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Simplify...Simplify...Simplify...Simplify...Simplif n Administrative Simplification Administrative Simp Health Data Standards and Health Information Privacy The Health Insurance Portability and Accountability Act of 1996 Title II - Subtitle F Administrative Simplification

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Page 1: Simplify...Simplify...Simplify...Simplify...Simplify...Simplify...Simplify e ification Administrative Simplification Administrative Simplification Health

Simplify...Simplify...Simplify...Simplify...Simplify...Simplify...Simplifye ification Administrative Simplification Administrative Simplification

Health Data Standards

and Health Information Privacy

The Health Insurance Portability and Accountability Act of 1996

Title II - Subtitle F

Administrative Simplification

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Improve the efficiency and effectiveness of the health care system, by standardizing the electronic transmission of certain administrative and financial transactions

Protect the security and privacy of health information

Purpose of Provisions

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Overview of Provisions Secretary of HHS must adopt standards for

electronic health care transactions, unique health identifiers, code sets, security, and privacy

All health plans, clearinghouses, and those providers who choose to conduct these transactions electronically are required to implement these standards

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Overview of Provisions Supersedes most contrary provisions of

state laws

Expands the scope and membership of the National Committee on Vital and Health Statistics

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Overview of Provisions Civil and criminal penalties are prescribed for

failure to use standards or for wrongful disclosure of confidential information

– Penalties of $100 per violation of standards (up to $25,000 total per year per standard)

– Penalties of $50,000 to $250,000 and 1 to 10 years in jail for wrongful disclosure of individually identifiable health information

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Transaction Standards Claims or equivalent encounter information

Coordination of benefits information

Referral certification and authorization

Enrollment & disenrollment in a health plan

Eligibility for a health plan

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Transaction Standards Health care payment & remittance advice

Health plan premium payments

First report of injury

Health claims status

Health claims attachments

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Supporting Standards Unique identifiers (including allowed uses) for:

– Individuals– Employers– Health Plans– Health Care Providers

Code sets (including issues of maintenance)

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Supporting Standards Security (including electronic signatures),

confidentiality, and privacy

Low cost distribution mechanism

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Implementation Timeline

HHS adoptstransaction stds.(excl. claims)

HHS adoptsclaims stds.

HHS reviews/modifies first stds.

Plans, clearinghousesand providers adoptstds.

NCVHS recommendsstds. and legislation forelectronic exchange ofmedical records

Small plansadopt stds.

August February February August February August February1997 1998 1999 2000 2001

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Standards Adoption Process In general, any standard adopted shall be a

standard that has been developed, adopted or modified by an ANSI accredited standards setting organization (SDO)

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Standards Adoption Process The Secretary may adopt a different

standard if:

– it will significantly reduce administrative costs compared to alternatives, and it is promulgated in accordance with “negotiated rulemaking” procedures, or

– No SDO has developed, adopted or modified a standard in that area

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Standards Adoption Process A standard may not be adopted unless the SDO has consulted

with:– NUBC– NUCC– WEDI– ADA

In adopting standards, the Secretary will rely upon the recommendations of the NCVHS and the HHS Data Council

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Implementation Strategy HHS will utilize a three tier approach to

implementation

– HHS Data Council will provide senior level policy guidance and decision making and will serve as the contact point for the NCVHS

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Implementation Strategy– The Data Council’s Health Data Standards

Committee will be responsible for the daily operation and management of the standards activities

– Implementation Teams will be responsible for the research, analysis, and development of mandated national standards

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Implementation Teams HHS has established six internal

interdepartmental implementation teams to identify and assess potential standards

– Infrastructure and cross-cutting issues

– Health insurance claims and encounters

– Health insurance enrollment and eligibility

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Implementation Teams

– Health identifiers for providers, health plans, employers and individuals

– Code sets and classification systems

– Security and safeguards

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Team Approach Identify existing candidate standards for

each area, identify gaps and conflicts, and present findings to NCVHS and HHS

Develop recommendations for standards to be adopted and present to NCVHS & HHS

Submit draft regulations to the Secretary and to OMB for initial review

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Team Approach Publish proposed rules in Federal Register for

public comment

Analyze comments and prepare and publish Final Rules

Distribute adopted standards and implementation guides

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Privacy Goals Provide patient rights

