., speed, ease of use), its lack of integration into the clinical workflow, concerns about autonomy, and the legal and ethical ramifications of adhering to or overriding recommendations made by the CDS system. In addition, in many cases, acceptance and use of CDS systems are tied to the adoption of electronic medical records (EMRs), because EMRs can include CDS applications as part of computerized provider order entry (CPOE) and electronic prescribing (eRx) systems. This is evidenced by the results of the 2008 National Ambulatory Medical Care Survey, which show that only 38 percent of physicians used an EMR, and only 4 percent used an EMR with CDS system capabilities.

“Recent Federal and payer initiatives are providing support for EMR and CDS adoption. For example, the Agency for Healthcare Research and Quality (AHRQ) has funded CDS demonstrations. In addition, AHRQ and the U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) funded the development of a Roadmap for National Action on Clinical Decision Support and held workshops to support CDS system development and implementation. Most recently, the American Recovery and Reinvestment Act of 2009 (ARRA) created financial incentives through Medicare and Medicaid for providers to “meaningfully use qualified” electronic health records (EHRs). Under the Notice for Proposed Rulemaking (NPRM) for the EHR Incentive Program published by the Centers for Medicare & Medicaid Services (CMS), the criteria for meaningful use include the implementation of five CDS rules, including the ability to track compliance with those rules.

“The incorporation of evidence-based guidelines into an EMR by using CDS interventions that include quality measures may help align care delivery with payment incentives. Federal and private payers’ current and proposed payment models offer incentives based on the quality of care provided.  CDS alerts, reminders, and standardized order sets can also help clinicians follow these guidelines and support the payment of clinicians based on their performance (e.g., pay-for-performance). In addition, CDS documentation can be used to evaluate care from a population-based perspective and to move from the measurement of care processes to the measurement of patient outcomes.”

Overview of AHRQ’s Clinical Decision Support Demonstration Projects

“In 2008, AHRQ funded two demonstration projects in support of the design, development, and implementation of CDS systems. These projects aimed to:

• Incorporate CDS into EMRs that have been certified by the Certification Commission for Health IT (CCHIT).

• Demonstrate that CDS can operate on multiple information systems.

• Establish lessons learned for CDS implementation relevant to the health information technology (IT) vendor community.

• Assess potential benefits and drawbacks of CDS, including effects on patient satisfaction, measures of efficiency, cost, and risk.

• Evaluate methods of creating, storing, and replicating CDS across multiple clinical sites and ambulatory practices.”

“The projects were required to select two or more clinical practice guidelines in the public domain that had not yet been translated into a broadly available electronic CDS intervention. The chosen clinical practice guidelines were to address either preventive services or management of multiple common chronic conditions. The contractors were then to implement the CDS intervention in at least one health IT product certified by CCHIT, applying American National Standards Institute (ANSI) Health Information Technology Standards Panel (HITSP) standards when available and applicable. The CDS system being developed was to be demonstrated in ambulatory settings. In addition, the projects were required to evaluate methods for creating, storing, and replicating the CDS system across multiple clinical sites and EMR systems.

“The two demonstration project contracts were awarded to Brigham and Women’s Hospital (BWH) for its Clinical Decision Support Consortium (CDSC) project and Yale University School of Medicine for its GuideLines Into DEcision Support (GLIDES) project. Each project is funded for $2.5 million for a 2-year period, with an option for AHRQ to continue funding the projects for up to an additional 3 years.”

Objectives of This Report
“This report briefly describes the two AHRQ CDS demonstrations, as well as the challenges and barriers that the contractors encountered during the initial periods of their CDS demonstration project, how they addressed these obstacles, and the effectiveness of their strategies. The goal of this report is to share the experiences of the contractors throughout the planning, design, and implementation phases to aid others who are considering funding or undertaking similar efforts.”

Methodology
“The information for this report is based on the contractors’ monthly status reports, project proposals, evaluation plans, and other documents submitted to AHRQ project officers. In addition, discussions were held with the contractors’ staff onsite and by telephone from June to September 2009. A review of the general CDS literature was also performed in order to provide a context for the contractors’ activities.”

