Office of the National Coordinator for Health Information Technology

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• Office of the National Coordinator for Health
  Information Technology

Medical Professional Liability and Electronic
Health Records
Karen M. Bell MD MMS Director, Office of HIT
Adoption Department of Health and Human
Services March 14, 2008
U.S. Department of Health and Human
Services Office of the National Coordinator for
Health Information Technology
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HIT Key Components

• EHRs providers create, import, store, and use
  clinical information for patient care
• PHRs individuals create, import, store, and use
  clinical information to support their own health
• Health Information Exchange the electronic
  movement of health-related data and information
  among providers, patients, and other entities
  according to agreed upon protocols

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Current State EHR Adoption US Physicians, 2007

• Range up to 28 using some functions
• 14 with electronic note keeping, lab and med
  orders, and ability to obtain lab results
• 7 of solo physicians
• 28, 11 or more physicians in practice
• 3X more prevalent in metropolitan areas

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Current State EHR Adoption Hospitals 2007

• 68 with full or partial adoption
• 11 with fully implemented EHRs
• Size matters 3(lt50 beds) to 23 (gt500 beds)
• Full implementation does not represent physician
  use (fourth of implemented hospitals report 50
  MD use.)

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Workgoup Broad Charges

• EHR Workgroup Make recommendations to the
  Community on ways to achieve widespread adoption
  of certified EHRs, minimizing gaps in adoption
  among providers.
• Consumer Empowerment Make recommendations to
  the Community to gain wide spread adoption of a
  personal health record that is easy-to-use,
  portable, longitudinal, affordable, and
  consumer-centered.

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Areas of Focus

• Business Case
• Technical Considerations
• Privacy and Security Concerns
• Medical Legal Issues
• Organizational/Cultural Issues (Workflow,
  Workforce, Public expectations, etc.)

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Business Case Barriers

• Physician office average cost 20,000/user of
  software, installation, loss of productivity
  hardware additional
• Recent findings suggest no financial ROI to
  physician providers in todays environment
• ROI accrues to payers of health care

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Business Case Enablers

• Certification of products, decreased risk of
  failed investment
• Stark amendment and anti-kickback relief allowing
  hospital donations to physicians
• HRSA grants to rural and community based
  federally qualified health centers
• Malpractice fee credits
• Selected private and public (CMS demonstration
  project) insurer incentives based on adoption and
  effective use of EHR functions, leading to
  improved performance on specified metrics

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The CCHIT

• Founded in 2005
• Multi-stakeholder public/private partnership with
  a public process
• Criteria for functionality, security, and
  interoperability (accepted by Secretary, DHHS)
• First ambulatory EHR products certified 2006
• Currently covers 75 to 80 of installed market
• Over 25 of ambulatory EHRs now in use have been
  certified
• Ongoing process new functionalities, new
  interoperability standards, specialty EHRs, new
  settings, PHRs, interoperable networks

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CCHIT Ambulatory Roadmap
CardiovascularMedicineAdditionalCriteria
and/orSpecializedCase Scenario
FutureSpecialty Additions
Child Health Criteria
ED EHRCriteria
InpatientEHR Criteria
AmbulatoryEHR Criteria
DomainCriteria
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Technical considerations Barriers

• No killer apps (usability an issue)
• CCHIT criteria for some key functionalities still
  in development (registry functions,
  administrative processes, etc.)
• Cost of interfaces with multiple other providers
  (labs, hospitals, radiology centers, etc.)

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Technical Considerations Enablers

• Harmonized interoperability standards prioritized
  for key clinical data
• Certification guarantees state of the art
  security criteria
• CCHIT criteria roadmap
• Development of Health Information Exchange
  organizations

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Privacy and Security Concerns

• Control of information and flow
• Breaches of security
• Consequences (loss of insurance, work, or other
  forms of discrimination)
• Secondary Uses of Data
• Genomic and Family History affect family members

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Privacy and Security Policy Development in
Progress

• Authentication
• Authorization
• Patient Identify Proofing and Linkage
• Principles and Policies for Secondary Uses of
  Information
• Protection from discrimination based on Genetic
  Information (GINA)
• Health Information Portability and Accountability
  Act

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Medico-Legal Concerns

• Erroneous or incomplete information
• Responsibility for information not requested
• Management of large amounts of data
• Responsible for breaches of confidentiality
• Disabling of intrusive decision support modules

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Medico-Legal Risk Mitigation

• Most concerns also exist in paper world
• Physicians using comprehensive EHRS in large
  Integrated Delivery Systems not overwhelmed by
  data
• Almost all physicians use the functionalities
  available to them
• CCHIT certified functionalities

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Prevention of Liability CCHIT

• Improved aggregation, analysis and communication
  of patient level information for patient care
• Diagnostic and therapeutic decision support
• Prevention of adverse events
• Documentation of informed consent
• Demonstrated adherence to evidence based best
  practices
• Audit trails re who makes what entry when

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Organizational Concerns

• Lack of vision within office or organization
• Workflow redesign cumbersome
• Inadequately trained workforce
• Patient/Consumer wariness

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Organizational Enablers

• Highest level of Federal Gov is engaged and
  focused on HIT, and actively engaging major
  employers, insurers, and providers
• DOQ-U available on line to all clinicians
  interested in adoption and needing consultative
  support for the process and accompanying workflow
  redesign
• Implementing AHIC recommendations to better
  support workforce development
• Widespread marketing to general population

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Summary Federal Support for widespread adoption
of Certified EHRs

• Business case CMS EHR demo HRSA grants
  Stark relaxation and Anti Kickback relief
  Certification process to decrease risk of failed
  investment and medical liability ROI analyses
• Technical Use cases and interoperability
  standards to support patient care and health
  information exchange
• Privacy and Security clarification of HIPAA
  with minimal variance in interpretation across
  states, Privacy and Security Principles, CCHIT
  criteria for security
• Workflow/workforce DOQ-IT and DOQ-U
  workforce recommendations re DOL and DOE
• Medical legal CCHIT functions to decrease risk
  of MPL. Engagement of malpractice insurers

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Thank You!

• Karen.Bell_at_hhs.gov
• www.hhs.gov/healthit