– Informed consent to release information

– Access to own health information

– Ability to correct erroreous entries Establish process for exceptions

– Research, Law Enforcement, Public Health Limit amount of information and access Establish deterrents and penalties

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Privacy Timeline

HHS privacyrecommendations

Privacy legislation

If no privacy legislation,HHS privacy regulations

August February February August February August February1997 1998 1999 2000 2001

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Opportunities for Input Participate with standards development

organizations

Provide testimony at NCVHS public hearings

Provide written input to NCVHS

Provide written input to the Secretary of HHS

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Opportunities for Input Comment on the Federal Register

publications for each proposed standard

Invite Implementation Teams staff to meetings with public and private sector organizations

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National Committee on Vital

and Health Statistics

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New NCVHS Responsibilities Membership increased from 16 to 18 with

two members appointed by Congress

Annual report to Congress on HIPAA implementation status

Serve as a public forum for all interested parties and provide mechanisms for public input through hearings and meetings

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New NCVHS Responsibilities Assistance to Secretary:

– Standards - Secretary to rely on the recommendations of NCVHS and publish recommendations in Federal Register

– Privacy & Confidentiality - Secretary to consult with NCVHS on legislative privacy recommendations

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New NCVHS Responsibilities– Report to Secretary within 4 years with

recommendations and legislative proposals on standards for computerized patient record

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Current NCVHS Activities Full Committee meetings quarterly

Subcommittee on Privacy and Confidentiality

Subcommittee on Health Data Needs, Standards and Security

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Sources of Information HHS Data Council Web Site

– http://aspe.hhs.gov/datacncl/

NCVHS Web Site

– http://aspe.hhs.gov/ncvhs/

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Cross-Cutting Implementation Issues

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Purpose– Provide overall guidance and coordination to the

HIPAA EDI standards Implementation Teams– Track progress of the HIPAA EDI standards

project– Serve as the information point for overall HIPAA

EDI standards implementation information.

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Charge Responsibilities

– Develop and maintain master data dictionary and data structures list for all standards

– Develop a timeline for the entire project– Provide periodic progress reports on the project to

HHS and the NCVHS– Monitor progress of individual implementation

teams

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Charge

Responsibilities cont.– Provide guidance and coordination on common

issues (e.g. regulation development)– Facilitate communciation among implementation

teams– Serve as communication point between

implementation teams and HHS Data Council.– Assure all implementation teams have common

understanding of issues

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Guiding PrinciplesImprove efficiency and effectiveness of

systemMeet the needs of usersBe consistent with other administrative

simplification standardsHave low implementation costsBe supported by a SDO

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Guiding PrinciplesHave timely adoption proceduresBe technologically independent of platformsBe precise & unambiguous, but as simple as

possibleKeep data & paperwork burdens lowHave flexibility to adopt to health system

changes

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Barriers Barriers to adopting national uniform standards:

– Conflicting standards; e.g., ANSI vs. industry vs. government

– Conflicting implementations; e.g., proprietary collection of unique or differently defined data

– Incomplete standards; e.g., no implementation guide

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Barriers More barriers:

– Proprietary code sets; e.g., professional associations make $ selling code sets

– Cost of change; e.g., cost of changing length of ID– Privacy; e.g., potential use of SSN as unique ID

raises fear of easier access and linkage of confidential information

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Frequently Asked Questions

Is Big Brother forcing this on the industry? Will only providers benefit from HIPAA

standards? Is DHHS doing this alone? Will DHHS merely adopt Medicare

standards? Will all HIPAA standards be adopted in 18

months?

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Frequently Asked Questions

Will private sector standards be adopted with no change?

Which HIPAA standards will be adopted first?

Will HIPAA standards be tested?

