Stimulus Bill Requires Data Breach Notification Under HIPAA and Signals Broader Enforcement
The American Recovery and Reinvestment Act that President Obama signed into law on February 17, 2009 includes wide reaching data breach notification provisions for entities covered by the Health Insurance Portability and Accountability Act and organizations servicing those entities. It also has privacy provisions related to sales of protected health information, marketing, fines, and enforcement. The Act is likely to increase joint enforcement activities by the Federal Trade Commission and the Department of Health and Human Services Office for Civil Rights. Such enforcement will likely result in settlements similar to the CVS settlement on February 18, 2009 that arose out of improper disposal of protected health information.
I. Data Breach Notification
The Act places notification obligations on covered entities, business associates, and vendors of personal health records for breaches of protected health information as well as required updates to contracts between covered entities and business associates.
A. Covered Entities
Generally speaking and without using the defined terms of the Act, an entity’s duty to notify arises when it has a breach involving unencrypted personal health information that it processes. The entity must then notify, the individual, the media, and the Secretary of the DHHS within 60 days of finding out about the breach, so long as the law enforcement exception does not apply. In creating these obligations, the Act defines the terms breach, electronic health record, personal health record, and vendors, but retains the earlier definitions of covered entities and business associates from HIPAA. The Act and the obligation to notify will likely become effective for breaches discovered 210 days from its enactment.
A breach is the unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of such information. The term has several narrow exceptions related to inadvertent disclosures to authorized users. Most importantly, a breach is deemed to have been discovered on the first date on which it is known or reasonably should have been known to have occurred.
Covered entities still refer to health plans, health care clearinghouses, or health care providers who transmit any health information in electronic form. Processing, while not a term used in the language of the Act, includes access, maintenance, retention, modification, storage, destruction, using, or disclosing.
Unencrypted personal health information refers to the defined term unsecured protected healthcare information. The portion of term referring to protected healthcare information retains its definition under HIPAA and means individually identifiable health information that is either transmitted by electronic media or maintained in electronic media, or both. Unsecured, on the other hand has two meanings. The Secretary should issue guidance specifying the technologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals within 60 days. If he does not, then that technology will be a technology developed or endorsed by the American National Standards Institute. Though the Act does not specify that technology, it will probably be the Advanced Encryption Standard used by the Federal government for sensitive documents.
Notification takes 3 forms: individual, media, and the DHHS. Notification must be made without unreasonable delay and within 60 days after its discovery. However, the law enforcement exception can delay such notification if the entity receives and documents a written or oral statement from the DHHS. The burden to prove that the notification was performed according to the Act lies with the covered entity.
Entities must notify each individual whose unsecured protected health information has been, or is reasonably believed by the entity to have been accessed, acquired, or disclosed during the breach. This individual notice may be by first class mail at the last known address of the individual or by email if that is the preference of the individual. If the entity has more than 10 individuals with insufficient or out of date contact information, then it is required to place a conspicuous post on its web page or notice in major print or broadcast media for a period of time that the Secretary specifies. The entity may also notify by phone due to possible imminent misuse of the information.
The entity must notify prominent media outlets serving a state or jurisdiction if the information of more than 500 residents are reasonably believed to have been subject to the breach. The entity must also notify the Secretary. If the breach involves more than 500 individuals, the entity must notify immediately, whereas breaches involving less than 500 individuals may be submitted in an annual log. The Secretary is then required to post breaches involving more than 500 individuals on its website.
The Act delineates the contents of the notifications. They must include a brief description of the events, the date of the events, a description of the types of information involved, the steps the individuals should take to protect themselves from any harm that may result, and procedures for contacting the entity through a toll-free phone number, email address, or website.
The Secretary must also pass interim final regulations on breach notification within 180 days. These regulations will apply to breaches discovered after 30 days after their enactment. These regulations will certainly require covered entities to craft breach response procedures and implement them promptly.
B. Business Associates
Business associates that service covered entities under HIPAA have an obligation to notify the covered entities in the event of a breach. Business associates are now also subject to the same security procedures that covered entities are under HIPAA and these requirements must also be incorporated in their agreements.
