On September 15, 2021, the Federal Trade Commission (FTC) issued a Policy Statement cautioning that health apps and connected devices that collect or use consumers’ health information must comply with the Health Breach Notification Rule and notify consumers when their health data is breached.
The Health Breach Notification Rule (codified at 16 C.F.R. § 318) protects individually identifiable health information created or received by vendors of personal health records. The Rule requires vendors of personal health records to notify U.S. consumers, the FTC, and sometimes the media when there has been a breach of security of unsecured identifiable health information. Persons that fail to comply with the Rule may be subject to monetary penalties of up to $43,792 per violation, per day.
The Health Breach Notification Rule became effective in 2009, but the FTC has not enforced it to date. However, because health care applications continue to proliferate and to collect increasingly personal and sensitive health information, the FTC issued this Policy Statement to place health apps on notice that the Rule will be enforced going forward and to clarify that they are considered to be “vendors of personal health records” covered under the Rule.
The FTC explains that the developer of a health app or connected device is considered a “vendor of personal health records” under the Rule if it is capable of drawing information from multiple sources, such as a combination of direct inputting by a consumer, syncing with a consumer’s fitness tracker, or even interfacing with the phone calendar. The Rule does not apply to vendors of personal health records who are already covered by HIPAA.
In addition, the FTC reminds vendors of personal health records that a “breach of security” is not limited to cyberattacks by third parties, but includes any acquisition of identifiable health information of an individual in a personal health record without the individual’s authorization. The FTC states that “[i]ncidents of unauthorized access, including sharing of covered information without an individual’s authorization, triggers notification obligations under the Rule.”
If a breach occurs, then health apps should examine state data breach notification laws to determine if they apply as well.
On September 30, 2021, the Office for Civil Rights (OCR) issued welcome guidance concerning when the Health Insurance Portability and Accountability Act of 1996 (HIPAA) applies to disclosures and requests for information about whether a person has received a COVID-19 vaccine—and when it does not apply.
The guidance aims to clear up misperceptions about who can ask questions about vaccination. In general, OCR reminds that HIPAA only applies to HIPAA covered entities, such as health care providers (physicians, hospitals, etc.) and health plans, and it does not apply to employers or employment records. The guidance addresses common workplace situations, provides helpful examples, and answers frequently asked questions for HIPAA covered entities, businesses, and the public.
HIPAA does not prohibit businesses, individuals, or HIPAA covered entities from asking whether their customers or clients have received a COVID-19 vaccine. HIPAA does not prohibit any person, whether an individual or a business or a HIPAA covered entity, from asking individuals whether they have received a COVID-19 vaccine. First, OCR makes it clear that HIPAA only applies to HIPAA covered entities, and it does not apply to other individuals or entities. Second, even though HIPAA regulates how and when HIPAA covered entities may use or share information about COVID-19 vaccinations, it does not limit the ability of covered entities to ask patients or visitors whether they have been vaccinated.
The guidance clarifies that HIPAA does not apply when an individual:
Is asked about their vaccination status by a school, employer, store, restaurant, entertainment venue, or another individual.
Asks another individual, their doctor, or a service provider whether they are vaccinated.
Asks a company, such as a home health agency, whether its workforce members are vaccinated.
HIPAA generally prohibits a physician from telling the individual’s employer or others whether an individual has received a COVID-19 vaccine. HIPAA prohibits covered entities from using or sharing an individual’s protected health information (PHI), such as whether they have received a COVID-19 vaccine, unless the individual authorizes the disclosure or it is permitted by HIPAA.
The guidance provides some scenarios where a covered entity is permitted under HIPAA to disclose information about COVID-19 vaccination without the patient’s authorization. For example:
A physician may disclose information relating to an individual’s vaccination to the individual’s health insurance in order to obtain payment for administering a COVID-19 vaccine.
A pharmacy may disclose information relating to an individual’s vaccination status to a public health authority, such as a state or local public health department.
A hospital may disclose information relating to an individual’s vaccination status to the individual’s employer in order to permit the employer to evaluate the spread of COVID-19 within the workforce or to determine whether the individual has a work-related illness, if the employer needs the findings in order to comply with its obligations under the legal authorities of the Occupational Safety and Health Administration (OSHA), the Mine Safety and Health Administration (MSHA), or similar state laws.
In other circumstances, HIPAA generally requires a covered entity to obtain an individual’s written authorization before disclosing information about vaccine status to, for example, a sports arena, hotel, cruise ship, or airline.
HIPAA does not prohibit an employer from requiring an employee to disclose whether they have received a COVID-19 vaccine to the employer, clients, or other parties. HIPAA does not apply to employers and employment records. Consequently, HIPAA does not regulate what information employers can request from employees. Employers may require that all employees physically entering the workplace be vaccinated against COVID-19 and provide documentation that they have met this requirement without violating HIPAA. Employers may also require the employee to share this information with clients and others. However, when requiring employees to obtain vaccinations and documentation of vaccination as a condition of employment, employers should ensure that these requirements comply with other federal or state laws, such as the Americans with Disabilities Act (ADA).