Terminology
“The list below defines terms used throughout the report that may have multiple definitions. These definitions are used consistently throughout the document.

• “Guidelines” refers to written statements developed by medical specialty societies, disease-focused organizations, or expert panels to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.

• “Rules” refers to the abstraction of guidelines into programmable prediction statements (i.e., IF-and-THEN statements).

• “CDS Service” refers to a CDS functionality accessible over standard Internet protocols that is independent of the underlying EMR platform or programming language.

• “CDS intervention” refers to the variety of CDS applications (e.g., alerts, reminders, order sets) used to communicate knowledge to the clinician.

• “Knowledge management tool” refers to resources designed to assist with the extraction, evaluation, storage, and retrieval of guidelines, frameworks, pieces of code, and other artifacts related to CDS system development (e.g., Documentum’s Web Publisher, Content Management Services, the Guideline Elements Model (GEM) software tool GEMCutter, EXTRACTOR, Conference on Guideline Standardization (COGS) statement, Guideline Implementability Appraisal (GLIA)).

• SmartForm is an electronic form with electronic completion, dynamic sections, database calls, electronic submission, and other capabilities. It enables writing a multi-problem visit note while capturing coded information and providing sophisticated decision support in the form of tailored recommendations for care.

• Dashboard is a Web-based application available to clinicians that displays relevant and timely information to support clinical decisionmaking for patient care, quality reporting, and population management. Dashboards may support viewing of condition-specific information and/or functionality to take action (e.g., ordering of a lab test) from the application itself.”

Organization
“The remainder of this report is organized into three sections. The next section provides a description of each project and summary of the challenges and barriers faced by each of the contractors. This is followed by an analysis and discussion of their experiences. The last section offers overall conclusions and recommendations for future work to promote CDS design and implementation.”

To read descriptions of the projects and analysis and discussion, see the report pdf. This post skips to conclusions.

Lessons Learned
“The experience to date of these two contractors provides lessons that are particularly relevant to guideline developers, IT vendors, standards development organizations, health care provider organizations, and policymakers. The lessons particularly pertinent to each group are given below.”

Guideline developers:
 “Guidelines should be specific, unambiguous, and clear.

 Guideline development committees should include individuals with programming expertise and health informaticians.

 Updates of the guideline recommendations are needed. Guideline developers should consider issuing statements of update when new medical evidence is brought forth and providing regular review and updates of guidelines. For example, the USPSTF re-reviews each topic every 5 years.”

IT vendors:
 “As most organizations utilize vendor systems with hard-coded functionality, vendors should consider ways to reduce the need for an organization to rebuild the CDS content when upgrading or implementing a new EMR system (e.g., adopting a module or service-oriented approach).

 Incentives for vendor participation in CDS initiatives should be aligned with efforts, such as defining meaningful use criteria, to encourage standards adoption.”

Standards development organizations:
 “Implementation specifications and guides should be produced that simplify existing standards and support consistent application of standards for messaging, interfacing, and mapping purposes.

 The development of standards and implementation specifications and guides should accommodate appropriate clinical practice variations.

 When developing newer versions of standards, ways to reduce interoperability problems and data-mapping issues should be considered.”

Health care provider organizations:
 “The goals of CDS development and implementation projects should align with organizational priorities to promote buy-in from both management and staff.

 The organizational working environment should foster meaningful EMR usage, including not only software and hardware needs but also the attitudinal changes needed to support adoption.

 Engaging a well-respected clinician “champion” to lead CDS education, training, and implementation efforts will promote clinician adoption.

 Institutions wishing to utilize a knowledge management process will need access to personnel with specialized knowledge in clinical informatics and experience in designing new tools or using existing tools to support CDS development.”

Policymakers:
 “The development of standards and clinical guidelines can promote the goals for interoperability as well as support the development of the knowledge base necessary for developing CDS systems.

