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ROWAN

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UNIVERSITY POLICY


Title:

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 Disclosures of Personally Identifiable Health Information to Business Associates
Subject:

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 Office of Compliance & Corporate Integrity (OCCI)
Policy No:

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 OCCI: 2013: P08
Applies:

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 RowanSOM
Issuing Authority:

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 Rowan President & RowanSOM Dean
Responsible Authority:

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 RowanSOM Chief Compliance and Privacy Officer & Rowan Security Officer
Adopted:

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 04/14

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/2003
Amended:

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 07/01/2013.
Reviewed:

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12/30

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/2014

I.      PURPOSE

To assure compliance with the requirements of the Health Insurance Portability and Accountability Act (HIPAA) of 2004, Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 and the Omnibus Privacy Final Rule of 2013 in relation to disclosures of Protected Health Information (PHI) and to entering into contracts with business associates.

II.     ACCOUNTABILITY

Under the direction of the President, the Deans, Executive Vice President for Administration and Strategic Planning, Executive Vice President for Academic and Clinical Affairs, Chief Compliance and Privacy Officer, Vice President for Finance and CFO and General Counsel shall ensure compliance with this policy.

III.    APPLICABILITY

This policy shall apply to disclosures to business associates of health information that is generated during provisions of health care to patients in any of the RowanSOM's patient care units, patient care centers of faculty practices as well as Human Subjects research under the auspices of RowanSOM or by any of its agents in all RowanSOM, Units, Departments and University owned or operated facilities.

IV.    DEFINITIONS

A. "Protected Health Information (PHI)" - Protected health information means individually identifiable health information that relates to the past, present or future physical or mental health or condition of an individual, the provision of health care to an individual or the past, present or future payment for the provision of health care to an individual and identifies or could reasonably be used to identify the individual. PHI of a decedent, who has been deceased for more than 50 years, is no longer considered protected PHI [160.103 and 164.502(f)].

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D. "HITECT ACT" - Section 13402 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA) that was enacted on February 17, 2009.

V.    REFERENCES

A. 45 CFR 160.103(a), Code of Federal Regulations, Title 45, Part 164, Section 103, Subpart A, General Administrative Requirements, General Provisions, Definitions

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 I.  Standards for Privacy of Individually Identifiable Health Information

VI.   POLICY

A. Requirements:

  1. RowanSOM and/or its units may only allow an individual or entity that is not part of its workforce that provides certain services to RowanSOM and/or its units, or performs a function or activity on its behalf, to create or receive PHI without an authorization if the individual or entity:
    1. meets the definition of a business associate as described above, and
    2. enter into a written business associate contract with RowanSOM that meets the elements in 45 CFR 164.504(e) with RowanSOM.
  2. To determine whether the person or entity is required to enter into a business associate contract, use the following guidelines with the attached flowchart (EXHIBIT A):
    1. No contract is needed with members of the workforce as defined in the definition. An independent contractor may be considered a member of the workforce if RowanSOM exercises supervision and control over the person as it would if the independent contractor was an employee.
    2. A contract is necessary with persons who meet the definition of a business associate. (Since business associates access PHI without obtaining authorizations from the individuals to whom the PHI pertain, it is important that units do not inappropriately classify a person as a business associate and therefore fail to obtain the required authorization).
      1. A business associate is someone who does the following:
        1. Performs or assists in the performance of a function or activity on behalf of RowanSOM and/or its units including claims processing or administration, data analysis, processing or administration, utilization review, quality assurance, billing, benefit management, practice management, re-pricing, and any other function regulated by 45 CFR 164.504.

