Title: Health Information Exchanges (HIEs): The Impact of HIPAA and the HITECH Act December 4, 2009
1Health Information Exchanges (HIEs) The Impact
of HIPAA and the HITECH Act December 4, 2009
- Linda M. Kinney, MHA
- Care Share Health Alliance
- Alicia Gilleskie, Esq.
- Smith, Anderson, Blount, Dorsett, Mitchell
Jernigan, L.L.P. - David Kirby,
- KirbyIMC.com
- Dial 1-866-740-1260 Passcode 8618356
-
2Webinar Logistics
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visual portion of this webinar call
919-861-8355 - All lines will be muted during the presentation
- To ask a question during the Questions Answers
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by completing the post-webinar survey
3Webinar Overview
- Introduction to Care Share Health Alliance
Linda Kinney - Presentation Alicia Gilleskie and Dave Kirby
- Background on Health Information Exchanges,
HIPAA and the HITECH Act - The Impact of HITECH on Health Information
Exchanges - Risk management issues to consider
- Question Answer Session moderated by Linda
Kinney
4- Introduction
- Linda Kinney
5What is Care Share Health Alliance?
- Care Share is an independent, statewide resource
that brings people together to improve the health
of low-income, uninsured persons. - We do this by supporting the development of
Collaborative Networks, building collaboration
between providers and strengthening the safety
net. - We provide technical assistance around building
collaboration, program development, capacity
building, evaluation, business process
assessment, and community-wide planning. - For more information visit www.CareShareHealth.or
g
6Collaborative Networks and Data Sharing
The goals of Collaborative Networks and
collaboration between providers is to Improve
access and the delivery of services Reduce
duplication Facilitate effective and efficient
utilization of services Maintain quality of
care To do this effectively collaborative
partners must share information with each other.
Including electronic health information.
7- Presentation
- Alicia Gilleskie and Dave Kirby
8Health Information Exchanges (HIEs) The Impact
of HIPAA and the HITECH Act
- Presentation
- Background on Health Information Exchanges,
HIPAA and the HITECH Act - The Impact of HITECH on Health Information
Exchanges - Risk management issues to consider
9Health Information Exchanges (HIEs)
- What is a Health Information Exchange?
- Improved Collaboration
- Allows transparency for treatment, care
coordination, quality assessment and improvement
activities, such as case management, outcome
evaluations, development of clinical guidelines - Emerging HIEs in NC
- NC is a pioneer state in HIE implementation
10Health Information Technology for Economic and
Clinical Health Act (HITECH)
- What is HITECH?
- Enacted as part of the American Recovery and
Reinvestment Act of 2009 - Expansive changes to HIPAA aimed at encouraging
the sharing of electronic health information - Provides funding assistance and incentives to
encourage implementation of electronic health
records (EHRs)
11Key Traditional HIPAA Privacy/Security Elements
Related to HIEs
D
12The HIPAA Privacy Rule- key HIE elements
- Permission and requirements to disclose PHI
- Uses and disclosures via an HIE are still covered
under the Privacy Rules set of permitted and
required uses and disclosures. HITECH has new
requirements to disclose electronically to
patients - Mitigation of Harm
- Mitigating harm from an impermissible
use/disclosure is still a requirement that is in
effect and covers non-permitted disclosures/uses
via HIE. HIEs introduce more risk that if not
neutralized will lead to more harm to be
mitigated. New Notice of Breach provisions in
HITECH more specifically address one form of
harm.
D
13The HIPAA Privacy Rule- key HIE elements
- Accounting of disclosures
- Providing an accounting of a limited list of
disclosures (e.g. public health case reporting)
to the patient upon request is still a
requirement. A new HITECH element requires
accounting of e-disclosures for treatment,
payment and operations. Most HIE disclosures are
likely to require an accounting. Some forms of
HIEs do this automatically or avoid the need for
accounting by being the patients agent. - Provision of designated record set to patients.
- This requirement is still in effect and is
extended with a specific HITECH requirement to
transmit ePHI to patients (likely via an HIE) - Required public good disclosures (e.g. public
health reportable conditions) - These disclosure requirements are still in effect
and some forms are required to be done
electronically (likely via an HIE) under HITECH.