 Incentives by funding bodies, including governmental entities, can promote EMR installation, implementation, and use of these systems. To achieve the promise of EMR to improve the quality of health care through interventions such as CDS systems, policymakers need to continually reexamine ways to promote adoption of quality practices, including performance-based payments, incentives, and providing clinicians and patients with comparative data.”

Future Work To Support CDS
“Although the contractors were able to overcome many of the challenges and barriers they faced, they were not able to overcome them all. Additional research and work are needed to address these outstanding obstacles, as they are important for the advancement of the design and implementation of CDS systems. These include:”

° “Development of a stronger evidence base for guidelines (single conditions, comorbidities, associated treatment options).

° Creation of more specific implementation guides and specifications to promote consistent application of standards.

° Comparison of the resources required by a provider organization to develop its own knowledge management system vs. use of a ready-made knowledge management portal.

° Long-term evaluation to determine whether clinicians’ use of the EMR and CDS systems changes or stabilizes over time.

° Understanding of factors that enable EMR and CDS intervention acceptance and use by clinicians.

° Effectiveness of the various CDS interventions on clinician performance and clinical outcomes.”

The Two Demonstration Project Teams

1. Clinical Decision Support Consortium
“The CDSC project was awarded to Brigham and Women’s Hospital and also includes Partners HealthCare System (Partners), an integrated health care system that includes primary care and specialty clinicians, community hospitals, two founding academic medical centers (including BWH), specialty facilities, and other health-related entities. For this project, BWH is collaborating with the Regenstrief Institute, the Veterans Health Administration (Roudebush Veterans Administration Medical Center), Kaiser Permanente, the University of Medicine and Dentistry of New Jersey (UMDNJ), MidValley Independent Physicians Association (MVIPA), and EMR vendors (i.e., Siemens Medical Solutions, GE Healthcare, and NextGen). Management of and technical expertise for this project are provided by staff of the Partners HealthCare System’s Clinical Informatics Research and Development (CIRD) group.”

2. GuideLines Into DEcision Support
“The GuideLines Into DEcision Support (GLIDES) project is a collaboration between Yale University School of Medicine, Yale New Haven Health System, and the Nemours Foundation.”

‘Building & Maintaining Sustainable HIE’ Webinar: Experience from Diverse Care Settings

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AHRQ Sponsors May 14 Webinar on HIE with Frisse, Perez, and Fontaine
Building and Maintaining a Sustainable Health Information Exchange (HIE): Experience from Diverse Care Settings
RESCHEDULED TO FRI, MAY 14, 2010:
3:00 PM Eastern 2:00 PM Central, 1:00 PM Mountain, 12:00 PM Pacific

(Originally scheduled for April 26, 2010.)
Revised and excerpted from AHRQ Web site on April 26, 2010

“This free 90-minute teleconference will explore successfully implemented HIE systems and efforts to improve patient care through sustainable electronic exchanges.”

Presenters:
Mark Frisse, M.D., M.S., M.B.A., “is Professor of Biomedical Informatics at Vanderbilt University. He created and directed a federal- and state-sponsored HIE in the greater Memphis area with over 5 million records covering the care of over 1,200,000 individuals. He is co-chair of the Markle Foundation’s Connecting for Health Common Framework policy group developing model data sharing agreements as well as a member of the American Medical Association’s Health Information Policy Committee.”

 Gina Perez, M.P.A., “is President of Advances in Management, Inc., a management consulting firm. Since 2004, Advances in Management has been engaged by the Delaware Health Information Network to provide project direction for the Health Information Exchange Project—a statewide effort to create an interoperable health care system in Delaware.   In this role, Ms. Perez provides strategic direction and day-to-day executive management for the DHIN reporting to the Board of Directors.  In the spring of 2007, the Delaware Health Information Network went live and became the first statewide health information exchange in the nation.”

