On 16 February 2024, the Supreme Court of Alabama published its opinion, “Supreme Court of Alabama, SC-2022-0515,” regarding whether embryos located outside the biological uterus are considered unborn children pursuant to...more
In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving...more
In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving...more
3/27/2024
/ Cyber Attacks ,
Cyber Threats ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Telehealth
Almost one year ago, Washington State passed the “My Health, My Data” Act (the Act), which aims to protect Washington consumer health data, particularly data related to reproductive healthcare. The Act is the first law in the...more
What You Need to Know in a Minute or Less - The use of pixel technologies on websites and mobile apps in the health care field has garnered considerable attention from regulators and the plaintiffs’ class action bar....more
On 27 June 2023, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) posted its long-awaited final rule (CMP Final Rule) related to the federal information blocking regulations and the...more
Executive Summary - The Drug Enforcement Administration (DEA) issued a temporary rule (Temporary Rule), effective 11 May 2023, extending flexibilities regarding the prescribing of controlled substances via telemedicine that...more
SUMMARY - On 27 April 2023, Washington Gov. Inslee signed into law House Bill 1155, referred to as the “My Health, My Data” Act (the Act), which takes effect on 31 March 2024. The Act aims to protect Washington consumer...more
SUMMARY - The US Department of Health and Human Services’ Office for Civil Rights (HHS) is proposing changes to the Privacy Rule under the Health Insurance Portability and Accountability Act (HIPAA). HHS's proposed changes...more
On 10 March 2023, the U.S. Department of Justice (the DOJ) appealed to the Fifth Circuit Court of Appeals an amended final decision by the Northern District of Texas (the Texas District Court) that struck down U.S. Department...more
On 29 December 2022, President Biden signed into law the Consolidated Appropriations Act of 2023 (the Act), allocating US$1.7 trillion in government spending. The Act contains hundreds of pages of legislation on a myriad of...more
BACKGROUND - As we noted in prior health care alerts in 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) significantly overhauled the federal law that governs the confidentiality of substance use...more
In this episode, Gina Bertolini and Stephen Page discuss the most recent Information Blocking Rule compliance deadline. Using a recent letter from several health care providers and other stakeholders to the Office of the...more
On 28 June 2022, in the wake of the U.S. Supreme Court’s ruling in Dobbs vs. Jackson Women’s Health Organization, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra directed the Office for Civil...more
In this episode, Rebecca Schaefer and Gina Bertolini discuss the incredible value of health care data and how providers can harness the power of data transactions to drive innovation, discovery, and advancements in medical...more
As the explosion of telemedicine continues during and, as many expect, after the COVID-19 public health emergency (PHE), state laws and regulations that affect the delivery of telemedicine services continue to expand and...more
As the explosion of telemedicine continues during and, as many expect, after the COVID-19 public health emergency, state laws and regulations that affect the delivery of telemedicine services continue to expand and contract....more
Desiree Moore, Gina Bertolini, and Jackie Hoffman discuss the increasing impact of data security incidents and security breaches on the health care sector. They define what qualifies under HIPAA as a protected health...more
1/21/2022
/ Cyber Incident Reporting ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Incident Response Plans ,
OCR ,
PHI ,
Popular
This final article in our four-part series examines other relevant laws digital health providers and suppliers should know. If you missed our earlier articles, you can read about HIPAA in Part I and Part II, and the FDCA and...more
This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act (FDCA), as well as regulatory issues unique to non-US companies. ...more
In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application...more
Digital health technologies are revolutionizing the global health environment by advancing healthcare services, Big Data analytics and medical device development and innovation, expanding the reach, accessibility and...more
In this episode, Rebecca Schaefer interviews Gina Bertolini and Desiree Moore about the recent Federal Trade Commission (FTC) policy statement regarding the FTC Health Breach Notification Rule and its applicability to vendors...more
10/7/2021
/ Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Records ,
Mobile Health Apps ,
PHI ,
Policy Statement ,
Vendors
As health care providers are increasingly relying on complex and integrated electronic medical record systems, the health care industry has rapidly become one of the most frequent and often vulnerable targets for...more
8/9/2021
/ Cyber Attacks ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
PHI ,
Popular ,
Risk Management
On 29 April 2021, Senator Brian Schatz (D-HI) reintroduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, S. 1512 (the Act). The bill, which currently has 59...more