D
14HIPAA Security Rule key HIE elements
- Use of encryption on open networks
- Most HIEs are designed to operate on open
networks. This requirement in the Security Rule
compels the use of encryption. New HITECH
requirements make use of encryption attractive
for all PHI data flows and data stores
especially in HIEs. - Audit log collection and use
- This requirement is still present and EHR
interactions with HIEs will likely mean that more
use and review will be needed to be done to
manage the increased risks to confidentiality.
D
15HIPAA Security Rule key HIE elements
- Security incident management
- This requirement to report and respond to
security incidents will be especially important
in an HIE environment to reducing harm and
maintaining public confidence in HIE. There will
likely be more occasions when many organizations
will be involved in responding to one incident. - Data integrity
- This requires that there be protections against
loss/corruption of PHI. This becomes more
challenging in an HIE environment where new data
arrives routinely from a variety external
sources. - Data access management
- This requirement to limit access is more
challenging to meet in an HIE environment where
there are more people with changing access rights
over shorter periods of time. Person-oriented HIE
models let patients define the rules for sharing
across organizations.
D
16HIPAA Security Rule key HIE elements
- Contingency management
- Availability of data in an HIE is critical and
especially difficult for federated model HIEs
(where the data is retained in the originating
organizations). So, contingency management at
provider sites (where the data will be until
requested) will be harder and more important.
D
17Other HIE-related laws
- NC State Law Notice of breach (NC ITPA 2005)
- This law would apply to breaches as part of the
typical HIEs operations. One would expect more
breaches in an active HIE. This applies to any
business or government agency in NC including ASP
EHR operations, web-based PHR operators, HIE
operators. - Other Special regulations covering drug and
alcohol treatment records, and mental health
records (42 CFR Part 2), Red Flags, FERPA - These laws apply to an HIE environment when the
contributing entities are covered. Observing each
law in an entity-oriented HIE environment will
require more work. Somewhat less work in a
person-oriented HIE (where the patient agent is
controlling the data.)
D
18A Sampling of HITECH provisions and their
Potential Effects on HIEs
19HITECH Act
- Changes to HIPAA
- Expanded Responsibilities and Liability for
Business Associates - Breach Notification
- Enforcement
- Penalties
- Restrictions
- Accounting of Disclosures
- Sale of PHI
- Meaningful use of EHR
- Will HITECH encourage or hinder the sharing of
electronic health information?
20Business Associates
- Definition of Business Associate (BA)
- A person who, on behalf of a Covered Entity
(CE) performs a function or activity involving
the use or disclosure of PHI (excluding members
of the CEs workforce). - Business Associate Agreement (BAA)
- Written contract with CE governing the use and
disclosure of PHI and protection of privacy
rights - Include certain specific provisions required
under HIPAA Privacy and Security Rules
21Business Associates
- Contractors or other non-workforce members doing
work for CE where work involves use/disclosure of
Protected Health Information (PHI) - A CE can be a business associate of another CE
- HITECH clarifies that organizations such as HIEs,
Regional Health Information Organizations (RHIO)
and eRx gateways that provide data transmission
of PHI, that require routine access to PHI are
BAs and must enter into BAAs with the CE -
22Expanded Role and Liability for Business
Associates
-
- Explanation Business Associate compliance with
BAAs become a direct requirement of HIPAA.
