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Modern conveniences from washing machines to GPS simplify our lives. In healthcare, however, new technology has not always streamlined delivery. A prime example is the introduction of Electronic Health Records (EHRs) over the...more
The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...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
The health care industry is increasingly adopting mobile apps for a variety of purposes, including tracking patient health conditions and sharing patient data. Privacy and security are important considerations, and it is...more
The FTC is closing out 2022 with additional guidance for mobile health app developers signaling its continued interest in this industry. Since 2021, we have seen several steps from the agency demonstrating a focus on...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...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
It is increasingly important for mobile app developers to ensure their products comply with all governing state and federal laws, and it is critical to understand which business changes might place your product under a...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices - Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG - The wearable device market is emerging as a key player...more
Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our second “Public Policy Weekly* Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more
This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps...more
How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more
This month, the Federal Trade Commission (FTC) issued guidance on privacy and security best practices for health-related mobile apps, such as fitness apps connected with wearables, diet and weight loss apps, and health...more
Consider this: A 42-year-old man arrives at the emergency room showing signs of a heart attack. The ER doctors, using the patient’s activity tracker—in this case, a Fitbit® —are able to pinpoint when the patient’s normal...more
While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more
Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of...more