The definition of a business associate has not changed with the Act. Business associates still refer to persons that perform or assist any activity involving the use or disclosure of individually identifiable health information or persons performing legal, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation, or financial services to or for such covered entity. The Act states that the business associates need to notify the covered entities who must then notify the individuals. However, the requirements related to timeliness and the discovery of the breach are the same.
Covered entities will need to amend their contracts with business associates to reflect the provisions of the Act. These amendments must include administrative safeguards, physical safeguards, technical safeguards, and policies and procedures and documentation requirements promulgated by the DHHS. Business associates that receive protected health information may be subject to fines for wrongful disclosures of protected health information. Prior to the Act, HIPAA only made business associates liable to the covered entity for contract breaches.
The Act also contains a whistle blowing provision for business entities and the covered entities they serve. Prior HIPAA regulations stated that a covered entity was non-compliant if it knew of a business associate’s activity that constituted a material breach of the associate’s contractual obligations and did not take reasonable steps to cure them. If the business associate did not cure the problems, the covered entity was required to terminate the contract or, if that was not feasible, inform the secretary. Now, the Act requires that business entities have the same whistle blowing responsibility towards the covered entities they service. Failure to do so is a violation of the Act.
C. Vendors and Non-HIPAA Covered Entities
The breach notification standards also apply to a new kind of entity called vendors under the Act. These are entities other than covered entities that offer or maintain personal health records. A personal health record is an electronic record of identifiable health information on an individual that can be drawn from multiple sources and that is managed, shared, and controlled by or primarily for the individual. Google Health and Microsoft HealthVault are examples of such entities.
A vendor’s obligations under the Act are similar to the covered entities’ and business associates’ responsibilities. Vendors must notify individuals and the Federal Trade Commission, instead of the DHHS, of data breaches. The FTC then notifies the DHHS. The methods and timeliness of these disclosures and the definitions of breach and unsecured protected health information are almost identical to the methods and timeliness that covered entities. Violation of this duty to notify is considered an unfair and deceptive trade practice under the FTC Act. Third party services providers that service vendors have an obligation to notify their vendors of any breaches they experience, as well.
The FTC is required to pass regulations related to vendors covered under the Act within 180 days. If, however, Congress passes breach notification laws that directly apply to vendors, then the breach notification provisions of the Act will be overridden. While this provision may be good housekeeping to prevent dual breach notification laws for vendors, it may also be a sign of further breach notification legislation to come from Congress.
II. Marketing, Sale of Protected Healthcare Information, and the Minimum Necessary Standard
The Act has several provisions that restrict marketing activities and create greater privacy protections for individuals. Covered entities will need to revise their privacy practices to accommodate their new responsibilities.
The Act reduces the amount of marketing activities allowed under HIPAA. Communication by covered entities or business associates that is about a product or service and that encourages recipients to purchase or use the product or service are not considered a health care operation under HIPAA unless they are made 1) to describe a health-related product or service, 2) for treatment of the individual, or 3) for case management or care coordination for the individual. If, however, the covered entity or business associate receives direct or indirect payment in exchange for the communication, then the communication is considered marketing. On the other hand, such a communications will still be considered to be a healthcare operation if it describes a drug that the recipient is using and the payment received is reasonable. The Secretary is charged with defining the amount of reasonable compensation through regulations. However, such communication must still be made with a valid authorization. The Act also prohibits the sale of protected health information without a valid authorization. The regulations for these authorization do not change under the Act.
The Act now makes it mandatory to comply with an individual’s request that the entity restrict the use and disclosure of protected health information about the individual to carrying out treatment, payment, or healthcare operations. Prior HIPAA regulations did not require covered entities to agree to such restrictions.
Individuals also have the right to access protected health information in electronic format if the entity maintains that information. The fee for such access cannot exceed labor costs in responding to the request.
Under HIPAA, an entity was required to make reasonable efforts to limit protected health information to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request of that information. The Act further reduces the amount of data in circulation by requiring the Secretary to promulgate regulations based on the limited data set concept that excludes identifiers such as names, addresses, social security numbers, email addresses and similar information to the extent practicable. Such changes will certainly require that covered entities revisit their privacy practices.
III. Fines and Enforcement
The Act also promotes enhanced enforcement through required fines and investigations.