Expanded oversight role by Business Associates. - Effective date 2/17/2010
- Key Effects on HIEs Non-compliance may
constitute direct violation of HIPAA and BAA,
posing risk of double liability
23HIPAA Security Rule Compliance
- Explanation Today, BAs are contractually
responsible for compliance with the mini HIPAA
Security Rule. BAs become responsible for
complying with the full HIPAA Security Rule. - Effective date 2/17/2010
- Key Effects on HIEs All parties to HIE (covered
entities and business associates) may be bound by
the HIPAA Security Rule Standards (required or
addressable) - Administrative Safeguards
- Physical Safeguards
- Technical Safeguards
- HIPAA Security Rule organizational requirements,
policies, procedures and documentation
requirements
24Breach Notification
- Explanation Breach notification provisions apply
to CEs and BAs. CE obligation to notify each
individual whose unsecured PHI has been, or is
reasonably believed to have been, accessed,
acquired, used or disclosed as a result of the
breach. BAs required to notify CEs following BAs
discovery of a breach of unsecured PHI. - Key issues what constitutes a breach and
unsecured PHI - Effective date (already past) 9/23/2009
- Key Effects on HIEs Increased time spent by all
parties analyzing whether breach notice
obligation triggered and how to notify. - Upside for patient privacy
- Downside for compliance coordination among parties
25Breach Notification
- CE Notice Requirements
- Recipients
- Notify affected individuals whose PHI has been or
is reasonably believed to have been breached - Timing
- Without unreasonable delay, but in no event later
than 60 days following discovery (unless it would
impede a criminal investigation) - Content
- What happened
- Types of unsecured PHI
- What CE is doing to investigate the breach,
mitigate harm, protect against further breaches - Contact procedures for affected individuals,
including toll-free number, email address,
website or postal address
26Breach Notification under HITECH
- BA Notice Requirements
- Recipients
- Notify CE to which the breached information
relates - Timing
- Without unreasonable delay but no later than 60
days following the BAs discovery of the breach - Content
- Identify affected individuals to the extent
possible and other information available to BA
27Enforcement
- February 17, 2009 State attorneys general
authorized to bring civil actions to enforce
HIPAA violations - Attorneys general bringing civil actions under
HIPAA must give DHHS opportunity to intervene - February 17, 2010 HIPAA criminal enforcement
provisions apply to individuals - Criminal fines and jail time for intentional
violations - U.S. Department of Justice investigates and
prosecutes criminal violations - February 17, 2011 DHHS must formally investigate
complaints where preliminary investigation
indicates potential violation of HIPAA due to
willful neglect - Key Effects on HIEs Potential deterrent effect
on individual misconduct may lessen oversight
burden of entities participating in HIEs. On the
other hand, enforcement will increase, making
attention to compliance a priority.
28Greater Penalties
- Civil Penalties
- Previously, civil monetary penalties (CMPs)
limited to 100 per violation, not to exceed
25,000 for identical violations during a
calendar year - Key Effects on HIEs Money talks. These will
hit home for covered entities and business
associates participating in HIEs.
Violation categorySection 1176(a)(1) Each violation All such violations of an identical provision in a calendar year
(A) Did Not Know 100 50,000 1,500,000
(B) Reasonable Cause 1,000 50,000 1,500,000
(C)(i) Willful Neglect Corrected 10,000 50,000 1,500,000
(C)(i) Willful Neglect Not Corrected 50,000 1,500,000
29Self-pay episode disclosure restrictions -Section
13405(a).
- Explanation People who have health insurance
sometimes pay for care out of pocket in order to
protect their privacy. Some providers have had a
history of nonetheless reporting these self-pay
episodes to payers- thwarting that privacy need.
This new restriction requires covered entities
not to disclose data (electronic or paper) from
such self-pay episodes if a patient requests
this. - Effective date 2/17/2010 no regulations
- Likely key effects on providers
- Most providers wont change disclosure policy,
but will likely want to revisit how they document
and implement requests to restrict disclosures
(as required in the Privacy Rule) - For providers who allow access to records by
payer-based case managers (e.g. hospitals),
efforts will have to be made to segregate
self-pay data. - In EHRs, as data is reused in various functions,
segregation of self-pay data may be challenging.
(e.g. allergy data collected in a self-pay
episode) - Definition of episode of care will need
attention.
D
30Accounting of Treatment, Payment, Operations
(TPO) Electronic Disclosures- Section 13405(c )
- Explanation The HIPAA Privacy Rule has long
required that a list of non-TPO disclosures be
reported to the patient upon request (i.e.
provided date, recipient, content description,
purpose). The new requirement adds that all
electronic disclosures by EHR-using CEs and BAs
made for TPO purposes going back 3 years also be
reported to the patient upon request. Covered
Entities can either report for BAs or direct
patients to BAs for supplemental reports. - Effective Date For those who have an EHR on
1/1/09, accounting starts 1/1/2014 For those who
acquire EHR after 1/1/09, accounting starts
1/1/11 or when EHR is acquired, whichever is
later. HHS can delay a couple of years if
desired. Expect regulations 7/2010. - Likely key effects on providers
- e-TPO disclosures are common (e.g. to payers,
referrals) and will become much more common as
people approach meaningful use objectives. - Collecting the data may not be much of an
additional burden most CEs would want the log
of accounting data for their own use. - HHS will make regs on which data goes into the
accounting. (about 7/10) - BA Agreement and process adjustments. (Will you
do the accounting for BA work or will the BA?)
