1 hipaa: privacy regulations addressing hipaa at harvard university tina s. sheldon harvard...

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1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge, Massachusetts August 19-23, 2002

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Page 1: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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HIPAA: Privacy Regulations Addressing HIPAA at Harvard University

Tina S. SheldonHarvard University

HIPAA Colloquium at Harvard UniversityCambridge, Massachusetts

August 19-23, 2002

Page 2: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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Agenda

Inside Harvard Yard

HIPAA’s Impact on Harvard

Harvard’s Approach to HIPAA

HIPAA Issues & Operational Concerns

Page 3: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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Inside Harvard Yard

Decentralized Structure

HIPAA Coordinators’ Role

Communication & the Governing Body

University-wide Partnerships

Page 4: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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HIPAA’s Impact on Harvard

Inventoried PHI on Campus

Identified Covered Components

Reviewed Non-Covered Components

Examined Statutory Exceptions

Page 5: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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PHI on Campus

University Health Services

Dental School Dental Clinics

Mental Health Services (Schools)

Student Athletics

Faculty & Staff Assistance Program

University Group Health Plan

Medical Flexible Spending Account Plan

Workers’ Compensation

Disability Plan

Research with Human Subjects

Page 6: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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Covered Components

Health Care Providers University Health Services Dental School Dental Clinics

Health Plan University Group Health Plan Medical Flexible Spending Account Plan

Health Care Clearinghouse None

Page 7: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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Non-Covered Components

Mental Health Services Student Services: Records

Protected by FERPA

Student Athletics Student Services: Records

Protected by FERPA

Faculty & Staff Assistance Referral Service, No

Records, No Billing

Workers’ Compensation Self-Insured, Self-

Managed: State Preemption

Disability Programs Self-Insured, Self-

Managed: State Preemption

Research with Human Subjects IRB Approval Process

Page 8: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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Bifurcated Approach: Health Care

Constituents University Health Services University Group Health Plan Dental School Dental Clinics Human Resources: Benefits Group

Sponsored Training HIPAA Tutorial: McDermott, Will & Emery

Convened HIPAA Work Group: Multi-Disciplinary Assess Records & Business Practices Inventory Vendors & Write Agreements Write Notice, Forms & Policies Train Clinical & Administrative Staff

Page 9: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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Bifurcated Approach: Research

Constituents Institutional Review Boards Office of Sponsored Research Principal Investigators

Sponsored Training HIPAA Workshop: McDermott, Will & Emery Case Study Discussion & Analysis

Created HIPAA Research Brochure

Charged IRB Operations Group IRB Administrators Office of Sponsored Research Office of General Counsel Risk Management & Audit Services

Page 10: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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HIPAA Issues & Operational Concerns

Hybrid Organization Primary Function: Education & Research Designate Health Care Components Document Designation: Corporate Vote

Privacy Officer Each Covered Component will Designate Privacy Officer Each Privacy Officer will have Access to Governing Body

Student Services FERPA vs. HIPAA Transfer Issue: EMTALA Consent Issue: Freshman Physicals

Page 11: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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HIPAA Issues & Operational Concerns

Dental School Dental Clinics: Faculty & Teaching Practice Dental Students: HIPAA Training? Dental Students: Dental Records? Dental School Graduates: Board Certification? Volunteer Teaching Faculty: How HIPAA Wise?

Research with Human Subjects: 3 IRBs: Different Types of Studies & Data Points Longitudinal Studies: Study Drop-outs & Aggregated Database? PI Status: Covered Entity? PI Request: Further Analysis of Data? Colleague Request: Comparative Use of Data?

Page 12: 1 HIPAA: Privacy Regulations Addressing HIPAA at Harvard University Tina S. Sheldon Harvard University HIPAA Colloquium at Harvard University Cambridge,

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Closing Comments

Look to Trade Associations & Industry Groups

Create HIPAA Academic & Medical Networks

Collaborate & Establish Community Best Practices

Document HIPAA Resources & Expenses