HIPAA does not prohibit a HIPAA covered entity from requiring members of its workforce to disclose to their employers or other parties whether they have received a COVID-19 vaccine. HIPAA does not apply to employers—including HIPAA covered entities in their role as employers—and employment records. Similar to other employers, HIPAA covered entities may require their employees, volunteers, contractors and other members of their workforce to be vaccinated against COVID-19 and to disclose whether they have been vaccinated to their employer, other workforce members, patients, or members of the public.
OCR also sets the record straight that HIPAA does not prohibit a covered entity from requiring or requesting each member of the workforce to:
Provide documentation of their COVID-19 or flu vaccination to their current or prospective employer.
Sign a HIPAA authorization for a covered health care provider to disclose the workforce member’s COVID-19 or varicella vaccination record to their employer.
Wear a mask–while in the employer’s facility, on the employer’s property, or in the normal course of performing their duties at another location.
Disclose whether they have received a COVID-19 vaccine in response to queries from current or prospective patients.
As noted above, other federal and state laws, such as the ADA, may limit or affect the HIPAA covered entity’s use of this information.
HIPAA does not prevent individuals from choosing to disclose whether they have received a COVID-19 vaccine. HIPAA does not apply to individuals’ disclosures about their own health information. It applies only to HIPAA covered entities. Therefore, HIPAA does not apply when an individual tells another person, such as a colleague or business owner, about their own vaccination status.
This long-overdue guidance addresses the misunderstandings about the application of HIPAA to questions about COVID-19 vaccinations by employers, businesses and others.
In light of the escalation in ransomware and other cyber threats, a bi-partisan group of U.S. Senators has released a cybersecurity notification bill titled “Cyber Incident Notification Act of 2021.” Under the proposed bill, a “covered entity” would be required to report a “cybersecurity intrusion” or “potential cybersecurity intrusion” to the Cybersecurity and Infrastructure Security Agency (CISA) within 24 hours of confirmation of the intrusion. Covered entities also would be required to submit updated cybersecurity threat information to CISA within 72 hours after the discovery of new information. The requirement for updates would continue until the incident is mitigated or any follow-up investigation is completed.
Although the term “cybersecurity intrusion” would be defined in future rulemaking with public comment, the bill provides, at a minimum, that the term include ransomware if it falls into one of six broad categories. The categories include ransomware involving a nation-state, an advanced persistent threat cyber actor, or a transnational organized crime group. The categories also include ransomware that results in or has the potential to result in harm to national security interests, the U.S. economy, or to public confidence, civil liberties, or public health and safety. In essence, it would encompass most types of ransomware.
The term “covered entity” also is to be defined by future rulemaking but, per the bill, “shall include, at a minimum, Federal contractors, owners or operators of critical infrastructure, as determined appropriate by the Director based on assessment of risks posed by compromise of critical infrastructure operation, and nongovernmental entities that provide cybersecurity incident response services.” CISA’s list of critical infrastructure sectors include: Information Technology, Communications, Healthcare and Public Health, Emergency Services, Financial, Energy, Food and Agriculture, Commercial Facilities, Critical Manufacturing, among others. For a full list of CISA’s current “critical infrastructure” sectors and a detailed discription of each, click here.
To incentivize compliance, the law would allow the CISA Director to assess a civil penalty up to 0.5 percent of the entity’s gross revenue from the prior year for each day it violates the requirements under the law or under rules promulgated under the law. The Director would be allowed to “take into account mitigating or aggravating factors, including the nature, circumstances, extent, and gravity of the violations and, with respect to the covered entity, the covered entity’s ability to pay, degree of culpability, and history of prior violations.”
By: Courtney Samford, contributing author Blake Sims, Wyatt Summer Associate
Employers commonly supply computer and work devices to employees and state that the electronics may only be used for business related purposes, and employers have always had the ability to discipline employees who violate computer use policies through improper use. In some Federal Court of Appeals Circuits, employers may have been able to rely on threats of criminal and civil liabilities under 18 U.S.C. § 1030 to further deter improper use. On June 3, 2021, however, an evenly split conservative-liberal majority of the Supreme Court reversed the Eleventh Circuit Court of Appeals in Van Buren v. United States, holding that an individual only violates the Section 1030 of Computer Fraud and Abuse Act “when he accesses a computer with authorization but then obtains information located in particular areas of the computer—such as files, folders, or databases—that are off limits to him.” Van Buren v. United States, No. 19-783 (Sup. Ct. June 3, 2021).
The Information Blocking Final Rule, a provision of the 21st Century Cures Act geared towards ensuring access, exchange and use of electronic health information (EHI), was published on May 1, 2020, and became effective on June 20, 2020. However, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health IT (ONC) extended the compliance effective dates for the Final Rule several times over the last year—and most providers were hopeful that it would be extended once again—but there are no more delays. Information Blocking compliance is now effective, as of April 5, 2021. Health care providers should take immediate steps to ensure compliance.