D
31Selling PHI - Section 13405(d )
- Explanation CEs and BAs who receive direct or
indirect remuneration for providing PHI to third
parties must have patient authorization (HIPAA
style). The issue being addressed with this
requirement is that the prior restrictions in
HIPAA on PHI sale were thought to still allow too
much sale of PHI outside of patient expectations.
CE/BA can receive remuneration disclosures for
public health (limited), research (limited),
treatment, CE sale to CE, payment of BA, patient.
Some HHS leeway to define other exceptions.) - Effective Date No later than 2/17/2011 HHS
regs by 8/17/2010, - Likely key effects on providers
- Most providers not affected
- Revisit of practices related to BAs, research,
public health.
D
32Patient right of electronic access to ePHI-
Section 13405(e)
- Explanation HIPAA Privacy Rule established a
federal right to patient access to PHI (the
designated record set) under virtually all
circumstances. This ARRA provision adds a right
for the patient to obtain an e-PHI copy from
EHR-using CE or direct that the CE transmit
e-PHI copy directly to patient-chosen entity or
person. (e.g. Send my ePHI to my PHR). CE
charges limited to labor costs. Note that this
right is separate from the meaningful use of EHR
objectives that require engaging patients and
families with HIT. - Effective Date No regs explicitly called for
No explicit date found likely 2/17/10 - Likely key effects on providers
- transmit may mean transmit- not hand a CD or
thumb drive copy. - Support extent for interfaces to recipients (e.g.
HealthVault, Google Health, iHealthRecord, Keas
and lots of others) not clear. - This requirement is a key incentive to use
patients as pivots for sharing data generally. - Potential for abuse e.g. marketers becoming
valid recipients without informed consent of
patient. - Identifying patients (e.g. keeping PHR
identifier)
D
33Meaningful use (MU) of EHR- Sec Medicare
4101(ambulatory), 4102 (hospitals), 4013,4104,
Medicaid 4201
- Explanation A large scale (17B, 600M in NC)
incentive program to encourage EHR/PHR usage.
Typical provider (e.g. physician, NP, PA) gets
45K-60K in form of Medicaid/Medicare bonus
reimbursement for 1)meaningful use of certified
EHR, 2) HIE, reporting on MU. 70 recommended
objectives spread over 5 years in these areas
Engaging patients and families (PHRs etc),
improving care coordination, ensuring adequate
privacy and security, improving population and
public health, improving quality, safety,
efficiency and reducing health disparities. - Effective Date Incentive payments are per year
with a lot of front loading starting in 2011 (to
2015). Some chance of penalties for non-MUser
Medicare providers after 2015. Draft regs
12/09. - Likely key effects on providers
- Serious money serious challenge Much more
electronic communication with patients. - Cant do it alone (especially the HIE part)
- Private payers will likely follow suit (i.e.
condition payment on EHR/PHR usage) - Very complicated careful planning required.
- Other programs (Regional Extension, State HIE
Collaborative, EHR loan) support.
D
34Risks of HIEs and Related HITECH Considerations
35HIE Challenges and Risks
- Maintaining Purity of Database Contents
- Integrity, right to use and disclose,
confidentiality - Multiple data sources
- Multiple party access
- Need to conduct data flow compliance analysis
- Ensuring appropriate BAAs are in place
- User education
36HIE Challenges and Risks
- HITECH
- Potential double jeopardy for BAs
- Increased operational duties and liability
exposure under a new, complex operational scheme - Risk of poisoning the well and using data
provided by third parties without proper
authorization
37Distribution of Security Risks
- The issue
- The typical provider focuses primarily on
security for its internal operations and
considers risk to itself. (e.g. risk of
inappropriate use/disclosure of PHI, uptime of
the system, local data integrity issues) - In an HIE security risks are distributed across
the HIE users. - The risk sharing model must satisfy each party
(e.g. hospital, physicians, payers, patients,
public health, researchers) or they wont
participate fully (or at least resist
participating). - Making security cost-benefit tradeoffs that
satisfy everyone in the sharing system is harder
than making tradeoffs that only have to satisfy
you. - Likely key impacts on providers
- Concerns about PHI confidentiality, integrity,
and availability will need to be revisited with
this new sharing model in which disclosures are
frequent and automatic. - Need for auditable standards in the HIE and at
the connected parties systems.
