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ROWAN UNIVERSITY POLICY

Title: Uses and Disclosures of Protected Health Information: With and Without Authorization
Subject: Office of Compliance & Corporate Integrity (OCCI)
Policy No: OCCI: 2013: P03
Applies: RowanSOM
Issuing Authority: Rowan President & RowanSOM Dean
Responsible Authority: RowanSOM Chief Compliance and Privacy Officer & Rowan Security Officer
Adopted:

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 01/31

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/2003
Amended:

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 07/01/2013
Reviewed:

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 01/12

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/2015

I.

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PURPOSE

To establish the requirement for Rowan School of Osteopathic Medicine (RowanSOM) uses and disclosures of individually identifiable protected health information (PHI) to be in conformance with state and federal regulations. This policy clarifies when an authorization is or is not required and/or clarifies when an opportunity to agree or disagree must be provided regarding the use and disclosure of protected health information. It establishes the necessary elements that must be included in these authorizations, and the extent of the information that may be used or disclosed.

II.

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ACCOUNTABILITY

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

III.

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APPLICABILITY

A. This policy applies to health information, including demographic information collected from an individual, whether oral or recorded in any form or medium, only when it meets the following conditions:

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B. This policy does not apply to health information in education records covered under the Federal Education Right and Privacy Act (FERPA), 20 USC 1232g; and records under FERPA at 20 USC 1232g(a)(4)(B)(iv). See University policy, Family Educational Rights and Privacy Act, 00-01-25-05:00.

IV.

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REFERENCES

A. 45 CFR 164.508 Code of Federal Regulations, Title 45, Part 164, Section 508, Security and Privacy, Uses and disclosures for which an authorization is required.

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F. Common Rule and FDA's Human Subject Protection Regulations

V.

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POLICY

A. RowanSOM and all its units shall appropriately protect the privacy of PHI that can identify an individual in compliance with federal and state law.

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  1. Each unit will verify the identity and authority of persons requesting PHI. Verification procedures should be reflected in policies and procedures accordingly.
  2. If the requesting person is a public official or someone acting on his or her behalf, units may rely upon the following:
    1. Agency identification badge, credentials or other proof of status;
    2. Government letterhead, if request is by letter;
    3. A written statement of the legal authority (or, if impracticable, an oral statement) under which the information is requested.
    4. If a request is made pursuant to a legal process, warrant, subpoena, order, or other legal process, it is presumed to constitute legal authority.
    5. For persons acting on behalf of the official, a written statement on government letterhead or other evidence or documentation that establishes that the person is acting under the public official's authority (such as contract for services, memo of understanding). In this event, units must contact the Office of Legal Management to inform of such request by Public Officials.
  3. A unit may rely on the exercise of professional judgment as to disclosures pursuant to facility directories, to persons involved in a patient's care or payment and notification, and in relation to disaster relief as discussed in section V.F.3 and as to disclosures regarding serious threats to health and safety as discussed in attachment B.

VI.

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ATTACHMENTS

A. Attachment 1 - , List of Identifiers and De-Identification Process

B. Attachment 2 - , Disclosures of PHI No Authorization Required

C. Attachment 3 - , Treatment, Payment and Health Care Operations

D. Attachment 4 - HYPERLINK, Hyperlink




By Direction of the President:

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Signature on file
Rowan Security Officer

ATTACHMENT 1

LIST OF IDENTIFIERS AND DE-IDENTIFICATION PROCESS



A. RowanSOM may use protected health information (PHI) where information that can identify the individual not present and where RowanSOM has no reasonable basis to believe that information can be used to identify the individual. RowanSOM can create de-identified information by removing, coding, encrypting, or otherwise eliminating or concealing the following information regarding the individual, relatives, employers, or household members:

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C.A covered entity can re-identify any information that has been de-identified as long as two conditions are satisfied. If the conditions are satisfied, a covered entity may use a code or some other method of recordation. First, the code or method of recordation cannot be derived from or related to information about the individual that would enable identification of the individual. Second, the covered entity cannot use or disclose either the code or other method of recordation or the mechanism for any other purpose or disclosure of the method for re-identification.

