Transcript DirectTrust HISP Operations Policy Jan 16 2014

HISP Policy “HP” 1.0 Overview
Policy Document available at DirectTrust.Org
Presented by: Luis C. Maas III, MD, PhD
Direct Project Connect-a-thon
January 16, 2014
www.DirectTrust.org
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Why DirectTrust Accreditation?
• Direct Messaging depends on trusted
counterparties
– By design, can only exchange with trusted Direct
addresses
– Market demands accredited HISPs, for confidence in
exchange
– Building pairwise contracts will not scale: a common
set of requirements, signified by inclusion in a bundle
of trusted anchors, is the most efficient way to grow
interoperability
DirectTrust Network
www.DirectTrust.org
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DirectTrust Accreditation: What is it?
• HISP accreditation demonstrates compliance with:
– Direct Project Applicability Statement
– HIPAA and HITECH, and all other federal and state laws
• Software management practices of HIPAA/HITECH apply to every
HISP
• How PHI may be used is specified in every HISP’s own legal
agreements with end users
– Secure management of customers’ personal information
• For Certificate Authority and Registration Authority
accreditation, existing active versions of DirectTrust
Certificate Policy demand secure, industry standard
practices of CAs/RAs
www.DirectTrust.org
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Purpose of DirectTrust HISP
Accreditation
• Set the minimum bar for HISP privacy and
security, for the benefit of HISP end users +
data exchange partners
• The added confidence in Direct exchange is
expected to allow for rapid network growth
from today’s DirectTrust Network of 14 HISPs:
www.DirectTrust.org
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To The Nearly-Doubled DirectTrust Network expected in
Q2, 2014:
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& Likely DirectTrust Network in 2015:
www.DirectTrust.org
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Goals of the HP
• Clearly define the systems within a business
constituting HISP services
• Establish the “measuring stick”: minimum
administrative & technical requirements for
Health Information Service Providers (HISPs) with
regard to message and credential management
and authentication to the system
• v1.0 of HP = current accreditation requirements
(one exception noted later)
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HISP Definition-1
• Direct Services cannot exist without a HISP
• ALWAYS part of HISP:
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STA functions
Trust management
Certificate discovery
S/MIME interfaces
HISP side of edge protocol
End User private key stores
End User authentication
Maintain integrity of framework, ISSO functions
www.DirectTrust.org
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HISP Definition-2
• SOMETIMES part of HISP:
– Provision Direct Addresses
– Generate End User private keys
– Operate SMTP server and/or POP/IMAP server
– Operate DNS and/or LDAP for certificate discovery
– Maintain End User message queues/mailboxes
– Tools to create Direct message
– Technical support
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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HISP Definition-3
• OUTSIDE the HISP/not in scope of HP:
– CA and RA roles (covered in DirectTrust Certificate
Policy)
– Store/analyze EHR/PHR data
– Other EHR functions
– CDA processing/validation
– Provider Directory
– Use of Direct credentials for other purposes
www.DirectTrust.org
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Classification of Direct Entities
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Covered Entity (CE)
Business Associate (BA)
Healthcare Entity (HE)
Patient
All four entities adhere to same HISP
requirements, except Patient HISPs write data
privacy policies rather than using BAA terms
www.DirectTrust.org
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Outside HISP
Boundary
1.
2.
HISP, Edge &
User
Mailboxes
Direct
Messages
HIPAA/HITECH (& other laws’) compliance by Direct entities governs privacy and
security outside HISP boundary; this is outside the scope of DirectTrust
DirectTrust HISP Policy sets privacy and security requirements at edge and for
access to user mailboxes via HIPAA/HITECH and other requirements
– BAA in each HISP’s agreement describes HISP’s permitted use of PHI
– Privacy Policies describe each Patient HISP’s permitted use of PHI
– One of the above is required by DirectTrust, as appropriate
3.
