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Health IT and the Feds

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Comprehensive assessment on the federal government's progress on their 2011-2015 Health IT Strategic Plan.

Published in: Health & Medicine

Health IT and the Feds

  1. 1. April 18, 2012
  2. 2. Framework: Federal Health IT Strategic Plan Goal The Plan TranslationNumber 1 Achieve Adoption and Information Adoption and Exchange Exchange through Meaningful Use of Health IT 2 Improve Care, Improve Population The Triple Aim Health, and Reduce Healthcare costs through the use of Health IT. 3 Inspire Confidence and Trust in Health Confidence and Trust IT 4 Empower individuals with IT to improve Empower Individuals their Health and the Healthcare System 5 Achieve Rapid Learning and Innovate and Iterate technological Advancement
  3. 3. Innovate and Iterate Empower Individuals Confidence and Trust Triple Aim Adoption andAlphabet ExchangeSoup
  4. 4. Alphabet Soup – The Technology Electronic Health Record (EHR) Health Information Exchange (HIE) Mobile Health (mHealth) ePrescribing (eRx) Computerized Physician Order Entry (CPOE)
  5. 5. Alphabet Soup – (Some) Feds Executive Branch EOP OSTP DOC HHS DOD VA Ind. Est. NIST FCC FTCSource: http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=GOVMAN
  6. 6. Alphabet Soup – The (HHS) Feds HHS CTO OS ONC ASPE ASPA OCR CIO FDA HRSA AHRQ CDC NIH SAMHSA IHS
  7. 7. Alphabet Soup – The Legislation Food, Drug, and Cosmetic Act of 1938 (FD&C) Health Insurance Portability and Accountability Act of 1996 (HIPAA) Food and Drug Amendments Act of 2007 (FDAAA) American Recovery and Reinvestment Act of 2009 (ARRA) Health Information Technology for Economic and Clinical Health (HITECH) Patient Protection and Affordable Care Act of 2010 (PPACA or ACA) America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act of 2007 (extended in 2010)
  8. 8. Alphabet Soup – The Terminology • Not Binding: Guidances describe the agency’s current thinking on a regulatory issue. • Legally Binding: Rules, or “Regs,” are issued after an agency is granted authority to do so by law. • Three stages of a Rules’ Life: ANPRM NPRM FRSource: http://www.regulations.gov/#!home
  9. 9. Innovate, and Iterate Empower Individuals Confidence and Trust Triple Aim Adoption and ExchangeAlphabetSoup
  10. 10. Adoption and ExchangeGoal One: “Achieve Adoption and Information Exchange throughMeaningful Use of Health IT” EHR Adoption Exchange Standards Meaningful Use of EHRs via the State HIE Programs HITECH Stimulus (~20.8 Billion) Regional Extension Centers S/I Framework, NwHIN, FHA
  11. 11. CMS’ Meaningful Use RequirementsUse Certified EHR to meet CoreObjectives• Use of certified EHR in a meaningful manner.Participate in HIE• Use of certified EHR technology for electronic exchange of health information to improve quality of health care.Report CQMs• Use of certified EHR technology to submit clinical quality measures (CQM) and other such measures selected by the Secretary [of Health].
  12. 12. MU Stage 2 Objectives Quality, Safety, Efficiency, Health Engage Patients and their Families Care Coordination Population and Public Health Privacy and Security Disparities• CPOE • View/Download • Medication Reconciliation • Immunization Registry • Protect PHI• eRx • Clinical Summaries • Summary of Care for TOC • Reportable Lab Results• Demographics • Education Resources • Syndromic Surveillance *• Vital Signs • Secure Messaging • Specialized Registry *• Smoking Status • Cancer Registry*• CDS• Structured Lab Results• Patient Specific Lists• Patient Reminders• eMAR• Advanced Directives *• Imaging Results*• Family History*• d/c eRx* Key: Both EP and EH EP Only EH/CAH Only * Menu
  13. 13. MU Stage 2 -- Ambulatory of 5 Menu CQM Certified 17 Core Objectives 3 Objectives (of 5) 12 (Or PQRS)
  14. 14. MU Stage 2 -- Hospitals Menu Certified 16 Core Objectives 2 Objectives (of 4) 24 CQM
  15. 15. Health Information Exchange•S/I Framework is one stop shopping for: •Content •Vocabulary •Transport Standards•Nationwide Health Information Network: a set of standards, services andpolicies that enable secure health information exchange over the Internet. •Being developed by HHS•National Information Exchange Model: foundation for information exchangethat provides a common vocabulary, data model, governance, methodologies. •Health and Human Services Domains are under development•Federal Health Architecture: being developed to ensure that agenciesseamlessly and securely exchange health data with other agencies,government entities, and other public and private organizations.
  16. 16. AdoptionSource: http://www.cdc.gov/nchs/data/factsheets/factsheet_nhcs.htm
