42 U.S.C. § 17932: Notification in the case of…

Summary

Covered entities that hold unsecured protected health information must tell people if their information was breached. If a business associate discovers a breach, it must tell the covered entity and identify the people affected. A breach is considered discovered on the first day the entity knows or should reasonably have known about it. Notices must be sent as soon as possible and no later than 60 calendar days after discovery. The entity must be able to prove it sent the notices and explain any delay. Notices to people are usually by first-class mail or by email if the person asked for that. If contact information is missing, the entity must use substitute notice; if 10 or more people lack contact info, the substitute can be a web posting or media notice and must include a toll-free phone number. If the breach affects more than 500 residents of a State, the entity must also notify prominent media in that State and notify the Secretary of Health and Human Services immediately. For breaches under 500 people, the entity can keep a log and send it to the Secretary once a year. The notice must say what happened (with dates if known), what kinds of information were involved, steps people can take, what the entity is doing, and how to get more information (including a toll-free number). Law enforcement can require a delay if notice would harm an investigation or national security. The Secretary must issue guidance on what counts as “secured” information within 60 days after February 17, 2009, issue rules within 180 days after that date, and report yearly to Congress on breaches reported to the Secretary.

Title 42, §17932

The Public Health and Welfare, Source: USLM XML via OLRC

(a)In general

A covered entity that accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured protected health information (as defined in subsection (h)(1)) shall, in the case of a breach of such information that is discovered by the covered entity, notify each individual whose unsecured protected health information has been, or is reasonably believed by the covered entity to have been, accessed, acquired, or disclosed as a result of such breach.

(b)Notification of covered entity by business associate

A business associate of a covered entity that accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured protected health information shall, following the discovery of a breach of such information, notify the covered entity of such breach. Such notice shall include the identification of each individual whose unsecured protected health information has been, or is reasonably believed by the business associate to have been, accessed, acquired, or disclosed during such breach.

(c)Breaches treated as discovered

For purposes of this section, a breach shall be treated as discovered by a covered entity or by a business associate as of the first day on which such breach is known to such entity or associate, respectively, (including any person, other than the individual committing the breach, that is an employee, officer, or other agent of such entity or associate, respectively) or should reasonably have been known to such entity or associate (or person) to have occurred.

(d)Timeliness of notification

(1)In general

Subject to subsection (g), all notifications required under this section shall be made without unreasonable delay and in no case later than 60 calendar days after the discovery of a breach by the covered entity involved (or business associate involved in the case of a notification required under subsection (b)).

(2)Burden of proof

The covered entity involved (or business associate involved in the case of a notification required under subsection (b)), shall have the burden of demonstrating that all notifications were made as required under this part, including evidence demonstrating the necessity of any delay.

(e)Methods of notice

(1)Individual notice

Notice required under this section to be provided to an individual, with respect to a breach, shall be provided promptly and in the following form:

(A)Written notification by first-class mail to the individual (or the next of kin of the individual if the individual is deceased) at the last known address of the individual or the next of kin, respectively, or, if specified as a preference by the individual, by electronic mail. The notification may be provided in one or more mailings as information is available.

(B)In the case in which there is insufficient, or out-of-date contact information (including a phone number, email address, or any other form of appropriate communication) that precludes direct written (or, if specified by the individual under subparagraph (A), electronic) notification to the individual, a substitute form of notice shall be provided, including, in the case that there are 10 or more individuals for which there is insufficient or out-of-date contact information, a conspicuous posting for a period determined by the Secretary on the home page of the Web site of the covered entity involved or notice in major print or broadcast media, including major media in geographic areas where the individuals affected by the breach likely reside. Such a notice in media or web posting will include a toll-free phone number where an individual can learn whether or not the individual’s unsecured protected health information is possibly included in the breach.

(C)In any case deemed by the covered entity involved to require urgency because of possible imminent misuse of unsecured protected health information, the covered entity, in addition to notice provided under subparagraph (A), may provide information to individuals by telephone or other means, as appropriate.

(2)Media notice

Notice shall be provided to prominent media outlets serving a State or jurisdiction, following the discovery of a breach described in subsection (a), if the unsecured protected health information of more than 500 residents of such State or jurisdiction is, or is reasonably believed to have been, accessed, acquired, or disclosed during such breach.