ATTACHMENT 2
DISCLOSURE OF PROTECTED HEALTH INFORMATION (PHI)
NO AUTHORIZATION REQUIRED

1.Public Health Activities

RowanSOM may disclose Protected Health Information (PHI) for public health activities as follows:

  1. To public health authority that is authorized by law:
    1. To collect or receive such information for the purpose of preventing or controlling disease, injury or disability;
    2. To receive reports of child abuse or neglect;
  2. To persons subject to the jurisdiction of the Food and Drug Administration:
    1. To report adverse events, product defects or problems, or biological product deviations if the disclosure is made to the person required or directed to report such information to the FDA;
    2. To track products if the disclosure is made to a person required or directed by the FDA to track the product;
    3. To enable product recalls, repairs, or replacement; or
    4. To conduct post-marketing surveillance to comply with requirements or at the direction of the FDA.
  3. To a person who may have been exposed to a communicable disease or may otherwise be at risk of contracting or spreading a disease or condition where RowanSOM is authorized by law to notify the person as necessary in the conduct of public health intervention or investigation; or
  4. To a RowanSOM Unit about an individual who is a member of the Unit's work force if:
    1. RowanSOM provides health care to the individual at the request of the Unit to conduct medical surveillance of the workplace or to evaluate individuals for work-related illness or injury;
    2. The PHI consists of findings concerning work-related illness or injury or workplace related medical surveillance;
    3. The Unit needs the findings to comply with its obligations under 29 CFR Part 1904-1928 (Occupational Safety and Health Administration regulations) or 30 CFR Parts 50-90 (Mine Safety and Health Administration) or under similar state law, to record such illness or injury or to carry out responsibilities for workplace medical surveillance; or
    4. RowanSOM gives written notice to the individual that PHI relating to the medical surveillance of the workplace and workplace related illnesses and injuries is disclosed to the Unit by giving a copy of the notice to the individual when the health care is provided or if the healthcare is provided on the worksite of the employer, by posting the notice prominently where the health care is provided.

2.Victims of Abuse, Neglect, or Domestic Violence

In addition, RowanSOM may disclose PHI to a government authority about individuals reasonably believed to be victims of abuse, neglect, or domestic violence. Such disclosures involving adults are permitted if:

  1. The disclosure is required by law and the disclosure is limited to the requirements of such law.
  2. The individual agrees to the disclosure.
  3. The disclosure is expressly authorized by statute or regulation, and
    1. RowanSOM believes the disclosure is necessary to prevent serious harm to the individual or other potential victims; or
    2. If the individual cannot agree because of incapacity, a law enforcement or other public official authorized to receive the report represents that the PHI is not intended to be used against the individual and that an immediate enforcement activity that depends upon the disclosure would be materially and adversely affected by waiting until the individual is able to agree to the disclosure.

RowanSOM must promptly inform the individual of such report unless the provider believes informing the individual would place the individual at risk of serious harm or the provider would be informing a personal representative that the covered entity believes is responsible for the abuse, neglect, or other injury, and that informing such person would not be in the best interest of the individual.

3.Health oversight activities

RowanSOM may disclose PHI to a health oversight agency for oversight activities authorized by law, including audits; civil, administrative, or criminal investigations; inspections; licensure or disciplinary actions; civil, administrative, or criminal proceedings or actions; or other activities necessary for the appropriate oversight of

  1. the health care system, 
  2. government benefit programs for which health information is relevant to beneficiary eligibility, 
  3. entities subject to government regulatory programs that need health information to determine compliance with program standards, or entities subject to civil rights law that need health information to determine compliance.

RowanSOM may not disclose PHI under this section if an investigation or other activity relates to an individual but does not arise out of and is not directly related to:

  1. the receipt of health care; 
  2. a claim for public benefits related to health; or 
  3. qualifications for, or receipt of, public benefits or services when a patient's health is integral to the claim for public benefits or services.

4.Judicial and administrative proceedings

The RowanSOM Office of Legal Management will respond to all judicial and administrative proceedings. The Office of Legal Management will review the requests and either responds to the issuer of the request or advice about compliance with the request.

5.Law enforcement purposes

RowanSOM may disclose PHI to a law enforcement official if:

  1. The law enforcement official is conducting or supervising a law enforcement inquiry or proceeding authorized by law and the disclosure is:
    1. A warrant, subpoena, or order issued by a judicial officer (that documents a finding by the judicial officer);
    2. A grand jury subpoena; or
    3. An administrative request, including an administrative subpoena or summons, a civil investigative demand, or similar process authorized under law, provided that:
      1. The information sought is relevant and material to a legitimate law enforcement inquiry;
      2. The request is as specific and narrowly drawn as is reasonably practicable; and
      3. De-identified information could not reasonably be used.
  2. If the disclosure is for the purpose of identifying a suspect, fugitive, material witness, or missing person, RowanSOM may disclose only the following information: 
    1. Name
    2. Address
    3. Social security number
    4. Date of birth
    5. Place of birth
    6. Type of injury or other distinguishing characteristic
    7. Date and time of treatment. 
  3. If the disclosure is of the PHI of an individual who is suspected to be a victim of a crime, abuse, or other harm, if the law enforcement official states that:
    1. such information is needed to determine whether a violation of law by a person other than the victim has occurred; and
    2. immediate law enforcement activity that depends upon obtaining such information may be necessary. 
  4. For purposes of alerting law enforcement of the death of an individual if the covered entity has a suspicion that such death may have resulted from criminal conduct.
  5. To a law enforcement official if the covered entity believes in good faith that the PHI constitutes evidence that criminal conduct occurred on the premises of the covered entity.
  6. Disclosure of PHI to a law enforcement official where: 
    1. a provider is providing health care in response to a medical emergency (other than on the premises of the provider) and
    2. such disclosure is necessary to alert law enforcement to the commission and nature of a crime, the location of the crime or its victims, and the identity, description, and location of the perpetrator (provided that victims of abuse, neglect or domestic violence will be treated in accordance with the provisions in Section 2 above). 