  17. 17. Innovate and Iterate Empower Individuals Confidence and Trust Triple Aim Adoption andAlphabet ExchangeSoup
  18. 18. Triple Aim Goal Two: “Improve Care, Improve Population Health, and Reduce Healthcare costs through the use of Health IT.” The best care, for the at the whole lowest population. cost,Source: www.IHI.org
  19. 19. “Best Care” at the “Lowest Cost” “You don’t know what you don’t measure” Various CMS programs require or incentivize quality measure reporting: • Meaningful Use • Hospital Value Based Purchasing Program • Pay-for-Performance (P4P) • Physician Quality Reporting System (PQRS) • Medicare Part D Assessment through Pharmacy Quality Alliance (PQA) Measures Reporting: ONC’s popHealth Tool Empowers healthcare providers to perform Meaningful Use quality measure reporting and promotes easier submission of quality measures to public health organizations
  20. 20. “for the whole population” Care Coordination: Accountable Care Organizations Patient Centered Medical Homes Secondary Use: Query Health: plans to make clinical information available to researchers nationally, to study population health Sentinel: FDA initiative mandated by FDAAA to enhance pharmocovigilence through a national electronic system
  21. 21. Innovate and Iterate Empower Individuals Confidence and Trust Triple Aim Adoption andAlphabet ExchangeSoup
  22. 22. Confidence and Trust Goal Three: “Inspire Confidence and Trust in Health IT” Lots of moving parts = lots of failure modes: “is my data secure?” “is my data private?” “is that EHR useable?” “did that dose calculate correctly?” “will the monitoring company get my ekg?”
  23. 23. Privacy and Security – HIPAA HITECH changed HIPAA – now applies to covered entities and business associates Protected Health Information: all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic (ePHI), paper, or oral (PHI). Privacy Rule – Gives the consumer rights over his/her health information Sets rules and limits on who can view or receive his/her health information. Security Rule – administrative, physical and technical safeguards
  24. 24. Safety – IOM Report on EHR Safety IOM was tasked with looking at how Health IT impacts patient safety and make recommendations on how public and private actors can maximize the safety Scope: Focus: Patient safety as it relates to health IT and the delivery of care Did not consider: whether Health IT should be implemented, access to health IT products, medical liability, privacy, security, standards
  25. 25. Safety – IOM Conclusions Technology does not exist in isolation from its operator – they are interdependent. Safer Health IT implementation will be the result of sharing responsibility between vendors and HCOs. Failure Points mentioned: Problems in Implementation/Acquisition/Maintenance Workflow Redesign Poor user-interface design (Usability) Customization VS Standardization Interoperability HCO Size (Small Practices/Hospitals) “Report here now” Button
  26. 26. Safety – IOM Recommendations HHS should specify a ONC should work toHHS should publish an HHS should ensure Risk Management make comparative useraction and surveillance vendors share patient process for vendors: experience data plan w/in 12 months. safety data. human factors, safety available. culture, usability. HHS should recommend All Health IT vendors HHS should establish a A new Health IT Safety Congress establish anshould list their products way for vendors and Council should be independent federal with ONC in a single users to report health IT established by HHS. entity for investigating database. related ADR. ADR.If all else fails, have the Keep doing research. FDA regulate it.
  27. 27. Safety – FDA’s Mobile Medical Apps FDA’s Draft Mobile Medical Apps Guidance published in July 2011 A “mobile medical application” or “mobile medical app” is a mobile app that meets the definition of "device” in the FD&C; and its intended use is: as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.
  28. 28. Mobile Med Apps -- Regulated Displaying, Storing, or Transmitting • If a mobile medical app allows for the display/storage/or transmission of patient-specific information (PHI) in its original format, it is a medical device. This category of mobile medical apps are primarily used as secondary displays (and not for primary diagnosis/treatment decisions) and will only require Class I requirements. Controlling connected medical devices • If a mobile medical app allows for the control of another medical device, it must adhere to the regulations applicable to the connected device. These mobile medical apps can control the use, function, modes, or energy source of a regulated medical device.