          For examples see EXHIBIT B for a list of specific types of persons, entities, and services that may qualify as a business associate provided that they meet all the elements discussed in this policy and procedure (i.e. the person will perform a function on behalf of RowanSOM that is not for the purposes of treatment only, etc).
        2. Provides legal, auditing, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation, paper recycling, shredder companies, transcription services, record copy services, offsite storage, information technology (IT) services where confidentiality, integrity or availability of ePHI is at risk, including software/hardware support of computing medical devices, and/or application services such email, web or database services or financial services for Rowan University.
      2. Researchers - This is not a covered function for purposes of a business associate contract.
      3. Financial Transactions - No business associate agreement is required with a financial institution if it only processes consumer-conducted financial transactions in payment for health care.

        For example, a bank that processes credit or debit card transactions or clears checks for a hospital would not be considered a business associate. Although some PHI of the patient is disclosed to a financial institution in this example, such as the patient's identity and perhaps some health information (e.g., the procedure performed), these facts do not create a business associate relationship because the bank is not acting on behalf of the hospital in performing its functions. The hospital is not in the business of directly processing credit card transactions or cashing checks.
    3. No contract is needed when the person or entity's function or service does not involve the use and disclosure of PHI, and where access to PHI by such persons would be de minimus or incidental, if at all.

      For example, it is not required that RowanSOM enter into a contract with janitorial services, waste disposal of sealed materials, or equipment repair because the performance of such services does not involve the use and disclosure of PHI. In this case, any incidental contacts or disclosures are permitted under the federal privacy laws as an incidental disclosure, provided that reasonable safeguards are in place to prevent such disclosures.
    4. No contract is needed with another healthcare provider when the use or disclosure of the PHI is for treatment purposes.
      1. If the relationship between the healthcare providers also includes involvement of PHI for operational or payment purposes, then a contract is necessary.

        Examples: A hospital enlists the services of another healthcare provider to assist in the hospital's training of medical students. A physician, outside the workforce, serves as a medical director, or provides quality assurance or utilization management services through participation in hospital committees.
      2. For the definition and examples of the term treatment, payment, operations see EXHIBIT C.
    5. If it is unclear as to whether the business associate definition has been met or if it is met, whether a contract is necessary, contact Legal Management for assistance. Generally, if it continues to be unclear as to whether there is a business associate relationship, no information should be shared with the person or entity without the patient's authorization.

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  1. Documentation of Business Associate Agreement
    1. RowanSOM and its units will document the satisfactory assurances of protecting health information through a written contract with the business associate that meets the applicable requirements of the Health Insurance and Portability Act (HIPAA), 45 CFR 164.504(e) and 164.308(b).
    2. All RowanSOM units must assure that the individuals and entities identified above agree in writing to the provisions in the attached business associate contract prior to engaging their services or allowing them to encounter any PHI. See EXHIBIT D.
  2. Disclosure of Protected Health Information

    RowanSOM and its units may disclose protected health information (PHI) to a business associate and may allow a business associate to create or receive PHI on its behalf, if satisfactory assurances are obtained that the business associate will appropriately safeguard the information. The CE and BA must maintain an accurate disclosure log, including who, what, when, where and why PHI was disclosed. The sale of PHI occurs when the CE or BA receive renumeration; directly or indirectly, from or on behalf of the recipient of PHI. The sale of PHI generally means disclosure of PHI. Additional individual authorization is required for disclosure of psychotherapy notes and marketing purposes.
  3. Responsibility of Individuals Authorized to Contract for Rowan University

    Any individual authorized to contract for RowanSOM, or who enters into any form of relationship on behalf of RowanSOM; in which PHI is exchanged or in which another entity has access to PHI other than a relationship with another treating provider relating to the treatment of patients, is responsible to obtain satisfactory assurances of protecting health information through the approved business associate contracting process and with the approved business associate contract. Failure to meet this responsibility is subject to disciplinary action up to and including termination and/or dismissal.
  4. RowanSOM and its units must require business associates to return or destroy all PHI in its possession at the termination of the contract when feasible and permitted by law.
  5. For purposes of internal monitoring of compliance with this policy and procedure, all RowanSOM units must maintain a log of all arrangements with parties outside of the workforce accessing business associate arrangements including:
    1. The name of the business associate.
    2. The type of services provided to RowanSOM, or the function or activity performed on behalf of RowanSOM.
    3. The date the business associate provisions were entered into.
    4. The date the performance or services begin.
    5. The type of protected health information that will be shared with the business associate.
    6. Whether any of the protected health information will be shared through electronic means.
  6. The above log must be made available to RowanSOM and the unit's privacy officers upon request.
  7. Business associates may only use and disclose PHI to the extent that RowanSOM would be allowed to use and disclose the information. See RowanSOM policy, Uses and Disclosures of Health Information With and Without an Authorization. Only the information minimally necessary to complete the purpose of the service or function may be shared.

