Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
Key Discovery Points: Don’t Get Caught with Your Hand in the Production Cookie Jar
New Developments in Health Information Policy
New HIPAA Final Rule: Key Changes to Reproductive Health Care Privacy - Thought Leaders in Health Law®
Podcast - Data Privacy and Tracking Technology Compliance
Medical Device Legal News with Sam Bernstein: Episode 10
AI Risks in Healthcare
Business Associates Here, There, and Everywhere: When Does Your Service Provider Really Need to Sign a HIPAA Business Associate Agreement?
Healthcare Privacy Walkthroughs
Dobbs on Demand: Healthcare Privacy on the Line in a New Legal Setting
HIPAA Tips With Williams Mullen - Health Care Providers - Are You Ready for a Ransomware Attack?
Hybrid Workforces and Compliance with Sheila Limmroth
Privacy and Healthcare Business Associates with Isabella Porter
Podcast: Interoperability: The Provider Perspective - Diagnosing Health Care
HIPAA Tips With Williams Mullen - COVID Health Information and HIPAA – Do You Know the Rules?
Podcast–Interoperability: How Far We’ve Come and Where We’re Going - Diagnosing Health Care
State Law Privacy Video Series | Healthcare Entities and Health Data
Getting Personal—Wearable Devices, Data, and Compliance
AGG Talks: Technology - In the Balance: Interoperability and Security
Podcast: How Can Companies in the Health Care and Life Sciences Industries Strengthen Their Cybersecurity Posture? - Diagnosing Health Care
Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more
The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more
Report on Patient Privacy 22, no. 9 (September, 2022) - More than 92% of patients believe privacy is a right and their health data should not be available for purchase, according to a survey from the American Medical...more
In a previous issue of Decoded, we discussed the alarming fact that many medical devices, including those implanted in patients' bodies, are leaving the manufacturers with known cybersecurity flaws. Due to these known flaws,...more
Report on Patient Privacy 22, no. 3 (March, 2022) - Typically a “legacy” describes the lasting impact of an influential person or movement, most often in a positive sense. Not so with medical devices. When legacy is applied...more
Report on Patient Privacy 22, no. 1 (January, 2022) - As the COVID-19 pandemic enters its third year, real “security fatigue” with pandemic-related issues will combine with cybercriminals’ increasingly sophisticated...more
The Pandemic has fast-tracked the use of telehealth services. Hussein Akhavannik discusses how medical device companies are looking to add to or expand remote monitoring capabilities. However, some capabilities raise legal...more
The United States is experiencing an unprecedented shutdown affecting almost all aspects of life due to the current pandemic. To speed relief to the economy, on March 27, 2020, Congress enacted the Coronavirus Aid, Relief,...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
Q: How is the shift of medical devices moving to the Internet of Things affecting the health care industry? A: Connected medical devices routinely record sensitive health information about a patient. This critical...more
• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more
Cisco Talos has discovered a new menace to iPhone users—a sophisticated malware campaign targeting iPhones to trick users into downloading an open-source Mobile Device Management (MDM) solution that gives the hackers control...more
“Orangeworm” Targeting Health Care Industry - In what is being called a systematic targeting of large health care organizations, pharmaceutical companies, and IT companies and equipment manufacturers that service the...more
On January 4, 2018, the National Health Information Sharing and Analysis Center (NH-ISAC) posted an announcement regarding the cybersecurity threats Meltdown and Spectre that were recently identified....more
I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more
New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more
On October 21-22 the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Departments of Health and Human Services and Homeland Security, conducted a public workshop entitled “Collaborative Approaches for...more