  29. 29. Mobile Med Apps -- Regulated Mobile platform transformation • If a mobile medical app transforms a mobile platform into a regulated medical device, it is regulated under the class applicable to its intended use. Interpretation of Medical Device Data • If a mobile medical app is intended to analyze or interpret data from a medical device for the purposes of creating alarms, recommendations, or information, is considered an accessory to the first medical device and regulated under the first medical device’s class.
  30. 30. Mobile Medical Apps – Maybe Regulated “Regulatory discretion will be used regarding mobile apps which meet the FD&C’s device definition but are not an accessory to a regulated device or intended to transform a mobile platform into a regulated device. “ Applications which remind people to manually input information for logging/tracking/graphing. Patient education data viewers. Organization of personal health information - such as dosages, calories, doctor appointments, lab results, and symptoms. Over the counter medication lookup applications which provide the information available on drug labels.
  31. 31. Mobile Medical Apps – Not Regulated Non-covered apps include: Electronic versions of reference materials that do not contain patient-specific information Health/wellness applications that do not intend to cure, treat, or diagnose Automated billing, inventory, appointment, or insurance transactions Generic aids (audio recording, note taking, etc) mobile EHRs or PHRs
  32. 32. Innovate and Iterate Empower Individuals Confidence and Trust Triple Aim Adoption andAlphabet ExchangeSoup
  33. 33. Empower Individuals Goal Four: “Empower individuals with IT to improve their Health and the Healthcare System.” Voice of the Customer Control Participation Mobility Transparency
  34. 34. Blue Button DOD, VA, CMS Web Based PHR Puts the patient in the driver’s seat – Download your data in a standardized/reusable format Give your family, caregivers, and HCP access
  35. 35. A-Chess UW-Madison and SAMHSA Addiction Comprehensive Health Enhancement Support System Timely Monitoring Online peer support through group/clinical counselors Sends you a message based on GPS location “Panic Button”Source: http://www.niatx.net/Content/ContentPage.aspx?NID=164
  36. 36. Text 4 baby Free national SMS health information service. One way text messaging. Large public-private partnership. Healthy Mothers Healthy Babies (HMHB), Voxiva, The Wireless Foundation (CTIA), HHS (HRSA0, OSTP, J&J, etc. 3 messages/week. Pregnancy through first year of child’s life. Enroll: text “baby” or “bebe” to 511-411
  37. 37. Innovate and Iterate Empower Individuals Confidence and Trust Triple Aim Adoption andAlphabet ExchangeSoup
  38. 38. Innovate and IterateGoal Five: “Achieve Rapid Learning and technological Advancement.”
  39. 39. Strategic Health IT and Advanced Research Research focused on achieving breakthrough advances to address well documented problems that impede the adoption of Health IT Security Cognitive Support Platforms Secondary Use Medical Device • Developing an integrated • Examining cognitive • Using substitutable applications • Enable secondary use by • Enabling PnP standards-based security and privacy research foundations for decision in Health IT environments standardizing data integration of medical devices community for HIE, EHR, and making, adaptive decision elements, NLP, phenotyping and developing a framework for telehealth security issues support, data integrated clinical environments summarization, and visualization
  40. 40. Health Data Initiative IOM/HHS Resulted from the Open Government Directive Transform data into actionable information: Data Liberación! HHS is releasing datasets in more usable formats Software developers can use the data to create new applications for patients, providers, communities to usehttp://www.hhs.gov/open/initiatives/hdi/about.html
  41. 41. Health Data Initiative Will lead to: Raise awareness of community health Place pressure on decision makers Facilitate and inform action to improve performance
  42. 42. Prizes and Challenges America COMPETES Act -- "carry out a program to award prizes competitively to stimulate innovation.” Prize: A monetary or non-monetary reward used to incentivize innovative solutions for existing problems. Challenge: a problem or gap in performance which can be solved via the novel application of existing or the creation of new solutions
  43. 43. Prizes and Challenges Why Prizes and Challenges? Goal Based Pay only for results; Lowers Barrier to Competition Stimulate Private Sector Investment Interest the challenge topic ONC’s Investing in Innovation ("i2")
  44. 44. “Do it more, do it bigger, and do it faster. – Secretary Sebelius

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