Patricia Fontaine, M.D., M.S., “is Associate Professor of Family Medicine and Community Health at the University of Minnesota Twin Cities. She divides her time between teaching and clinical research… She also currently serves as president of the Minnesota Academy of Family Physicians and chair of the Minnesota Academy of Family Physicians.”

Webinar Summary
“Dr. Frisse will begin the teleconference by providing an overview of advances in developing sustainable HIEs. He will discuss factors that assisted Mid South eHealth Alliance’s successful HIE roll-out to multiple emergency departments and ambulatory care centers with a review of the challenges unique to this setting.  Ms. Perez will present strategies used by the Delaware Health Information Network to improve care for patients transitioning between care settings as well as their innovative efforts to reduce the cost of HIEs for providers and payers. Dr. Fontaine will conclude the presentations by examining barriers to participation in community-wide HIEs. She will explain the challenges faced by small and medium-sized primary care practices and her experiences working with these practices in Minnesota.”

Registration

Managing Personal Health Information: An Action Agenda from AHRQ Workshop

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Executive Summary from AHRQ Workshop:
“Managing Personal Health Information:
An Action Agenda” 
Mary Mosquera reported in Government HealthIT on April 12, 2010 “The Agency for Healthcare Research and Quality (AHRQ) released a set of recommendations last week calling for health IT vendors to focus more of their attention on the needs of consumers in developing electronic health record systems.”

Per AHRQ Web site accessed March 13, 2010, “Managing Personal Health Information: An Action Agenda (PDF, 828KB) provides a framework for studying personal health information management and patient-centered health IT to advance research, implementation, and policy development in this field through specific recommendations and an action agenda. These recommendations will be useful for health IT researchers, industry, and policymakers.”

The executive summary of the report, dated March 2010, is excerpted below.

Report PDF
Executive Summary

Background
“This report presents key recommendations and an action agenda developed during a 2-day workshop convened by the Agency for Healthcare Research and Quality (AHRQ) on July 27-28, 2009, entitled “Building Bridges: Consumer Needs and the Design of Health Information Technology.‖ The purpose of this event was to develop a framework for characterizing personal health information management (PHIM) that would inform the design of effective consumer health information technology (health IT) systems. The workshop brought together leaders from multiple disciplines, including health sciences, health informatics, information science, consumer health IT, and human factors research, with specific expertise in the fields of PHIM and/or health IT. The workshop moderator was Patricia Flatley Brennan, who also served as an advisor on this report.

“Through small-group discussions and presentations, the participants considered the diverse needs of different consumer groups with respect to managing their personal health information and how consumer health IT solutions can be designed to better meet those needs. Based on these discussions and presentations, the participants were asked to set an agenda for advancing the field of consumer health IT that would include specific recommendations for research, industry, and policy.”

Key Workshop Themes
“Effective management of personal health information empowers patients to actively partner with their health care providers in making important health care decisions, which can potentially lead to better health care and better health care outcomes. At the same time, PHIM involves a complex array of tasks that many consumers find challenging. These tasks may include tracking and integrating health-related information obtained from various sources; coordinating care across different health care providers; and making critical decisions about one’s health based on physician recommendations, test results, office visits, and other bits and pieces of personal medical information. The requisite tasks can be even more complicated for individuals with special needs, such as the elderly, whose health care needs often exceed those of the general population, and whose capacity to effectively manage those needs is typically compromised by poor health or other considerations.

“In light of these considerations, workshop participants were asked to share their understanding of consumers’ current PHIM practices, and to identify what more needs to be known about those practices in order to design better consumer health IT solutions. Participants were also asked to consider the extent to which currently available tools meet consumer needs, and what changes or design innovations would be needed to produce more patient-centered health IT systems. The following points highlight the main themes that emerged from the workshop.”

Defining PHIM
“Health care consumers manage their personal health information in countless different ways, and many factors influence the methods they use to perform the tasks and activities that characterize PHIM, such as health status, age, and attitudes about health and medical care. Moreover, a consumer’s health information management practices can change over time as his or her capacities, health status, family status, and needs change. PHIM can occur anywhere, anytime; in other words, it is not restricted to a single, isolated location or event like a doctor’s office or a medical appointment. All of these considerations have important implications for the design of consumer health IT systems. For example, they point to the need for systems that are flexible and accessible to different types of users and across different settings.”