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Issues

Conformance testing– Who does it– Who pays for it– Who monitors the testers

Data dictionary/Implementation guides– Who maintains them– Who pays for them

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Issues

Timely updates to “Final Rule”– How do we keep standards up with

developments How do we draw the lines between

employers, plans, and providers Timing

– Is 2 years enough time– Is February, 2000 the safest time to comply

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Issues

Are the teeth big enough– Some have indicated it would be cheaper to pay

the fines initially– If Medicare/Medicaid implements it, is that

enough to move industry

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Current Activities

Master data dictionary– over 4700 elements included to date

Draft ‘boilerplate’ regulation language Cross-cutting implementation issues

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Claims and Encounters Implementation Team

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Charter

Adopt formats and data content for:

– Health insurance claims, encounters, COB

– Remittance advice

– Claim status inquiry

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Charter

Facilitate identical implementations through:

– Implementation guides

– With precise instructions on data content

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Process

Created information structure Solicited formal advice

– National Uniform Billing Committee– National Uniform Claim Committee– Workgroup for Electronic Data Interchange– American Dental Association

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Principles

Data Content Management Structural Stability Reliability Documentation

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Principles

Data Content Management – Data update timeliness– Implementation guide update

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Principles

Structural Stability– 3 years– One structure– Annual data updates

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Principles

Reliability

– Testing part of the process– Results made public– For claims, encounter, COB - pilot

production required

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Principles Documentation

Complete and unambiguous– Implementation guide– Data dictionary– Data conditions

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Principles

Each transparent to the other, i.e., common/like data will be found in the same location

– Claim

– Encounter

– Coordination of Benefits

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Recommendations

Retail Pharmacy Claim - NCPDP v. 3.2 Remittance Advice - X12.835 v. 3070 Claims Status - X12.277 v. 3070 Dental Claims - X12.837 v. 3070 Physician/Supplier Claims - X12.837 v.

3070 Institutional Claims - X12.837 v. 3070

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Data Content

Working with base sets Working with organizations Superset concept

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Issues

Divided opinions– Institutional and physician/supplier

claims/encounters/coordination of benefits

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Unique Health Identifiers Implementation Team

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Charge

Recommend Standard Unique Health Identifiers (including allowed uses)

– Individual

– Employer

– Health plan

– Health Care Provider

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Individual Identifier

Current Activities– Analysis of proposals in ANSI/HISB inventory– Use of criteria from American Society for Testing

and Materials Standard Guide for Properties of a Universal Health Care Identifier

– Evaluation of SSN by SSA– Evaluation of Postal Service as Trusted Authority

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Individual Identifier

Current Thinking--Eliminate consideration of– Unenhanced, unverified SSN– Biometric identifier proposals– Identifier based on existing medical record

number plus practitioner prefix

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Individual Identifier

Current Thinking--Continue consideration as identifiers– Enhanced SSN, as proposed by the Computer-

based Patient Record Institute– Identifier based on personal immutable properties– Universal Health Care Identifier (UHID), as

described in ASTM Guide

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Individual Identifier

Current Thinking--Continue consideration as supporting technologies– Directory service, or master patient index– Public/private key encryption

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Individual Identifier

Issues– Risks, limitations of SSN as a health identifier– Insufficient documentation of infrastructure for

other proposals– Adequacy of current technology to support

national master patient index (MPI) or public/private encryption

– Acceptance by public of a national MPI or national health identifier

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Individual Identifier

Issues– Method to positively link individual to his/her

identifier– Method to prevent issuance of duplicate

identifiers – Medical record linkage vs right to anonymous

care– Costly infrastructure investment likely– Controversy with any recommendation

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Employer Identifier

Current Activities– Coordination with Enrollment/Disenrollment,

First Report of Injury, Premium Payment transactions

Current Thinking– Recommendation of Employer Identification

Number (EIN)

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Employer Identifier

Issues– EIN is not unique to the employer--Is this a

problem for health transactions?– Some sole proprietors do not have an EIN--

Would they be required to obtain an EIN for health transactions?

– Would health transaction uses of EIN require legislative or regulatory change?