VII.   ATTACHMENTS

A. Is a Person or Entity a "Business Associate" and Required to Enter Into a Written Business Associate Contract?

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Rowan Security Officer

 




ATTACHMENT 1
Is a Person or Entity a "Business Associate" and 
Required to Enter Into a Written Business Associate Contract?


 



ATTACHMENT 2 
Examples of Potential Business Associates 
(This is not an all-inclusive list, nor is every arrangement listed necessarily a business associate. Use the attached flowchart and policy and procedure to analyze whether the relationship is a business associate relationship under HIPPA. Contact Legal Management at 2-4705 for assistance in the analysis.)

 

Accountants

Accounting services and firms

Accreditation services

Actuarial services

Actuarial specialists

Adjudication services

Administrative services

Advertisers

Architects, builders, and contractors

Asset-based lenders to healthcare facilities

Attorneys

Auditors

Billing service companies

Bulk mailing services

Care management programs

Civic groups and other local groups help out on ad hoc basis with patients who are hospitalized for a traumatic event or complicated illness (e.g., Shrine Temples, Ronald McDonald House)

Coding providers and experts

Community health management information systems

Computer maintenance services and companies

Consulting services

Contract Research Organization – An entity used by pharmaceutical and device manufactures to monitor clinical research trials

Copy services

Data aggregation services

Device manufactures

Document storage and destruction vendors

Financial service companies

Government health data systems

Hardware vendors

Healthcare consultants (e.g., risk management, information technology, billing, coding and management)

Hospital associations (National and State)

HVAC vendors

Independent contractors

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ATTACHMENT 2 (continued) 
Examples of Potential Business Associates


 

Independent service organizations (ISO) offering clinical/biomedical engineering services

Insurance brokers

Interpreter services (both deaf and foreign language)

Janitorial services; waste disposal and recycling services and companies

Law firms, its staff and employees

Lobbyists

Mailing houses

Maintenance contractors

Management services

Marketing services or firms

Medical equipment testing/ repair services

Medical or Physician associations (National and State)

Medical record moving companies

Medical record storage companies

Medical record transcription services

Medical software vendors

Microfilm conversion providers

Organ and Tissue Banks

Organ procurement organization

Outsourced document shredders

Patient advocates

Pharmaceutical companies

Pharmaceutical manufacturers

Pharmaceutical representatives

Plasma Donor Centers

Printing companies (ID cards and other member materials)

Private health data systems

Professional liability insurance carriers

Recycling services and companies

Software vendors

Sperm Banks

Temporary Staffing Companies

Third-party administrators

Trade associations

Utilization management vendors

Value added networks

Vendors to business associates if involving the disclosure of independently identifiable health information

Waste disposal services and companies

 

 

ATTACHMENT 3

Treatment, Payment and Health Care Operations 

I. "Treatment" - the provision, coordination, or management of health care and related services by one or more health care providers, including:

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    1. Resolution of internal grievances;
    2. Due diligence in connection with the sale or transfer of assets to a potential successor in interest, if the potential successor in interest is a covered entity or, following completion of the sale or transfer, will become a covered entity.

 

ATTACHMENT 4

Business Associates Agreement Involving the Access to Protected Health Information 

This Business Associate Agreement

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