Design Issues
“Consumer health IT solutions can play an important role in enabling patient-centered care, which the Institute of Medicine (IOM) defines as “providing care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions‖ (IOM, 2001). In order to truly benefit consumers in this way, however, consumer health IT solutions must, first and foremost, take into account the particular needs of the consumer, rather than the needs of the physician, the insurance company, or some other entity that has a stake in the patient’s health care.

“To ensure broad access to these solutions, developers will also need to consider the particular needs, goals, preferences, and capacities of subpopulations like the elderly, the chronically ill, the disabled, and the underserved, which typically face one or more barriers that interfere with their ability or willingness to use consumer health IT systems. Specific barriers may include access to, and comfort with, technology; cognitive and physical impairments; health literacy; and cost. Until the needs of these subpopulations, who likely pose the most challenging design considerations, are taken into account, the IT solutions that developers create will likely fall short of promoting patient-centered care.

“Consistent with the principles of patient-centered care, these tools must also reflect respect for the patient. Specifically, these tools should, among other things, ensure that the patient decides who has access to his or her personal health information, and, for those tools that are interactive, they should communicate information to the patient in a way that the patient can easily understand.

“In order to ensure that consumers will actually use consumer health IT solutions, it will also be important to design those solutions to fit seamlessly into the user’s life.”

Important Steps for the Advancement of Consumer Health IT
“Workshop participants identified several steps that can be taken to promote innovation in consumer health IT. Key points included:

“Build a knowledge base about consumers’ PHIM needs and practices and related design principles. Additional research is needed on consumers’ PHIM practices and related design issues in order to develop consumer health interventions that can best support consumers in effectively managing their health and health-related information.

“Support more interdisciplinary efforts to drive innovation. Collaboration between academic institutions and the technology industry could lead to significant advances in consumer health IT, but too many factors prevent the two types of entities from working together. Within the technology industry, information sharing could potentially lead to better, more efficient designs, yet developers tend to avoid such alliances out of concern for the potential costs and risks of collaborative efforts. To facilitate more partnerships across and within academia and industry, mechanisms will need to be established that reward collaboration and protect the rights and investments of all stakeholders.

“Build a more robust health IT infrastructure to ensure access to all health care consumers. Innovations in consumer health IT will require the development of a robust infrastructure that can support the dissemination of new solutions across different platforms. This infrastructure will need to ensure that consumers have access to the technology regardless of their age, income, literacy level, or other potential barriers.”

Recommendations

A. Research
1. User Needs and Context
     Recommendation 1a: “To inform the design of PHIM tools, technologies, and applications, research is needed to investigate: The needs and preferences of diverse user groups in different contexts., User goals, activities, and PHIM practices. User capacities (e.g., cognitive, physical, health literacy). User motivation (including beliefs and preferences).

     Recommendation 1b: “To address current gaps in knowledge, researchers should develop a taxonomy of needs and users that can be mapped to design strategies

     Recommendation 1c: “To inform the design of IT-based PHIM tools for the broader population, researchers should identify and study “expert‖ consumer groups (e.g., frequent health care consumers) as models.”

2. Improving Design of Consumer Health IT
“To improve consumer health IT design, researchers should:
     Recommendation 2a: “Investigate the application of design methodologies used in other industries to PHIM.

     Recommendation 2b: “Identify qualitative and quantitative metrics for evaluating good design.

     Recommendation 2c: “Test design feasibility before development.

     Recommendation 2d: “Identify and evaluate intervention strategies that encourage and facilitate adoption of consumer health IT among users.”

3. Evaluation Research
     Recommendation 3a: “Rigorous research is needed to examine the impact of consumer health IT use on various outcomes (including behavioral, clinical, patient experience, provider experience, efficiency, and unanticipated outcomes), and the specific relationship of design to those outcomes.

