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
Nick Culbertson on Compliance Breaches in Healthcare
Privacy Series: HIPAA Breaches - When It Is, and When It Is Not a Breach
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
Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more
As healthcare technology continues to evolve, so does the need for robust compliance strategies to safeguard patient information and ensure the integrity of medical devices. In a joint September 19, 2024 presentation, the...more
...Innovation in connected medical devices is critical to advances in health care outcomes, user experience, and reducing costs. These exciting technologies also can be challenging when it comes to navigating the complex...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
With its trove of sensitive patient and personal data and increasingly digitized records, the health care industry is always vulnerable to cyberattacks and data breaches. But in light of Russia’s invasion of Ukraine and...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
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...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
Beware of “Most Favored Nations” Clauses in Commercial Contracts - Imagine that your digital health company has developed a groundbreaking product. You are eager to monetize the product, so you sign non-disclosure...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
The U.S. Food and Drug Administration (FDA) recently issued a dense, 24-page draft guidance, titled "Content of Premarket Submissions for Management of Cyber Security in Medical Devices" (the guidance). The guidance notes...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
From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...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
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
Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design...more