All requests for disclosure of PHI by a law enforcement official must be referred to Legal Management for review prior to disclosure.

6. Deceased Individuals

The PHI of a deceased individual may be disclosed without the personal representative's permission for three specific reasons that would not apply to living persons:

  1. For information needed by coroners, medical examiners and funeral directors.
  2. For information needed to facilitate an organ donation.
  3. To alert a law enforcement agency of the death if the covered entity has a suspicion that such death may have resulted from criminal conduct. If the agency is already investigating the death, other law enforcement powers to obtain PHI may apply. 

Otherwise, health records of deceased persons are protected as that of a living person and for up to 50 years after the pronouncement date.

7.Organ DonationRowanSOM may disclose PHI to organ procurement organizations or other entities engaged in procurement, banking, or transplantation of cadaveric organs, eyes or tissues for the purpose of facilitating organ, eye, or tissue donation and transplantation.
8.Research Purposes
  1. RowanSOM may use or disclose PHI for research, regardless of the source of funding of the research, provided that RowanSOM has obtained a written waiver, in whole or in part, of authorization for use or disclosure of PHI that has been approved by the IRB, in whole or in part, and satisfying the following criteria:
    1. The use or disclosure of PHI involves no more than minimal risk to the privacy of individuals, based on, at least, the presence of the following elements: 
      1. an adequate plan to protect the identifiers from improper use and disclosure;
      2. an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
      3. adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use and disclosure of PHI would be permitted under federal and state law.
    2. The research could not practicably be conducted without the waiver;
    3. The research could not practicably be conducted without access to and use of the PHI. 
  2. RowanSOM must obtain from the researcher representations that: 
    1. Use and disclosure is sought solely to review PHI as necessary to prepare a research protocol or for similar purposes preparatory to research; 
    2. No PHI is to be removed from Rowan University SOM by the researcher in the course of the review; and 
    3. The PHI for which use or access is sought is necessary for research purposes. 
  3. As to research on decedent's information, RowanSOM must obtain from the researcher:
    1. Representation that the use and disclosure is sought solely for research on the PHI of decedents;
    2. Documentation, at the request of RowanSOM, of the death of such individuals; and representation that the PHI for which use and disclosure is sought is necessary for research purposes.
9.Emergency Circumstances to Avert Threats to SafetyRowanSOM may, consistent with applicable law and standards of ethical conduct and based on a reasonable belief that the use or disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of an individual, use or disclose PHI to a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.
  1. In making such a disclosure, RowanSOM is presumed to have acted under a reasonable belief, if the disclosure is made in good faith based upon a credible representation by a person with apparent knowledge or authority (such as a doctor or law enforcement or other government official) (NJSA 2A:62A-16).


ATTACHMENT 3

TREATMENT, PAYMENT AND HEALTH CARE OPERATIONS

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

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  1. Conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, population-based activities relating to improving health or reducing health care costs, protocol development, case management and care coordination, contracting of health care providers and patients with information about treatment alternatives; and related functions that do not include treatment;
  2. Reviewing the competence or qualifications of health care professionals, evaluating practitioner and provider performance, health plan performance, conducting training programs in which students, trainees, or practitioners in areas of health care learn under supervision to practice or improve their skills as health care providers, training of non-health care providers, accreditation, certification, licensing, or credentialing activities;
  3. Conducting or arranging for medical review, legal services and auditing functions, including fraud and abuse detection and compliance programs;
  4. Business planning and development, such as conducting cost-management and planning-related analyses related to managing and operating the entity, including formulary development and administration, development or improvement of methods of payment or coverage policies; and
  5. Business management and general administrative activities of Rowan University School of Medicine, including, but not limited to:
    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.
A. [i] Authorization for Release of Information Form:  http://www.rowan.edu/compliance/documents/ROWANAuthorizationforReleaseForm.pdf