164.512(j)		    
9.7.
Uses and Disclosures to Avert a Serious Threat to Health or Safety:
   
 
9.7.1.
CE may, consistent with applicable law and standards of ethical conduct, use or disclose PHI if the CE in good faith believes the use or disclosure is:
9.7.1.1.
Necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public and is to a person or persons reasonably able to prevent or lessen the threat, including the target of the threat; or
9.7.1.2.
Necessary for law enforcement authorities to identify or apprehend an individual:
9.7.1.2.1.
Because of a statement by an individual admitting participation in a violent crime that the CE reasonably believes may have caused serious physical harm to the victim, or
9.7.1.2.2.
Where it appears from all circumstances that the individual has escaped from a correctional institution or from lawful custody.
 
9.7.2.
Use/disclosure not permitted: A use or disclosure pursuant to ¶ 9.7.1.2.1. may not be made if the information described therein is learned by the CE in the course of treatment to affect the propensity to commit the criminal conduct that is the basis for the disclosure, or counseling or therapy; or through a request by the individual to initiate or to be referred for the treatment, counseling, or therapy.
 
9.7.3.
Limit on information to be disclosed: A disclosure made pursuant to ¶ 9.7.1.2.1. shall contain only the statement described therein and the PHI described under ¶ 9.6.2.1. (disclosures for law enforcement for identification and location purposes).
 
9.7.4.
A CE is presumed to have acted in good faith if its belief is based upon the CE's actual knowledge or reliance on a credible representation by a person with apparent knowledge or authority.
164.512(i)    
9.8.
Uses and Disclosures for Research Purposes:
164.512(i)(1)    
 
9.8.1.
CE may use/disclose PHI for research, regardless of source of funding, provided that:
9.8.1.1.
CE obtains documentation that an alteration or waiver of the authorization required under 164.508 [¶ 7.] has been approved by either:
9.8.1.1.1.
An Institutional Review Board (IRB) established under cited sections of the CFR, or
9.8.1.1.2.
A Privacy Board that: (i) has members with varying backgrounds and appropriate professional competency to review the effect of the research protocol on privacy rights and related interests; (ii) includes at least one member who is not affiliated with the CE or the entity conducting or sponsoring the research, and is not related to anyone affiliated with these entities, and; (iii) does not have any member participating in a review of a project in which s/he has a conflicting interest.
9.8.1.2.
CE obtains from researcher representations that:
9.8.1.2.1.
Use/disclosure is sought solely to review PHI to prepare a research protocol, or for a similar preparatory purpose;
9.8.1.2.2.
No PHI will be removed from the CE, and;
9.8.1.2.3.
PHI sought is necessary for research purposes.
9.8.1.3.
For research on decedents' information, CE obtains from the researcher:
9.8.1.3.1.
Representation that use/disclosure is sought solely for research on PHI of decedents;
9.8.1.3.2.
Documentation of the death of individuals whose PHI is sought, upon request by the CE;
9.8.1.3.3.
Representation that the PHI is necessary for research purposes.
164.512(i)(2)    
 
9.8.2.
Documentation supporting approval of alteration/waiver per 164.512(i)(1)(i) [¶ 9.8.1.1.] must include:
9.8.2.1.
Identification of approving board and date of approval;
9.8.2.2.
Statement that board determined that alteration/waiver satisfies the following criteria;
9.8.2.2.1.
Use/disclosure of PHI involves no more than a minimal risk to the privacy of the individuals, based on, at least, the presence of the following elements;
9.8.2.2.1.1.
Adequate plan exists to protect identifiers from improper use/disclosure;
9.8.2.2.1.2.
Adequate plan exists to destroy identifiers unless there is justification for retention; and
9.8.2.2.1.3.
Adequate written assurances given that PHI will not be used or disclosed other than as authorized for research study or otherwise under law.
9.8.2.2.2.
The research could not practicably be conducted without the waiver or alteration; and
9.8.2.2.3.
The research could not practicably by conducted without access to and use of the PHI.
9.8.2.3.
A brief description of the PHI for which use or disclosure has been determined to be necessary by the IRB or privacy board has determined pursuant to ¶ 9.8.2.2.3;
9.8.2.4.
Statement that the alteration/waiver was reviewed and approved as follows:
9.8.2.4.1.
IRB must follow requirements of the Common Rule, including normal and expedited procedures (164.512(i)(2)(iv)(A));
9.8.2.4.2.
Privacy Board: normal review - must review at convened meetings where majority of members are present, including at least one member satisfying criteria of 164.512(i)(1)(i)(B)(2) [¶ 9.8.1.1.2.(ii)] (at least one member not affiliated with CE or conduct/sponsorship of project}; alteration/waiver must be approved by majority of members present; or
9.8.2.4.3.
Privacy Board: expedited review - may be used only if research involves no more than minimal risk to privacy; review and approval may be carried out by Chair, or one or more members as designated by Chair.
9.8.2.5.
Documentation must be signed by Chair of approving IRB or Privacy Board, or by member designated by Chair.
164.512(g)    
9.9.
Uses and Disclosures about Decedents:
9.9.1.
Coroners and Medical Examiners: CE may disclose PHI to a coroner or medical examiner to identify a deceased person, determine the cause of death, or perform other functions authorized by law. A CE may use PHI for these purposes if it functions as a coroner or medical examiner.
9.9.2.
Funeral Directors: CE may disclose PHI to funeral directors, consistent with applicable law, as necessary to carry their duties. If necessary, PHI may be disclosed prior to, and in reasonable anticipation of, the individual's death.
164.512(h)    
9.10.
Uses and Disclosures for Cadaveric Organ, Eye or Tissue Donation Purposes: CE may use or disclose PHI to organ procurement organizations or other entities engaged in procurement, banking, or transplantation of cadaveric organs, eyes or tissue for the purpose of facilitating organ, eye or tissue donation or transplantation.
     
     

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