D
38Size and dynamism of the routine data sharing
community
- The issue
- Typical HIE will have a large and dynamic
community of information providers and
recipients. (e.g. hospitals, physicians,
patients, payers, researchers, public health). - Consider the challenge of managing registration,
authentication, access audits, and authorizations
among the members of this large and dynamic
group. - How will access changes be made when
practitioners are no longer eligible for access
(retired, quit, fired). How will changes in the
legal competence of individuals affect access? - Just to make things interesting you cant
depend on having a compulsory universal health
identifier. - Likely key impacts on providers
- There will be new external ids (of patients,
other providers) for each provider to keep and
use. - Providers will likely have to register/de-register
staff for access to external data.
D
39Use of comprehensive longitudinal patient record
(CLR)
- The issue
- Having all of the relevant historical data about
a person accessible for care, research, personal
use is the core attraction for an HIE. - But, having this CLR also raises the risk of
inappropriate disclosure. - Data shared via an HIE may be used over longer
times and for purposes not expected by the data
originator. The limits on time and usage today
help manage the risk of data being used for
purposes for which it is not suitable/permitted.
- Having the data in one place means that
availability depends on that place being up and
on being connected to the inquiring party. Having
data spread (as in a federated model) requires
that a lot of places be up at the same time to
satisfy some inquiries. - What happens when an HIE/storage facility goes
out of business? - Likely key impacts on providers
- Need to focus business process on dependence of
CLR availability - Need to determine medical/legal acceptability of
data.
D
40Changes in amount and effects of erroneous data
being shared.
- The issue Well functioning HIEs spread data
quickly whether it is true or not. Errors come
from two main sources - - Accident
- usually human error
- right data wrong patient mismatch is a typical
error (Factoid About .1 to 1 of patient record
selection operations that precede data entry
select the wrong patient) - Small environments (typical medical practice)
with a lot of context and personal knowledge of
patients help to keep this problem down. - -Fraud, Medical ID Theft
- To obtain services without paying
- To hide conditions
- To obtain money for services not rendered
- HINs will likely exacerbate the level of
erroneous data due to the relative distance
(in time, space, context) of the provider from
the user of the data. - Likely key impacts on providers
- Need to consider which data will be taken to be
actionable and which requires corroboration. - Need to consider how to inform the community when
previously shared data is found to be incorrect.
D
41Changing (HITECH and beyond) environment of laws,
standards, and regulations
- The issue
- . There is a large and growing set of public
policies (i.e. laws and regulations) related to
health information security and privacy. Notably,
enforcement of privacy and security measures was
strengthened in HITECH. - Generally they are meant
- to protect the person who is the subject of the
information from misuse of their information by
others (third party disclosure laws), - to help make amends if the information is
misused, and - to assure that the person has reasonable access
to the data. - There are also growing set of laws,
regulations, standards, and other incentives that
incite providers to engage in more routine
electronic information sharing. - Likely key impacts on providers
- They will more frequently have to actively manage
these risks and anticipate and respond to public
policy changes. - Providers may choose to bet that more consumer
protections/rights will emerge.
D
42Risks of failing to engage in routine information
exchange
- The issue
- Lets wait until the dust settles is a less
attractive option than it has been historically.
Waiting risks loss of incentive payments, penalty
impositions, various forms of non-compliance
actions or business disadvantages. - Likely key impacts on providers
- Providers will be less able to respond to privacy
and security issues in data sharing by not
sharing the data because of general concerns
about risk. - Waiting to pursue adopting the various privacy
and security elements in ARRA/HITECH has
significant risks.