     Recommendation 3b: “New research methods and approaches need to be developed to evaluate PHIM systems that are already in the field.”

B. Industry and Policy
     Recommendation 1: “To advance the development of innovative consumer health IT solutions, new mechanisms need to be established that can facilitate collaboration between industry and academia.

     Recommendation 2: “To help support the development of consumer health IT solutions that meet the needs of all consumers, incentives should be established for industry to invest more resources in Research & Development of such solutions.

     Recommendation 3: “To build awareness about PHIM among young health care consumers, grade-appropriate PHIM education should be incorporated into school curricula.

     Recommendation 4: “Policymakers and industry stakeholders should agree upon and establish standard ethical guidelines for the use and reuse of personal health information.

     Recommendation 5: “To promote the development and adoption of consumer health IT, new and existing policy implications need to be evaluated.

     Recommendation 6: “To enable patient-centered care and ensure broad access to consumer health IT, policymakers and industry stakeholders need to identify ways to build a more robust health IT infrastructure.”

Related AHRQ Reports from October 2009
“New AHRQ-Funded Reports on the Usability of Electronic Health Record (EHR) Systems”

“To explore the opportunity to improve EHR system usability, AHRQ commissioned the creation of two reports that synthesize the existing research and evidence in this area and suggest common methods to evaluate EHR usability going forward.

“Electronic Health Record Usability: Evaluation and Use Case Framework (pdf) synthesizes the literature and best practices regarding the usability of EHRs, and it provides a set of use cases to evaluate information design in primary care IT systems.

“Electronic Health Record Usability: Interface Design Considerations provides recommended actions to support the development of an objective EHR usability evidence base and formative policies to systematically improve the usability of EHR systems.”

Beyond Meaningful Use: Learning Health System, a Theme of Listening Session

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Beyond Meaningful Use: Listening Session Looks Ahead to The Learning Health System
The April 6, 2010 listening session (audio link below) for the draft framework for the Health IT Strategic Plan pointed to a concept more far reaching than meaningful use: the Learning Health System. One of the four themes proposed by the Health IT Committee Strategic Plan Workgroup, the  Learning Health System, is based on the charter of  the Institute of Medicine’s Roundtable on Evidence-Based Medicine, since renamed the Roundtable on Value & Science-Driven Health Care.

One of the transformational concepts underlying the learning system moves the physician beyond reliance on their solo expertise toward working in collaboration with the patient, other clinicians, and continuously updated  data resources and scientific evidence to improve patient care.

“A learning health system” according to a slide from the listening session citing the Institute of Medicine, ”is a system that is designed to generate and apply the best evidence for the collaborative health care choices of each patient and provider; to drive the process of new discovery as a natural outgrowth of patient care; and to ensure innovation, quality, safety, and value in health care.”

The prior week, the Roundtable sponsored its latest Workshop,  April 1-2, 2010, in Washington, DC, which was  titled “The Learning Healthcare System in 2010 and Beyond: Understanding, engaging, and communicating the possibilities.” The Roundtable, in describing its work, says it develops meetings and projects with leaders from a range of healthcare sectors to achieve “its goal that by 2020, ninety percent of clinical decisions will be supported by accurate timely, and up-to-date clinical information, and will reflect the best available evidence.”

ONC’s Health IT Strategic Framework:
The Learning Health System 
The following section on the Learning Health System, one of four themes, is excerpted from the pre-decisional draft of the ONC’s Health IT Strategic Framework that was discussed at the April 6 listening session of the HIT Policy Committee Strategic Plan Workgroup.
PDF version of draft Framework

Theme 4: Learning Health System 

a. Goal:
Transform the current health care delivery system into a high performance learning system by leveraging health information and technology. 

 b. Principles |
          1. Health information should be used to facilitate rapid learning and innovation in diagnosis, treatment, and decision making to improve health outcomes and to enhance health system value. 

