Who must comply with HIPAA privacy standards?
As required by Congress in HIPAA, the Privacy Rule covers:
Health care clearinghouses
Health care providers who conduct certain financial and administrative transactions electronically. These electronic transactions are those for which standards have been adopted by the Secretary under HIPAA, such as electronic billing and fund transfers.
These entities (collectively called “covered entities”) are bound by the privacy standards even if they contract with others (called “business associates”) to perform some of their essential functions. The law does not give the Department of Health and Human Services (HHS) the authority to regulate other types of private businesses or public agencies through this regulation. For example, HHS does not have the authority to regulate employers, life insurance companies, or public agencies that deliver social security or welfare benefits. See our business associate section and the frequently asked questions about business associates for a more detailed discussion of the covered entities’ responsibilities when they engage others to perform essential functions or services for them.
When is an authorization required from the patient before a provider or health plan engages in marketing to that individual?
The HIPAA Privacy Rule expressly requires an authorization for uses or disclosures of protected health information for ALL marketing communications, except in two circumstances:
When the communication occurs in a face-to-face encounter between the covered entity and the individual; or
The communication involves a promotional gift of nominal value.
If the marketing communication involves direct or indirect remuneration to the covered entity from a third party, the authorization must state that such remuneration is involved.
How can I distinguish between activities for treatment or health care operations versus marketing activities?
The overlap among common usages of the terms “treatment,” “healthcare operations,” and “marketing” is unavoidable. For instance, in recommending treatments, providers and health plans sometimes advise patients to purchase goods and services. Similarly, when a health plan explains to its members the benefits it provides, it too is encouraging the use or purchase of goods and services.
The HIPAA Privacy Rule defines these terms specifically, so they can be distinguished. For example, the Privacy Rule excludes treatment communications and certain health care operations activities from the definition of “marketing.” If a communication falls under one of the definition’s exceptions, the marketing rules do not apply. In these cases, covered entities may engage in the activity without first obtaining an authorization. See the fact sheet on this web site about marketing, as well as the definition of “marketing” at 45 CFR 164.501,for more information.
However, if a health care operation communication does not fall within one of these specific exceptions to the marketing definition, and the communication falls under the definition of “marketing,” the Privacy Rule’s provisions restricting the use or disclosure of protected health information for marketing purposes will apply. For these marketing communications, the individual’s authorization is required before a covered entity may use or disclose protected health information.
Do disease management, health promotion, preventive care, and wellness programs fall under the HIPAA Privacy Rule's definition of "marketing"?
Generally, no. To the extent the disease management or wellness program is operated by the covered entity directly or by a business associate, communications about such programs are not marketing because they are about the covered entity’s own health-related services. So, for example, a hospital’s Wellness Department could start a weight-loss program and send a flyer to all patients seen in the hospital over the past year who meet the definition of obese, even if those individuals were not specifically seen for obesity when they were in the hospital.
Moreover, a communication that merely promotes health in a general manner and does not promote a specific product or service from a particular provider does not meet the definition of “marketing.” Such communications may include population-based activities in the areas of health education or disease prevention. Examples of general health promotional material include:
mailings reminding women to get an annual mammogram;
mailings providing information about how to lower cholesterol, new developments in health care (e.g., new diagnostic tools),
cancer prevention, and
Can health care providers invite or arrange for members of the media, including film crews, to enter treatment areas of their facilities without prior written authorization?
Health care providers cannot invite or allow media personnel, including film crews, into treatment or other areas of their facilities where patients’ PHI will be accessible in written, electronic, oral, or other visual or audio form, or otherwise make PHI accessible to the media, without prior written authorization from each individual who is or will be in the area or whose PHI otherwise will be accessible to the media. Only in very limited circumstances, as set forth below, does the HIPAA Privacy Rule permit health care providers to disclose protected health information to members of the media without a prior authorization signed by the individual.
A covered entity, including a health care provider, may not use or disclose protected health information (PHI), except either: (1) as the HIPAA Privacy Rule permits or requires; or (2) as the individual who is the subject of the information (or the individual’s personal representative) authorizes in writing. Generally, the HIPAA Privacy Rule does not permit health care providers to disclose PHI to media personnel, including film crews, without having previously obtained a HIPAA-compliant authorization signed by the patient or his or her personal representative. In other words, health care providers may not allow members of the media, including film crews, into treatment areas of their facilities or other areas where PHI will be accessible in written, electronic, oral or other visual or audio form, without prior authorization from the patients who are or will be in the area or whose PHI will be accessible to the media. It is not sufficient for a health care provider to request or require media personnel to mask the identities of patients (using techniques such as blurring, pixelation, or voice alteration software) for whom an authorization was not obtained, because the HIPAA Privacy Rule does not allow media access to the patients’ PHI, absent an authorization, in the first place.
In addition, the health care provider must ensure that reasonable safeguards are in place to protect against impermissible disclosures or to limit incidental disclosures of other PHI that may be in the area but for which an authorization has not been obtained.
There are very limited situations in which the HIPAA Privacy Rule permits a covered entity to disclose limited PHI to the media without obtaining a HIPAA authorization. For example, a covered entity may seek to have the media help identify or locate the family of an unidentified and incapacitated patient in its care. In that case, the covered entity may disclose limited PHI about the incapacitated patient to the media if, in the hospital’s professional judgment, doing so is in the patient’s best interest. See 45 C.F.R. 164.510(b)(1)(ii). In addition, a covered entity may disclose a patient’s location in the facility and condition in general terms that do not communicate specific medical information about the individual to any person, including the media, without obtaining a HIPAA authorization where the individual has not objected to his information being included in the facility directory, and the media representative or other person asks for the individual by name. See 45 C.F.R. 164.510(a).
The HIPAA Privacy Rule does not require health care providers to prevent members of the media from entering areas of their facilities that are otherwise generally accessible to the public, which may include public waiting areas or areas where the public enters or exits the facility.
A health care provider may utilize the services of a contract film crew to produce training videos or public relations materials on the provider’s behalf if certain protections are in place. If patients are to be identified by the provider and interviewed by a film crew, or if PHI might be accessible during filming or otherwise disclosed, the provider must enter into a HIPAA business associate agreement with the film crew acting as a business associate. Among other requirements, the business associate agreement must ensure that the film crew will safeguard the PHI it obtains, only use or disclose the PHI for the purposes provided in the agreement, and return or destroy any PHI after the work for the health care provider has been completed. See 45 C.F.R. 164.504(e)(2). As a business associate, the film crew must comply with the HIPAA Security Rule and a number of provisions in the Privacy Rule, including the Rule’s restrictions on the use and disclosure of PHI. In addition, authorizations from patients whose PHI is included in any materials would be required before such materials are posted online, printed in brochures for the public, or otherwise publicly disseminated.
Finally, covered entities can continue to inform the media of their treatment services and programs so that the media can better inform the public, provided that, in doing so, the covered entity does not share PHI with the media without the prior authorization of the individuals who are the subject of the PHI.
BE ADVISED: This page is provided as information only. It should not be confused or considered legal advice. You should always consult an attorney or your legal counsel for legal advice!