DirectTrust HISP Policy sets privacy and security requirements of message data
via Direct Project and other requirements
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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Direct Exchange Counterparties, via SMTP
Privacy & Security Summary
Privacy & Security Summary
• Other data usage & processing outside scope
of DirectTrust policies, but policy opinions are
under development relating to:
– Directories & Personal Information (Direct
Directory Policy WG)
– Patient HISPs (Patient & Consumer Participation
WG)
www.DirectTrust.org
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HISP Policy Requirements: Overview
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Infrastructure
Data Privacy Policies
Certificates
Private Keys
Physical Controls
Software Controls & Processes
Software Development Process
Direct Project
www.DirectTrust.org
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There’s More…
• Today’s overview covers the “MUST”
requirements of the HISP Policy
• Many additional “SHOULDs”,
recommendations, and Practice Notes not
covered today
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Requirements: Infrastructure
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System diagram of essential HISP sites
List of all hardware and software used w/ PHI
Possess adequate physical resources
Effective controls and procedures against
malicious software
• Protection of internal databases, web servers
• Access controls on repositories
www.DirectTrust.org
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Requirements: Data Privacy Policies
• Have contracts with customers that contain
terms of BAAs when required by law, e.g. for
every organization bound by HIPAA
• For non-Covered Entity customers, publish a
privacy policy regarding authorized and
unauthorized use of customer PHI,
subcontractor terms, and PHI disposition on
termination
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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Requirements: Certificates
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Certificates conform to DirectTrust CP
Ensure certificates in DNS or LDAP for discovery
Protect private keys and use as certificate permits
Guidelines for determining certificate revocation
status—CRL required, OCSP optional
• HISP must request revocation if compromise of
End User keys suspected
• Perform CA and RA roles or use an accredited CA
and RA
www.DirectTrust.org
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Requirements: Private Keys
• Perform private key risk assessment &
mitigation
• ISSO ensures protection of keys & access lists
• Document how different LoAs supported;
operate all infrastructure at highest LoA
supported
• Hardware & software storing end user private
keys must be well protected
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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Requirements: Physical Controls
• Protect equipment from unauthorized access
• Only authorized HISP personnel may access equipment
• Implement & document procedures limiting access to
facilities, including role-based access to software
• Document physical modifications to facilities that
impact security
• Audit trail on equipment containing PHI
• Policies & procedures for final disposition of PHI and
hardware/media/paper on which stored
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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Requirements: Software Controls &
Processes-1
• Multiple roles are defined so that malicious activity
requires multiple parties’ involvement; must have staff to
fill all roles and ensure relevant training—at minimum
annually for those with access to PHI
• Maintain user access list to PHI
• Policies & procedures ensuring HIPAA compliance, federal,
& state laws, archived 6 years
• Authenticate End Users and intermediate systems at LoA of
HISP infrastructure
• Policies restricting personal, unlicensed, unapproved
software
• Documented policies for workstations that may access PHI
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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Requirements: Software Controls &
Processes-2
• HISP employees, persons, software programs may
access PHI only as needed, based on procedure
used to determine initiation & termination of this
purpose; policies must prevent unauthorized
access by those without purpose
• Procedures to document, review, modify user
access to workstation, transaction, program, or
process
• Unique user identities for system access
• Inactivity timeouts
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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Requirements: Software Controls &
Processes-3
• Hybrid entities must protect PHI in healthcare
component from other components of org.
• Hybrid entities must document healthcare
component
• Sanctions within HISP for non-compliance
with security policies
• BAAs are required of HISP contractors
handling PHI; several specific stipulations
www.DirectTrust.org
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Requirements: Software Controls &
Processes-4
• Audit logs relating to security of HISP are made
available during compliance audits
• PHI risk assessment must be performed
• Quarterly internal vulnerability assessment with
improvement process; annually by 3rd party
• Maintain written records of actions required by law for
6 years
• Procedures to respond to & document actual or
suspected security issues
• Written disaster recovery policy
• Annual criticality analysis of contingency plan
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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Requirements: Software Controls &
Processes-5
• Security & breach notification procedures
• Procedure for secure facility access for data restoration &
access to PHI during emergency
• PHI backup, if PHI is stored; additionally before equipment
moved
• Configuration standards of systems involving PHI &
workstations that access those systems
• No unencrypted PHI on PCs, consumer devices, or
removable media
• Appropriate security for wireless networks
• Firewall configured to protect system integrity
• Monitored/blocked & alarmed intrusion detection
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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Requirements: Software
Development Process
• Documented software development policies
• Formal change management framework
• Have a process to evaluate and respond to
new state and federal regulations
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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HISP Policy Requirements: Direct-1
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Message integrity checking
Messages protected by HIPAA privacy rules
SSL/TLS or equivalent edge encryption
Documentation of message access methods
Deliver messages without diverting or
redistributing except for backup or as required
by regulations
• Handling of untrusted messages
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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HISP Policy Requirements: Direct-2
• Document how trust can be configured for customers
• Perform authentication, encryption, trust verification,
and acknowledgement of responsibility to deliver
messages using SMTP as in the Applicability Statement
• Support DNS and LDAP for certificate discovery
• Perform STA functions per Applicability Statement and
Certificate Discovery for Direct Project IG
• If one way trust is enabled for send or receive, must be
able to receive or transmit MDNs with counterparty
• Counterparty HISPs may not be charged to exchange
messages with end users
www.DirectTrust.org
1101 Connecticut Ave NW, Washington, DC 20036
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HISP Policy Requirements: Direct-3
• MDNs:
– 1 hour response time for Processed/Dispatched
else Fail recommended
– Interoperability Note: Dispatched
• New requirement not in v 1.0 DTAAP criteria
and not in 2014 MU2 criteria:
– Messages must be sent wrapped and HISPs must
be capable of receiving wrapped messages
www.DirectTrust.org
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HISP Policy Q&A
• DirectTrust Security & Trust Compliance
workgroup meets on Wednesdays at Noon
PST
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