Violations due to willful neglect now require a fine by the Secretary. Furthermore, the Secretary now has an obligation to investigate any complaint of a violation of the Act if a preliminary investigation of the facts of the complaint indicate a possible violation due to willful neglect. Most importantly, the Act requires that any civil monetary fine or settlement fund collected relating to privacy and security be transferred to the Office for Civil Rights of the DHHS. This provision will likely create a positive feedback loop where enforcement will result in fines and settlements that will give the OCR more funds to carry out more investigations. Additionally, individuals harmed by such breaches may also receive a percentage of the funds received by the OCR, but this amount will be determined three years from the date of the enactment. The Act also creates four tiers of penalties for different levels of culpability ranging from $100 to $50,000 for each violation that are not to exceed $25,000 to $1,500,000 during a calendar year. These fines are effective immediately.
The law can also be enforced by the State Attorneys General. If there is reason to believe that the interests of one or more of the residents of the State is or could be threatened, then the AGs may bring action in federal district court. The courts can, in their discretion, award attorneys fees to the AGs that bring action in federal district courts. However, such state action is limited to circumstances where the Secretary is not already bringing an action. Considering the availability of attorneys fees and the public record of breaches, it is likely that this provision will increase enforcement in cases where the FTC or the DHHS decline enforcement.
IV. Joint Enforcement and CVS’s $2.25 million DHHS Fine
The day after the Act was signed into law, the FTC and the DHHS announced separate settlements with the nationwide pharmacy chain CVS arising out of improper disposal of sensitive personal information. The settlement is significant because it is the first joint investigation by the FTC and the DHHS, involves a health provider, and employee data. Moreover, due to the language of the Act and the cooperation required between the two organizations, it is likely to be a sign of more joint investigations to come.
According to the FTC complaint, during 2006 and 2007 television stations found evidence of CVS’s disposal of names, addresses, dates of birth, bank account numbers, physicians’ names, insurance account numbers and other personal information in unsecured dumpsters in at least 15 cities. Seizing on CVS’s statements that “nothing is more central to our operations than maintaining the privacy of your health information” and that CVS took “this responsibility very seriously,” the FTC argued that CVS’s representations in its notice of privacy practices were false and misleading, likely to cause substantial injury to consumers; therefore, an unfair act or practice. As a result, CVS settled with the FTC and the DHHS in separate settlement agreements.
The FTC settlement is very similar to the other settlements that FTC reached with ChoicePoint, DSW, and TJ Maxx. CVS must create a comprehensive information security program, designate an accountable employee for that program, identify risks, and receive third party assessments of its security procedures for the next 20 years. It is the 24th FTC case that challenges a company’s failure to implement reasonable information security practices.
The DHHS settlement is similar but probably more significant. Under the resolution agreement with the OCR, CVS agreed to pay $2.25 million and implement a robust corrective action plan that includes safeguards for disposal, employee training, and employee sanctions for noncompliance. CVS must comply with this action plan for the next three years, followed by the FTC settlement’s two decade long program. The DHHS Office of Civil Rights press release on the resolution agreement highlights the OCR’s intention to make an example of CVS and its “commitment to strong enforcement of HIPAA Privacy Rule . . . [intended to] spur other health organizations to examine and improve their privacy protections.” The DHHS settlement is the second one of its kind. The previous resolution agreement was with Providence Health Information for $100,000. While the OCR conducts investigations and allows entities to correct HIPAA problems, it had not issued fines of this magnitude.
Vendor breach notifications under the Act will likely spur closer cooperation between the two agencies. OCR’s new obligation to assess fines, conduct investigations in certain cases, and its ability to keep the fines it issues will result in OCR having more resources and incentives to enforce the law. This positive feedback loop will likely result in the FTC and the OCR enforcing the requirements of HIPAA and publicizing them in the future. Therefore, the CVS settlement should provide an incentive for entities of all sizes to satisfy not only their current HIPAA obligations but also their future breach notification requirements.
The Recovery and Reinvestment Act creates broad data breach notification requirements for covered entities, business associates, and vendors on a federal level under HIPAA. These entities will need to abide by the regulations that the Secretary of the DHHS will promulgate in the next six months. Further, they will need to abide by the breach notification rules or face fines and settlements by both the FTC and the OCR. Therefore, affected organizations should act quickly to update their breach response plans, revise their privacy policies, stop sales of protected health information without appropriate authorization, and update business associate agreements.