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Medical Device Legal News with Sam Bernstein: Episode 19
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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
On March 18, 2024, the Office for Civil Rights ("OCR") at the U.S. Department of Health and Human Services ("HHS") published updated guidance on the use of online tracking technologies by HIPAA covered entities and business...more
On January 25, 2024, HHS Office for Civil Rights (OCR) issued guidance and responses to frequently asked questions regarding nondiscrimination regulations related to patient visitation. Hospitals, long term care facilities,...more
The U.S. Department of Health and Human Services (HHS) recently issued a strategy paper highlighting key aspects of its plan to revamp cybersecurity requirements in the healthcare industry. Citing a 93% increase in large data...more
On November 6, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released the most up-to-date, comprehensive, and practical general compliance guidance in decades. The new...more
On October 18, 2023, the Department of Health and Human Services (DHHS) through the Office for Civil Rights (OCR) issued an update1 containing two resource documents to help educate patients regarding privacy and security...more
On October 18, 2023, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”), which is tasked with enforcing the Health Insurance Portability and Accountability Act (“HIPAA”), issued two new...more
The COVID-19 public health emergency (PHE) in the United States came to an end on May 11, 2023. Simultaneously, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced that its enforcement...more
The Notifications of Enforcement Discretion issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act during the...more
The U.S. Department of Health and Human Service’s Office of Civil Rights (“OCR”) has announced that several notifications of enforcement discretion issued during the COVID-19 public health emergency (“PHE”) will expire...more
A patient surfs a hospital system’s website and reads an article about depression and anxiety. The patient then searches the hospital’s website for mental health providers in the area. A few hours later, the patient logs into...more
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued guidance regarding covered entities’ and business associates’ use of tracking technologies (the Guidance). As discussed in greater detail...more
On December 1, 2022, the Centers for Medicare and Medicaid Services’ Office of Civil Rights (OCR) issued new guidance to covered entities and business associates regarding website and application user data tracking and how...more
Covered Entities and Business Associates must comply with HIPAA in their use of online tracking technologies, including cookies, pixels or similar code. The U.S. Department of Health and Human Services (HHS), Office for Civil...more
On December 1, 2022, the Office for Civil Rights (OCR) at the US Department of Health and Human Services (HHS) issued a Bulletin on the obligations of covered entities and business associates (regulated entities) under the...more
Most companies operating websites and mobile apps use some form of tracking technologies on these digital properties. While these types of technologies have been used for some time and serve a variety of purposes, the use of...more
For years, patients and healthcare companies have been wrestling with privacy issues relating to cookies, pixels and other tracking technologies. The U.S. Department of Health and Human Services' (HHS) Office of Civil Rights...more
In June 2022, the HHS Office for Civil Rights issued new HIPAA Privacy Rule Guidance in response to the Supreme Court’s decision in Dobbs v Jackson Women’s Health Organization and state legislation which followed the decision...more
The ripple effect from the U.S. Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization has prompted the federal Office of Health and Human Services (HHS) to reinforce core principles of privacy compliance. HHS...more
In response to the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, the U.S. Department of Health and Human Services (“HHS”) Secretary Xavier Becerra directed HHS agencies to act within their power to...more
On July 8, President Biden signed an executive order for abortion access. In this order, the US Department of Health and Human Services (HHS) pledged to take steps to ensure that all patients have access to the full rights...more
On July 13, the Department of Health & Human Services (HHS) Office for Civil Rights (OCR) issued guidance to retail pharmacies that refusing to dispense a prescribed medication or making a determination on the suitability of...more
In the wake of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, many individuals and organizations have expressed uncertainty about the protection afforded to data stored on health apps,...more
In the wake of the Dobbs decision, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued new guidance regarding the privacy of patients seeking reproductive health care. The guidance...more
In the two weeks following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, the Biden Administration has taken several actions to provide clarity about women’s access to reproductive health...more