When use or disclosure of an individual’s health information or medical records is at issue, the assumption seems to be, much more often than not, that the HIPAA privacy and security rules apply. This has certainly been the case during the COVID-19 pandemic. Of course, it is true that in most healthcare settings, HIPAA is

Roger Severino, Director of the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS), provides advice for HIPAA covered health care providers:

When informed of potential HIPAA violations, providers owe it to their patients to quickly address problem areas to safeguard individuals’ health information

According to OCR allegations,

The Office for Civil Rights (OCR) has been moving swiftly to provide guidance on addressing key regulatory issues to aid in the fight to contain and defeat COVID-19. Some of the latest developments include exercising its enforcement discretion on certain good faith disclosures of protected health information (PHI) by business associates, adding FAQs for telehealth

With first responders on the front lines of helping to fight the coronavirus, sharing information about potential exposure to COVID-19 is critical to protecting them and preventing further spread. In these situations, the information shared is most often “protected health information” (PHI) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule.

The Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) wants to make it easier for individuals to reach a healthcare provider, including those most at risk (older persons and persons with disabilities). Effective immediately, during the COVID-19 nationwide public health emergency, OCR announced it will not enforce noncompliance with

As the coronavirus spreads across the globe and in the United States, providers, businesses, employers, and others are struggling to understand what medical information they can collect and what information they can share. These are difficult questions the answers to which involve considering factors such as long-standing compliance requirements (e.g., HIPAA, ADA, GINA, state law), the unprecedented times we are in, business risk, and common sense. Government is trying to act to relieve some of these challenges, but questions still remain.

HIPAA Privacy Rule Waiver of Penalties and Sanctions

Effective March 15, 2020, for example, Secretary of the U.S. Department of Health and Human Services (HHS) Alex M. Azar (Secretary) waived certain penalties and sanctions under the HIPAA Privacy Rule against hospitals in its March 2020 COVID-19 and HIPAA Bulletin. These waivers were issued in response to President Donald J. Trump’s declaration of a nationwide emergency concerning COVID-19, and the Secretary’s earlier declaration of a public health emergency on January 31, 2020. The Secretary’s guidance makes clear that the Privacy Rule is not suspended during this crisis and provides guidance about the ability of entities covered by the HIPAA regulations to share information, including with friends and family, public health officials, and emergency personnel. But, in the following areas, the Secretary has waived sanctions and penalties against covered hospitals that do not comply with the following provisions of the HIPAA Privacy Rule:

  • the requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care. See 45 CFR 164.510(b).
  • the requirement to honor a request to opt out of the facility directory. See 45 CFR 164.510(a).
  • the requirement to distribute a notice of privacy practices. See 45 CFR 164.520.
  • the patient’s right to request privacy restrictions. See 45 CFR 164.522(a).
  • the patient’s right to request confidential communications. See 45 CFR 164.522(b).

The waiver became effective on March 15, 2020, and there is more information and access to resources in the Bulletin about where it applies and for how long.

Reminder About What Entities Are Covered Entities and Business Associates

As part of its guidance on HIPAA privacy and disclosures in emergency situations, the Bulletin reminds readers what entities are covered by these rules – covered entities and business associates. There can be some tricky questions here, but these are the basic rules from the Bulletin:

The HIPAA Privacy Rule applies to disclosures made by employees, volunteers, and other members of a covered entity’s or business associate’s workforce. Covered entities are health plans, health care clearinghouses, and those health care providers that conduct one or more covered health care transactions electronically, such as transmitting health care claims to a health plan. Business associates generally are persons or entities (other than members of the workforce of a covered entity) that perform functions or activities on behalf of, or provide certain services to, a covered entity that involve creating, receiving, maintaining, or transmitting protected health information. Business associates also include subcontractors that create, receive, maintain, or transmit protected health information on behalf of another business associate. The Privacy Rule does not apply to disclosures made by entities or other persons who are not covered entities or business associates (although such persons or entities are free to follow the standards on a voluntary basis if desired). There may be other state or federal rules that apply.

Employers are Not Covered Entities or Business Associates – But Still Have Privacy and Confidentiality Obligations

When conducting its business, an organization can be a HIPAA covered entity and/or a business associate. However, when that business is functioning as an employer, it is neither a HIPAA covered entity nor a business associate, although it may sponsor a covered health plan subject to the HIPAA privacy and security rules. As organizations face the coronavirus threat to their workforce and their business, many questions arise about the collection, processing, and disclosure of medical information from employees, their family members, and visitors to their facilities. These can be thorny questions and organizations should seek qualified counsel, but here are some general rules:

When may an ADA-covered employer take the body temperature of employees during the COVID-19 pandemic?
Continue Reading HIPAA Privacy Rule Waiver, Other Medical Information Questions During the COVID-19 Pandemic

Over the past few months, businesses across the country have been focused on the California Consumer Privacy Act (CCPA) which dramatically expands privacy rights for California residents and provides a strong incentive for businesses to implement reasonable safeguards to protect personal information. That focus is turning back east as the Stop Hacks and Improve Electronic Data Security Act (SHIELD Act), becomes effective in less than two weeks. With the goal of strengthening protection for New York residents against data breaches affecting their private information, the SHIELD Act imposes more expansive data security and updates its existing data breach notification requirements.

This post highlights some features of the SHIELD Act. Given the complexities involved, organizations would be well-served to address their particular situations with experienced counsel.

When does the SHIELD Act become effective?

The SHIELD Act has two effective dates:

  • October 23, 2019 – Changes to the existing breach notification rules
  • March 21, 2020 – Data security requirements

Which businesses are covered by the SHIELD Act?

The SHIELD Act’s obligations apply to “[a]ny person or business which owns or licenses computerized data which includes private information” of a resident of New York. Previously, the obligation to provide notification of a data breach under New York’s breach notification law applied only to persons or businesses that conducted business in New York.

Are there any exceptions for small businesses?

As before the SHIELD Act, there are no exceptions for small businesses in the breach notification rule. A small business that experiences a data breach affecting the private information of New York residents must notify the affected persons. The same is true for persons or businesses that maintain (but do not own) computerized data that includes private information of New York residents. Persons or businesses that experience a breach affecting that information must notify the information’s owner or licensee.

However, the SHIELD Act’s data security obligations include some relief for small businesses, defined as any person or business with:
Continue Reading New York SHIELD Act FAQs

Many health care providers, including small and medium-sized physician practices, rely on a number of third party service providers to serve their patients and run their businesses. Perhaps the most important of these is a practice’s electronic medical record (EMR) provider, which manages and stores patient protected health information. EMR providers generally are business associates

When the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 became law, it made significant changes to the civil monetary penalties for violations of HIPAA. In addition to increasing the amounts of the penalties, HITECH created a tiered approach to penalties, establishing four categories based on levels of culpability. In addition,

Small and midsized enterprises (SMEs) continue to be targeted by ransomware, phishing and other cyberattacks; the consequences of which could be devastating. Those consequences include putting SMEs out of business, which is unfortunately the case for one small medical practice in Battle Creek, Michigan, as reported by HIPAAJournal.

The reality is that the effects