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

1. April 18, 2012

2. Framework: Federal Health IT Strategic Plan
Goal
The Plan Translation
Number
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. Innovate
and Iterate
Empower
Individuals
Confidence
and Trust
Triple Aim
Adoption
and
Alphabet Exchange
Soup

4. Alphabet Soup – The Technology
Electronic Health Record (EHR)
Health Information Exchange (HIE)
Mobile Health (mHealth)
ePrescribing (eRx)
Computerized Physician Order Entry (CPOE)

5. Alphabet Soup – (Some) Feds
Executive
Branch
EOP
OSTP
DOC HHS DOD VA Ind. Est.
NIST FCC
FTC
Source: http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=GOVMAN

6. Alphabet Soup – The (HHS) Feds
HHS
CTO OS
ONC ASPE
ASPA OCR
CIO
FDA HRSA AHRQ CDC NIH SAMHSA IHS

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. 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 FR
Source: http://www.regulations.gov/#!home

9. Innovate, and
Iterate
Empower
Individuals
Confidence
and Trust
Triple Aim
Adoption and
Exchange
Alphabet
Soup

10. Adoption and Exchange
Goal One: “Achieve Adoption and Information Exchange through
Meaningful 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. CMS’ Meaningful Use Requirements
Use Certified EHR to meet Core
Objectives
• 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. 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. MU Stage 2 -- Ambulatory
of 5 Menu CQM
 Certified
17 Core
Objectives 3 Objectives
(of 5)
12 (Or
PQRS)

14. MU Stage 2 -- Hospitals

Menu
Certified
16 Core
Objectives 2 Objectives
(of 4) 24 CQM

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 and
policies that enable secure health information exchange over the Internet.
•Being developed by HHS
•National Information Exchange Model: foundation for information exchange
that provides a common vocabulary, data model, governance, methodologies.
•Health and Human Services Domains are under development
•Federal Health Architecture: being developed to ensure that agencies
seamlessly and securely exchange health data with other agencies,
government entities, and other public and private organizations.

16. Adoption
Source: http://www.cdc.gov/nchs/data/factsheets/factsheet_nhcs.htm

17. Innovate
and Iterate
Empower
Individuals
Confidence
and Trust
Triple Aim
Adoption
and
Alphabet Exchange
Soup

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. “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. “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. Innovate
and Iterate
Empower
Individuals
Confidence
and Trust
Triple Aim
Adoption
and
Alphabet Exchange
Soup

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. 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. 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. 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. Safety – IOM Recommendations
HHS should specify a
ONC should work to
HHS should publish an HHS should ensure Risk Management
make comparative user
action 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 an
should 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. 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. 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. 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. 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. 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. Innovate
and Iterate
Empower
Individuals
Confidence
and Trust
Triple Aim
Adoption
and
Alphabet Exchange
Soup

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. 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. 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. 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. Innovate
and Iterate
Empower
Individuals
Confidence
and Trust
Triple Aim
Adoption
and
Alphabet Exchange
Soup

38. Innovate and Iterate
Goal Five: “Achieve Rapid Learning and technological Advancement.”

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. 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 use
http://www.hhs.gov/open/initiatives/hdi/about.html

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. 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. 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. “Do it more, do it bigger, and do it faster.
– Secretary Sebelius