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Health Plan Identifier

Current Activities--PAYERID to be proposed– 9-position numeric, including 1 check digit– No intelligence in number– Can enumerate 100 million health plans and

employers that offer funded and unfunded health benefits

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Health Plan Identifier

PAYERID System Features– Registry of business information about the

entity– Electronic “phone book” containing names of

entities and their PAYERIDs– Data base of information needed to route health

care transactions electronically Issue--High-level vs detailed enumeration

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Provider Identifier

Current Activities--National Provider Identifier (NPI) to be proposed– 8-position alphanumeric, including 1 check

digit– No intelligence in number– Can enumerate 20+ billion providers

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Provider Identifier

System Features– Data validation (SSN, address,etc.)– Search/match for duplicate providers– Query/report generation--national data base

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Provider Identifier

Issues

– Enumeration options

– Provider practice addresses and location codes

– DHHS OIG Sanction Data

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Enrollment and Eligibility Implementation Team

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7

Charge

Standards and implementation guides for the following transactions

– Enrollment

– Eligibility

– First Report of Injury

– Health Plan Premium Payments

– Referral Certification and Authorization

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Recommendations

Enrollment - X12.834 1st Report of Injury - X12.148 Premium Billing and Payment -

X12.811/820 Health Care Services Review - X12.278 Eligibility - X12.270/271

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Enrollment

Current Implementation Guide Covers Forms of Benefits

Narrower scope for a health care-specific guide Policy: Are standards imposed by OMB

Directive 15 applicable to HIPAA? Are performance measurement and outcome

research needs covered by HIPAA?

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1st Report of Injury

No Current Implementation Guide Not health care-specific transaction guide:

outside HHS purview DoL - OSHA, BLS, OWCP Policy: Expand to allow physician first

report? May have to engage private sector “workers

comp” community

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Premium Billing & Payment Used in Industry as ANSI finance function No Implementation Guide HIPAA Use Not Very Complicated

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Health Care Services Review

Multiple Implementation Guides Possible Limited, If Any, Actual Use Pilot Project Underway May be a late deliverable for 2/98

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Eligibility

Mapping Government data element Requirements

All necessary components in place to produce the regulation

Not doing interactive Eligibility Transactions

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7

Data Dictionary

Includes

– Listing of names, definitions, transactions and locations

– Organized by individual transactions Does NOT include

– Code values

– Implementation instructions

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Coding and Classification Implementation Team

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Charge

Codes and classification– Diseases, injuries, impairments, other health

problems– Causes of these conditions– Actions taken to prevent, diagnose, treat or

manage these conditions» including substances, equipment, and supplies

used

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Charge

Responsibilities– Select standards for codes/classifications for

administrative transactions and ensure appropriate mechanisms for distribution and maintenance

– Recommend set of health vocabularies for full electronic health records and ensure appropriate mechanisms for distribution and maintenance

– Map vocabularies to administrative codes/classifications

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Recommendations - 2000

Diseases, injuries, impairments, etc.– ICD-9-CM

Procedures– ICD-9-CM– CPT– CDT– HCPCS (encompasses CPT and CDT)

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Recommendations - 2000

Drugs– For most administrative transactions

» HCPCS– For pharmacy transactions

» NDC Devices

– HCPCS

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Issues

Use of official implementation guidelines Likelihood of changes in some standards

for 2001 and beyond– e.g., move to ICD-10-CM

Need to have ability to accept codes and identifiers > 5 characters in 2001 and beyond

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Issues

Openess of update process for privately owned and maintained systems

Cost and use restrictions for privately owned and maintained systems

Availability of electronic formats suitable for full range of users

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Security Standards Implementation Team

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Charge Security of Healthcare Systems/Transactions Electronic Signatures

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Objectives

Establish a Healthcare Data/Systems Security Framework

– e.g., NRC Report Identify Requirements “Baseline” Technology Neutral -- if possible

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Scope of Work Defined Transactions Only, however ... Key Considerations (in act)

– tech cap of rec systems– costs– training, personnel issues– value of audit trails– needs and capabilities of small hc providers and rural

hc providers Security, not Privacy

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Definitions Privacy vs.Confidentiality vs Security Security

– Confidentiality– Integrity– Availability

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Definitions Security Mechanisms

– Identification– Authentication– Authorization– Access Controls– Audit/Accountabilty

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Requirements Analysis Underlying Requirements

– Interoperability System Model / Matrix Baseline Security Requirements Potentially Conflicting Requirements

– Other Groups’ Work (e.g., Privacy, Transaction Sets, etc.)

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Issues Level of detail/specificity of published

“standards” Determining needs/constraints of “Small”

players