As health care providers, patients, family members, friends, and disaster relief agencies such as the American Red Cross continue to grapple with the aftermath of Hurricane Sandy it is important to be mindful of privacy regulations and to prepare in advance for the next emergency. The Health Insurance Portability and Accountability Act  of 1996 (“HIPAA” or “Privacy Rule”) protects individually identifiable health information held by “covered entities.” The information protected is referred to as protected health information or PHI. The Privacy Rule permits covered entities to disclose PHI for a variety of purposes including to (a) treat patients; (b) identify, locate and notify family members, guardians, or anyone else responsible for an individual’s care; (c) obtain the services of disaster relief agencies; (d) conduct public health activities; and (e) prevent or lessen serious and imminent threats to health or safety.

The U.S. Department of Health and Human Services (“HHS”) provides guidelines for disclosures before and during emergencies.  HHS developed a flowchart decision tool to assist health care providers during a public health emergency.  Here is a link to HHS’s Flowchart Decision Tool.  The Flowchart Decision Tool asks three essential questions.  First, who is the source of the information to be disclosed?  If the source of the information is a covered entity (i.e., a health plan, health care provider, or a health care clearinghouse) then the decision maker needs to answer the next question.  Second, to whom is the information being disclosed?  Is the recipient of the information a Public Health Authority (“PHA”)?  A PHA is defined as an agency or authority of the United States Government, a State, a territory, a political subdivision of a State or territory, or an Indian tribe, that is responsible for public health matters as a part of its official mandate, or a person or entity acting under a grant of authority from a contract with such agency.  Third, does the covered entity have a signed authorization permitting the disclosure?  The covered entity must obtain individual authorization, unless the disclosure is permitted by another provision of the Privacy Rule (i.e., obtain the services of disaster relief agencies or prevent or lessen serious and imminent threats to health and safety).  A valid authorization includes (a) a meaningful description of the information to be disclosed; (b) the name of the individual or the name of the person authorized to make the requested disclosure; (c) the name or other identification of the recipient of the information; (d) a description of each purpose of the disclosure; (e) an expiration date or an expiration event that relates to the individual; and (e) a signature of the individual or their personal representative and the date.

Health care providers are allowed to share PHI as necessary to carry out treatment.  See 45 CFR 164.502(a)(1)(ii) and 164.506(c).  After Hurricane Katrina, HHS Office for Civil Rights issued a Hurricane Katrina Bulletin: HIPAA Privacy and Disclosures in Emergency Situations on September 2, 2005 (“Bulletin #1”).   Treatment was broadly defined to include (a) sharing information with other providers (including hospitals and clinics); (b) referring patients for treatment (including linking patients with available providers in areas where the patients have relocated), and (c) coordinating patient care with others (such as emergency relief workers or others that can help in finding patients appropriate health services).  Bulletin #1 also clarified that when a health care provider is sharing information with a disaster relief organization authorized by law or by their charters, like the American Red Cross, it is unnecessary to obtain a patient’s permission to share PHI if so doing so would interfere with the organization’s ability to respond to the emergency.

The President and the HHS Secretary also have the authority to temporarily waive additional HIPAA requirements in an emergency.  This is exactly what happen with Hurricane Sandy.  October 30, 2012, President Obama declared under the Robert T. Stafford Disaster Relief and Emergency Assistance Act that a major disaster exists in New York and New Jersey as a result of Hurricane Sandy.  The President’s declaration was retroactive to October 27, 2012.  On October 31, 2012, HHS Secretary Sebelius declared a public health emergency and authorized waivers and modifications under Section 1135 of the Social Security Act for New York and New Jersey.  These waivers were retroactive to October 27, 2012.

Section 1135 waives sanctions and penalties arising from noncompliance with the following provisions of the HIPAA privacy regulations:  (a) the requirements to obtain a patient’s agreement to speak with family members or friends or to honor a patient’s request to opt out of the facility directory; (b) the requirement to distribute a notice of privacy practices; and (c) the patient’s right to request privacy restrictions or confidential communications.  However Section 1135 waivers are limited to the designated geographic area and only during the emergency period.  Waivers of these HIPAA requirements are limited to a 72 hour period. Here are copies of HHS Secretary Sebelius’s Section 1135 waivers for New York and New Jersey.


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Photo of Ryan P. Blaney Ryan P. Blaney

Ryan Blaney represents health care, life science, and technology clients in a range of regulatory, enforcement, internal investigative and transactional matters, with particular expertise in privacy law, life sciences and digital health. He also has expertise in regulatory compliance, counseling clients on a…

Ryan Blaney represents health care, life science, and technology clients in a range of regulatory, enforcement, internal investigative and transactional matters, with particular expertise in privacy law, life sciences and digital health. He also has expertise in regulatory compliance, counseling clients on a range of matters, including health care fraud and abuse, third party reimbursement, data breach issues, data privacy and security, and FDA regulatory matters. He has substantial experience in pharmaceutical lifecycle management and competition issues, including the Hatch- Waxman Act and Biosimilars Price Competition and Innovations Act.

Ryan serves information technology companies, public and private health care companies, hospitals and physician organizations, manufacturers, medical device companies, and health plans. He guides venture capital groups, private equity funds, investment banks, and other investors on health care regulatory issues in connection with financing, mergers and acquisitions, and restructuring.

Ryan’s work is greatly informed by his experience as a teacher. Prior to attending law school, Ryan earned a master’s degree in education and taught at an under-resourced Catholic middle school. He is known for his ability to communicate clearly and to coordinate large teams working on complex matters. Outside of his health law practice, Ryan has been repeatedly recognized for his public service and pro bono work. He has successfully handled numerous education-related cases, helped establish three nonprofit organizations and defended qualified recipients of disability benefits.