(3)Notice to Secretary

Notice shall be provided to the Secretary by covered entities of unsecured protected health information that has been acquired or disclosed in a breach. If the breach was with respect to 500 or more individuals than such notice must be provided immediately. If the breach was with respect to less than 500 individuals, the covered entity may maintain a log of any such breach occurring and annually submit such a log to the Secretary documenting such breaches occurring during the year involved.

(4)Posting on HHS public website

The Secretary shall make available to the public on the Internet website of the Department of Health and Human Services a list that identifies each covered entity involved in a breach described in subsection (a) in which the unsecured protected health information of more than 500 individuals is acquired or disclosed.

(f)Content of notification

Regardless of the method by which notice is provided to individuals under this section, notice of a breach shall include, to the extent possible, the following:

(1)A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known.

(2)A description of the types of unsecured protected health information that were involved in the breach (such as full name, Social Security number, date of birth, home address, account number, or disability code).

(3)The steps individuals should take to protect themselves from potential harm resulting from the breach.

(4)A brief description of what the covered entity involved is doing to investigate the breach, to mitigate losses, and to protect against any further breaches.

(5)Contact procedures for individuals to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, Web site, or postal address.

(g)Delay of notification authorized for law enforcement purposes

If a law enforcement official determines that a notification, notice, or posting required under this section would impede a criminal investigation or cause damage to national security, such notification, notice, or posting shall be delayed in the same manner as provided under section 164.528(a)(2) of title 45, Code of Federal Regulations, in the case of a disclosure covered under such section.

(h)Unsecured protected health information

(1)Definition

(A)In general

Subject to subparagraph (B), for purposes of this section, the term “unsecured protected health information” means protected health information that is not secured through the use of a technology or methodology specified by the Secretary in the guidance issued under paragraph (2).

(B)Exception in case timely guidance not issued

In the case that the Secretary does not issue guidance under paragraph (2) by the date specified in such paragraph, for purposes of this section, the term “unsecured protected health information” shall mean protected health information that is not secured by a technology standard that renders protected health information unusable, unreadable, or indecipherable to unauthorized individuals and is developed or endorsed by a standards developing organization that is accredited by the American National Standards Institute.

(2)Guidance

For purposes of paragraph (1) and section 17937(f)(3) of this title, not later than the date that is 60 days after February 17, 2009, the Secretary shall, after consultation with stakeholders, issue (and annually update) guidance specifying the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals, including the use of standards developed under section 300jj–12(b)(2)(B)(vi) of this title, as added by section 13101 of this Act.

(i)Report to Congress on breaches

(1)In general

Not later than 12 months after February 17, 2009, and annually thereafter, the Secretary shall prepare and submit to the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives a report containing the information described in paragraph (2) regarding breaches for which notice was provided to the Secretary under subsection (e)(3).

(2)Information

The information described in this paragraph regarding breaches specified in paragraph (1) shall include—

(A)the number and nature of such breaches; and

(B)actions taken in response to such breaches.

(j)Regulations; effective date

To carry out this section, the Secretary of Health and Human Services shall promulgate interim final regulations by not later than the date that is 180 days after February 17, 2009. The provisions of this section shall apply to breaches that are discovered on or after the date that is 30 days after the date of publication of such interim final regulations.

Notes & Related Subsidiaries

Editorial Notes

References in Text

section 300jj–12(b)(2)(B)(vi) of this title, referred to in subsec. (h)(2), was repealed by Pub. L. 114–255, div. A, title IV, § 4003(e)(1), Dec. 13, 2016, 130 Stat. 1168. Similar provisions as pertaining to the HIT Advisory Committee are contained in section 300jj–12(b)(2)(C)(vii) of this title as enacted by Pub. L. 114–255. section 13101 of this Act, referred to in subsec. (h)(2), means section 13101 of div. A of Pub. L. 111–5.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 12 months after Feb. 17, 2009, except as otherwise specifically provided, see section 13423 of Pub. L. 111–5, set out as a note under section 17931 of this title.

§17932 Notification in the Case of Breach