Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 232: Commercial Real Estate for Life Sciences Companies with Vinnie Durand of Savills
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 229: Public Health in South Carolina with Dr. Edward Simmer of SC Dept of Public Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 227: What’s Next for America’s Life Sciences Industry with Arda Ural of EY
Taking the Pulse, A Health Care and Life Sciences Video Podcast | SCbio 2025 Preview with President & CEO James Chappell
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 226: Orlando Health’s Expansions and Research with Amy Allen and Thibaut Van Marke of Orlando Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 225: Cancer Care Access & Treatments with Dr. Sengar of Alabama Cancer Care
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Wolf Greenfield’s New Shareholders
This is the third post in a 3-part series. Below, we describe Example 49 which focuses on using AI to assist with a medical treatment....more
In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more
As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs. In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
In October of 2023, a hacker claimed online that they had 23andMe users’ profile information. We know this as a result of 23andMe’s required statement to the U.S. Securities and Exchange Commission (SEC) on December 1, 2023. ...more
Are Automakers Making Sufficient Efforts to Protect Customer Data? With the ever-expanding Internet of Things, data privacy is a growing concern in today’s digital age. The automotive industry is no exception. The National...more
Remarkable progress in DNA and RNA sequencing have democratized the generation and analysis of genomic data across diverse industry sectors, including biopharmaceutical research, healthcare, consumer ancestry, law...more
This is Part Ten in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”), where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more
This is Part Nine in a series of legal updates on the Washington My Health My Data (“WMHMDA”) where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more
This is Part Seven in a series of legal updates on the Washington My Health My Data (“WMHMDA”), where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more
In the FTC’s first case focused on the privacy and security of genetic information, the FTC alleges that San Francisco-based Vitagene, Inc. – now known as 1Health.io – failed to live up to its promises and unfairly changed...more
This is Part Two in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”) where Quarles is doing a deep dive into the various factors and intricacies of the Act that are shaping up to create a sea of...more
The Federal Trade Commission (FTC) continues to prioritize the protection of consumers’ digital health information. The agency has demonstrated this commitment through enforcement actions against GoodRx and BetterHelp for...more
Amazon Sued for Not Telling New York Store Customers about Tracking Biometrics - “Thanks to a 2021 law, New York is the only major American city to require businesses to post signs letting customers know they’re tracking...more
In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more
On July 1, 2019, the Administrative Regulations on Human Genetic Resources (人类遗传资源管理条例) (the “Regulations”) issued by the State Council of the People’s Republic of China (the “PRC”) came into effect. On October 17, 2020, the...more
Last month, California Governor Gavin Newsom signed Senate Bill 41, the Genetic Information Privacy Act (“GIPA”), a law that regulates “direct-to-consumer genetic testing companies” that handle the “genetic data” of...more
The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more
Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more
In Washington: The White House Coronavirus Task Force is warning that there may be a new fast-spreading U.S.A. variant of the coronavirus. "This fall/winter surge has been at nearly twice the rate of rise of cases as the...more
The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid...more
On September 28, California Governor Gavin Newsom signed AB-713 into law, which relaxes some of the California Consumer Privacy Act (CCPA) compliance challenges faced by the health care and life science industries — more...more
On August 31, 2020, the California legislature passed California AB 713, which amends the California Consumer Privacy Act (CCPA) to except from its requirements certain health information, including information that has been...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
On January 1, 2020 California Consumer Privacy Act (“CCPA”) largely came into effect, albeit with several last-minute modifications and a need to promulgate regulations. ...more