Author: Margaret Young Levi

CMS Issues Updated Guidance on Texting Patient Orders

Margaret Young Levi Cyber Security and Cyber Crime, Data Privacy & Security, Electronic Health Records, Health Information Technology, HIPAA, Privacy & Security , , , , , , , , , ,

By: Margaret Young Levi

On February 8, 2024, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum entitled Texting of Patient Information and Orders for Hospitals and CAHs (the 2024 Memo), which provides updated guidance to State Survey Agency Directors.  This 2024 Memo now permits the texting of patient orders among members of the hospital care team—if the texting is accomplished on a secure platform that protects the privacy and integrity of the patient information. 

This new guidance updates CMS’ previous memorandum entitled Texting of Patient Information among Healthcare Providers in Hospitals and Critical Access Hospitals (CAHs) (the 2017 Memo), which permitted texting patient information if done through a secure platform, but prohibited texting of patient orders regardless of the platform utilized.

Even though texting of patient orders through a secure platform is now permitted by CMS, that does not mean it is recommended.  CMS still prefers that providers enter their orders into the medical record via computerized provider order entry (CPOE) or even a handwritten order because of concerns about medical record retention, accuracy, privacy and security, etc. as set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Medicare Conditions of Participation (CoPs), and, if applicable, The Joint Commission (TJC) standards discussed below.

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Breach Notification Deadline is February 29th

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By: Margaret Young Levi

Head’s up!  The deadline for notifying the Office for Civil Rights (OCR) of healthcare data breaches affecting fewer than 500 individuals is early this year.  Reports of small data breaches may be submitted to OCR annually, usually on March 1st, but because 2024 is a leap year, the reports are due on or before Thursday, February 29th. 

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FTC Warns That Health Apps Must Notify Consumers of Data Breaches

Margaret Young Levi Data Privacy & Security , ,

By: Margaret Young Levi

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. 

OCR Issues Guidance on HIPAA, COVID-19 Vaccination and the Workplace

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By: Margaret Young Levi

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.
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OCR Settlement a Message to Providers: Every Day Counts to Notify Affected Persons After a HIPAA Data Breach

Margaret Young Levi Data Privacy & Security, HIPAA, Privacy & Security , , , ,

The U.S. Department of Health & Human Services, Office of Civil Rights (OCR) entered into a settlement with Presence Health Network relating to its failure to provide timely notification of a breach of unsecured protected health information under the Health Insurance Portability & Accountability Act (HIPAA). OCR data breach settlements typically concern a covered entity’s failure to properly secure protected health information; this marks the first settlement involving a provider’s failure to report a data breach in a timely manner.

Under the HIPAA Breach Notification Rules, covered entities must provide notification of a breach without unreasonable delay and in no case later than 60 days following the discovery of a breach to affected individuals, and, in breaches affecting more than 500 individuals, to OCR and the media.

Presence Health is a not-for-profit health system serving 150 locations in Illinois. Presence Health first discovered that some paper copies of its surgery schedules at one location were missing on October 22, 2013, and these documents contained the protected health information of 836 individuals. The information consisted of the Continue reading →