          2. HIT should help engage patients and providers to take active roles in creation and application of evidence-based care.  

c. Objectives 
          1. Use HIT methodologies, policies and standards to foster creation of knowledge across a large network of distributed data sources, while protecting privacy and confidentiality. 

          2. Engage public and private sectors stakeholders at the national, regional, and local levels to effectively leverage data and human resources to advance care delivery, alignment of payment with outcomes, research (e.g., clinical research, comparative effectiveness research), public health (e.g., drug safety monitoring, outbreak surveillance), education (e.g., K-12, colleges, professional schools, professional lifelong learning) and social services to promote and maintain community health. 

           3. Support individuals decision on making their data be used for society (e.g., research and public health), while protecting their privacy. 

          4. Leverage data from populations to expand knowledge and promote scientific discoveries that advance the understanding of health, disease, and treatments. 

d. Strategies 
          1. Continuously evaluate successes and lessons learned through HIT adoption, and actively incorporate best practices into the HIT programs and services. 

                              Provide mechanisms to assess and continuously improve EHR safety. Explore and develop EHR safety measures and reporting mechanisms as learning processes to improve the safety of EHRs. 

           2. Reward, showcase, and leverage industry best practices and innovative uses of HIT to create an active community learning system that supports advances in health promotion and treatment of diseases in the US. Make knowledge and technology accessible to health care professionals and consumers. 

          3. Engage all levels of the public and private sectors, along with the international community, in coordinated activities to advance population health (public health, biomedical research, quality improvement, and emergency preparedness) by using common policies, standards, protocols, legal agreements, specifications, and services for data sharing and building knowledge. 

          4. Stimulate and support innovations in care delivery, performance measurements, genomics, and comparative effectiveness through HIT. 

                             Support research and development activities to overcome obstacles that impede creation of learning systems.  

           5. Incorporate the global health dimension into the interoperability requirements of the learning system infrastructure.  

           6. Harmonize the meaningful-use requirements with the dual needs of population health (clinical research, comparative effectiveness, public health) and a learning system. 

          7. Through a comprehensive education and communications campaign, promote a shared vision of a learning health system and the role of HIT in helping to create it. 

                         Develop and implement educational material and tools to improve consumers’ health and HIT literacy and to promote self management and self efficacy using HIT. 

                        Communicate with professional societies and boards to identify opportunities for meaningful use activities to contribute to professional education programs. 
END OF EXCERPT

Additional Resources:
See earlier post from e-Healthcare Marketing on Listening Session on Strategic Framework.

Materials and audio from April 6, 2010 Listening Session.

Meeting Materials
Meeting
Audio

IOM April 1-2, 2010 Roundtable: “The Learning Healthcare System in 2010 and Beyond: Understanding, engaging, and communicating the possibilities”

Use the tool below to view free online published version of 2006 IOM Workshop on the Learning Health System.
 

NJ Open Forum on Privacy & Security in HIE: Health IT Commission Policy Cmte — Apr 12, 2010

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Open Forum on Privacy & Security in Health Information Exchange:
New Jersey Health IT Commission Policy Committee
April 12, 2010, 1-4 p.m.
Location: New Jersey Hospital Association
760 Alexander Road
Princeton, NJ 08543-0001

AGENDA (pdf version)
1. Opening remarks: Al Gutierrez and Helen Oscislawski
2. Discussion of Checklist of Outstanding Privacy & Security Issues
          i. Review of law and best practices in HIE (NJ Administrative Code;   Markle/HISPC/ONC/IHE/AHIMA)
        ii. Recommendations for each item on ‘Checklist’
       iii. Development of recommended language for common forms (Consent, Notice of Privacy Practices, Trust Agreement, etc)
3. Open discussion of Current Challenges in HIE
         i. What are the remaining hurdles to exchanging data?
        ii. What are the remaining hurdles to establishing an operational exchange?
4. Wrap-up: Future Items to be Addressed by Health IT Commission, State

NJ Health IT Commission