Page History

...

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)].

1. Except as provided in paragraph two (2) of this definition that is: a) transmitted by electronic media; b) maintained in electronic media; or c) transmitted or maintained in any other form or medium.
2. Protected health information excludes individually identifiable health information in: a) Education records covered by the Family Educational Rights and Privacy Act, as amended, 20 U.S.C. 1232g; b) Records described at 20 U.S.C. 1232g(a)(4)(B)(iv); and c) Employment records held by a covered entity in its role as employer.

B. "Business Associates (BA)" – Entity that "creates, receives, maintains, or transmits" PHI on behalf of the CE [Patient Safety and Quality Improvement Act (PSQIA) of 2005, 42 U.S.C. 299b-22, et seq.]. The BA now has direct liability for compliance with this rule (164.500), including implementing and operating Minimum Necessary [164.502(b)]. A Subcontractor is a person, who the BA has delegated a function, activity or services that the BA has agreed to perform on behalf of the CE (160.103). Subcontractors must also comply with the privacy and security rules under the BA Agreement [164.504(e)(4)(ii)(B)]. The CE and BA are obligated to assess, administer and monitor of the organizations "downstream" from the CE that manage PHI. The BA is required to enter into a BA Agreement (BAA) with the subcontractor, not the CE and subcontractor. person other than in the capacity of a member of the workforce that on behalf of RowanSOM, its units, or any organized health care arrangement in which it participates, performs or assists in the performance of:

1. a function or activity involving the use or disclosure of individually identifiable health information, including claims processing or administration, data analysis, processing or administration, utilization review, quality assurance, billing, benefit management, practice management and re-pricing; or
2. any other function or activity regulated by HIPAA regulations; or
3. provides legal, actuarial, accounting, auditing, consulting, data aggregation (as defined in CFR § 164.501), management, administrative, accreditation, or financial services to or for RowanSOM University and/or its units, or to or for an organized health care arrangement in which RowanSOM and or its units participate, where the provision of the service involves the disclosure of individually identifiable health information from such entities or arrangement, or from another business associate of such entities or arrangement, to the person.

• • • Includes; Patient Safety Organizations (PSO) which receives patient safety from providers and analyses for purposes of compliance with PSQIA and the Patient Safety Rule, 42 CFR 3.10, et seq. Section 13408 includes Health Information Organization (HIO), E-prescribing gateway or Regional Health Information Organization which on a "routine basis", maintains, oversees and governs the exchange of health related information between organizations, as BA.

C. "Workforce" – Faculty, employees, students, volunteers, trainees, and other persons whose conduct, in the performance of work for RowanSOM and/or its units, is under the direct control of such entity(ies), whether or not they are paid by Rowan University SOM.

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

B. 45 CFR 164.501(e), Code of Federal Regulations, Title 45, Part 164, Section 501, Subpart E, Security and Privacy, Definitions, Privacy of Individually Identifiable Health Information

C. 45 CFR 164.502(e), Code of Federal Regulations, Title 45, Part 164, Section 502, Subpart E, Security and Privacy, Uses and Disclosures of Protected Health Information: General Rules, Privacy of Individually Identifiable Health Information

D. 45 CFR 164.504(e), Code of Federal Regulations, Title 45, Part 164, Section 504, Subpart E, Security and Privacy, Uses and Disclosures: Organizational Requirements, Privacy of Individually Identifiable Health Information

E. 45 CFR 164.532 (d) and (e), Code of Federal Regulations, Title 45, Part 164, Section 532, Subpart E, Security and Privacy, Uses and disclosures: Organizational requirements, Privacy of Individually Identifiable Health Information and (d) Standard: Effect of Prior Contracts or Other Arrangements with Business Associates

F. Section 13404 and 13410(d) of the HITECH Act - Breach Notification Interim Final Regulation (74 FR 42740) - August 2009.

G. Uses and Disclosures of Health Information With and Without an Authorization

H. Omnibus Privacy Final Rule 2013

 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).
    
   3. 1. 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.
      2. 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.
      3. 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.
      4. 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.

   B. Responsibilities:

   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?

   B. Examples of Potential Business Associates

    C. Treatment, Payment and Health Care Operations

    D. Business Associates Agreement Involving the Access to Protected Health Information

   E. Hyperlink

    

   By Direction of the President:

   ...

   Rowan Security Officer

    

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

   
   

    

   
   
   ATTACHMENT 2B 
   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

    

    

   
   ATTACHMENT 2 B (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

   ...

    C

   Treatment, Payment and Health Care Operations 

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

   1. the coordination or management of health care by a health care provider with a third party;
   2. consultation between health care providers relating to a patient; or
   3. the referral of a patient for health care from one health care provider to another. 

   BII. "Payment" - the activities undertaken to obtain payment for the provision of healthcare; and relates to the individual to whom health care is provided and includes, but is not limited to:

   ...

   1. 1. Name and address;
      2. Date of Birth;
      3. Social Security Number;
      4. Payment history;
      5. Account number; and
      6. Name and address of the health care provider and/or health plan.

   CIII. "Health Care Operations" - any of the following activities:

   ...

   1. 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

   ...

   D

   Business Associates Agreement Involving the Access to Protected Health Information 

   ...

                                               

   ATTACHMENT E

   HYPERLINK

    

   Anchor
   1 1

   [1]   An expanded definition of the following terms, as well as the definition of other relevant terms are availableon RowanSOM website at https://www.rowan.edu/compliance. Terms used in this Business Associate Agreement but not otherwise defined shall have the meaning ascribed to those terms in HIPAA, the HITECH Act, and any current and future regulations promulgated under HIPAA and/or the HITECH Act.   See 45 C.F.R. 160.103, 164.402 and 164.501.