D
43Approaches to Managing Risks in HIE
44Managing Risks of HIE Participation
- Fair Allocation of Risk under Data Access
Agreements - Cyber Insurance
- Different policy types
- Privacy liability coverage may cover damages and
claims related to privacy breaches, breaches of
specific privacy laws and regulations, such as
HIPAA. - Security liability coverage may cover damages and
claims arising out of computer attacks caused by
failures of security including theft of client
information, identify theft, negligent
transmission of computer viruses and denial of
service liability.
45Managing Risks of HIE Participation
- Relatively new type of insurance with potentially
high premiums application process for policies
may be long and detailed - Obtaining a policy when participating in HIE
- May be contractual requirement under HIE
participation agreement - May be a good business decision dependent on
type of system and risks of misuse or
unauthorized access - Potential Coverage Under Existing Policies
- Standalone cyber-insurance policy may not be
necessary. - Cyber-liability endorsement to a CGL or EO
policy may work
46Adjust existing security measures
- In anticipation of this new environment
- Review and update your HIPAA-required risk
analysis. - Likely key typical provider changes and tasks
- Review and update staff training on security,
sanction policy - Review and update your contingency plan
- Consider the reliability/capacity of your
broadband connection. - Assure unique accounts, robust passwords and no
account sharing - Note that affordable and useful insurance is
likely to require that you have a robust security
program. These requirements may affect your
security program. - Setup to capture, retain, and review access logs
start periodic reviews.
D
47Shifting/reducing risks
- In anticipation of this new environment
- Consider how risk (to PHI confidentiality,
availability, and integrity) are distributed
among you, your peers, BAs, patients in a routine
e-sharing environment. BAs are now covered
directly by ARRA explore how this shifts risks. - Likely key typical provider changes and tasks
- Consider HIE governance elements that affect risk
distribution. How will bad actors be managed?
What would happen if you were a bad actor? - Educate patients about their role in security
and where your role ends. - Consider cyber-insurance for some costs
associated with new risks (e.g. breach notice
costs). Recognize that affordable insurance will
likely come with obligations to run a secure
environment. - Consult your attorney about the shift in your
general business risk and malpractice risks.
D
48Collaborating with peers
- In anticipation of this new environment
- Determine who your key partners will be and how
to work with them in new or existing forums.
Make/adjust forums if needed. - Likely key typical provider changes and tasks
- Formulate projects in these forums that focus on
- Issues that require group consensus (e.g. HIE
governance issues) - Issues that are solved more easily via
group-generated information/support (e.g.
generation of check lists. Model RFPs, training
on security/privacy). - Consider how to minimize the time delay in action
normally associated with reaching consensus with
peers on an issue. - NC has many useful peer-based forums NCHICA,
CareShare, NCPHIT Committee, NCALHD, HWTFs HIT
Collaborative, others.
D
49Working with the public
- In anticipation of this new environment
- Determine when to approach your patients on this
change and via what means. - Likely key typical provider changes and tasks
- Aiding patients in understanding your data
sharing policies. - Helping patients understand how you share data
with them electronically and the best form of
partnership to make that sharing productive. - Prepare how you will interact with patients
about accounting of disclosure requests,
self-pay restriction requests, providing e-copies
of various PHI collections, notice of breach.
D
50Online Resources
- Key HHS web site
- http//healthit.hhs.gov - see, especially,
links labeled Meaningful Use - for a list of
the meaningful use objectives recommendations. - Privacy and Security - for key documents
related to HITECH and HIPAA PS elements. - NCHICA
- httpwww.nchica.org - links to tools and
collaboration opportunities. - HIPAA FAQs
- http//www.hhs.gov/ocr/privacy/hipaa/faq/index.ht
ml - question and answer format
51- Questions Answers
-
- Un-mute press 7
- Mute press 6
- Name
- Type of Organization
- (free clinic, hospital, health center,)
- County
- Be brief
52Contact Information
- Alicia A. Gilleskie
- Smith, Anderson, Blount, Dorsett,
- Mitchell Jernigan, LLP
- 919-821-6741
- agilleskie_at_smithlaw.com
Dave Kirby Kirby Information Management
Consulting, LLC
919-272-1157 Dave_at_KirbyIMC.com
mdarrow_at_CareShareHealth.org Care Share Health
Alliance www.CareShareHealth.org 919-861-8355