Digital Health & Technology
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January 29, 2024
FDA Seeks Input On Reporting Race, Ethnicity In Drug Trials
The Food and Drug Administration asked the healthcare industry Monday for comment on updated guidance that outlines the agency's expectations for collecting race and ethnicity data in drug and medical device research.
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January 29, 2024
Imperative Care Names O'Melveny Deals Partner As CLO
Silicon Valley's Imperative Care announced Monday that an O'Melveny deals partner will take over as chief legal officer, joining a revamped leadership team at the medical tech company.
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January 26, 2024
23andMe Users Say Hackers Targeted Jewish, Chinese Data
Hackers who pushed their way past 23andMe's security systems in a data breach last year were after the personal information of Jewish and Chinese customers, but the biotechnology company hid that detail when notifying 7 million affected customers, according to a proposed class action filed Friday in California federal court.
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January 26, 2024
Bills Aim To Halt Cash To Chinese Cos. Over Genetic Data
Lawmakers on Capitol Hill have introduced legislation to block Chinese biotech companies from receiving federal funding if they have ties to the Chinese Communist Party, saying the goal is to prevent such companies and the party from stealing America's genetic data.
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January 26, 2024
Ex-Goodwin Procter Life Sciences Atty Joins DLA Piper In NY
DLA Piper announced it has hired an experienced life sciences transactional attorney from Goodwin Procter LLP as a New York-based partner in its corporate practice.
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January 25, 2024
Morgan & Morgan Beats Firms To Lead Zoll Data Breach Row
A Massachusetts federal judge on Thursday tapped Morgan & Morgan PA to lead a proposed class action by customers of Zoll Medical Corp. alleging the company failed to protect their private information in two data breaches, rejecting a competing bid by Hausfeld LLP and DiCello Levitt.
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January 24, 2024
Med Device Employee Gets 1 Year For Forging FDA Clearance
A former worker for a medical device maker was sentenced Wednesday to a year in prison after pleading guilty to his role in selling medical equipment that did not have governmental approval.
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January 24, 2024
Software Co. Says Data Breach Victims Aren't Customers
NextGen Healthcare is asking a Georgia federal court to dismiss a proposed consolidated class action because the plaintiffs don't have a relationship with the software company that would make it liable for damages, even as it acknowledged their health information was compromised by a cyberattack.
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January 23, 2024
Australia, US, UK Sanction Russian Over Medibank Hack
Officials from Australia, the U.S. and the United Kingdom revealed Tuesday that they had sanctioned a Russian national believed to have played an integral role in a 2022 cyberattack that hit Australian health insurer Medibank Private Ltd., marking the first time the three nations have made such a coordinated strike.
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January 23, 2024
FDA Pilot Program Accepts First AI Health Technology
An automated depression and anxiety severity measurement tool is the first artificial intelligence-based and digital health technology-based project as well as the first neuroscience project accepted into the U.S. Food and Drug Administration's Innovative Science and Technology Approaches for New Drugs Pilot Program, or ISTAND, the agency announced Tuesday.
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January 22, 2024
NY Senate Backs Bill Bolstering Healthcare Data Privacy
New York state's Senate on Monday signed off on legislation that would require companies collecting and selling healthcare information to have user consent before selling that data to third parties, passing a bill that's part of a legislative package lawmakers say is aimed at "reproductive equity."
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January 22, 2024
Anna Jaques Hospital Sued In Mass. Over Hacked Patient Data
Anna Jaques Hospital was hit with a proposed class action on Monday in Massachusetts state court alleging the hospital failed to maintain adequate cybersecurity measures, leading to a December breach potentially involving thousands of patient records.
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January 22, 2024
4th Circ. Preview: Timberland's TM Bid Kicks Off 2024
The Fourth Circuit will kick off 2024 by probing Timberland's bid to trademark its footwear and pondering an embattled insurance mogul's attempt to escape a $524 million judgment.
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January 22, 2024
Boston Biopharma Co. Picks Industry Veteran As Next GC
Biopharma company BPGbio Inc. announced Monday the appointment of a compliance specialist and former Cooley LLP associate as its new general counsel.
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January 19, 2024
Law360 Names Firms Of The Year
Eight law firms have earned spots as Law360's Firms of the Year, with 55 Practice Group of the Year awards among them, steering some of the largest deals of 2023 and securing high-profile litigation wins, including at the U.S. Supreme Court.
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January 19, 2024
Law360 Names Practice Groups Of The Year
Law360 would like to congratulate the winners of its Practice Groups of the Year awards for 2023, which honor the attorney teams behind litigation wins and major deals that resonated throughout the legal industry this past year.
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January 19, 2024
Lawmakers Urge HHS To Make Telehealth Policy Permanent
A bipartisan group of senators and representatives on Friday pressed the U.S. Department of Health and Human Services to make permanent the temporary pandemic-era expansions in Medicare telehealth coverage before the end of the year.
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January 19, 2024
Colo. Group Seeks Damage Caps Drop, Reporting Expansion
An issue committee, supported in part by the Colorado Trial Lawyers Association, has launched an effort to place two statewide initiatives before Colorado voters in November, designed to help patients and those filing suits over catastrophic injuries and wrongful deaths.
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January 19, 2024
Becton Investors Get Initial OK Of $85M Deal Over Recall
A magistrate judge granted preliminary approval to an $85 million settlement a class of Becton Dickinson investors reached with the medical tech company over securities fraud claims that it hid regulatory problems regarding sales of its Alaris infusion pump, which Becton recalled in 2020.
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January 19, 2024
WHO Report Examines Pros And Cons Of AI In Healthcare
The World Health Organization has released new guidance on opportunities and ethical risks presented by introducing generative artificial intelligence models such as ChatGPT into the healthcare sector.
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January 19, 2024
Fla. Medical Device Co. Sued Over Data Breach That Hit 54,000
A Tampa-based medical device company has been sued over a data breach that allegedly compromised the personal information of 54,000 people, with a proposed federal class action alleging that the company was negligent in protecting its customers' private data.
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January 18, 2024
FTC Asked To Force Google To Delete Sensitive Location Data
Google hasn't kept its promise to delete sensitive location data, including records of users' visits to abortion clinics and addiction centers, a pair of tech advocacy groups told the Federal Trade Commission on Thursday, urging the commission to hit Google with penalties and block its "unlawful" data practices.
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January 18, 2024
CMS Announces State-Based Behavioral Health Model
The Centers for Medicare & Medicaid Services on Thursday launched a program it said will fund up to eight states to implement a new value-based care model designed to improve health outcomes for vulnerable populations.
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January 18, 2024
FDA And CMS Leaders Unite Over Proposed Lab Test Rule
Leaders at the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services joined forces on Thursday, stressing that the two agencies are on the same page regarding the FDA providing increased oversight of laboratory developed tests, or LDTs.
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January 18, 2024
Midwest Healthcare Group Escapes Bulk Of Data Breach Suit
An Illinois federal judge tossed most of a proposed class action alleging an anti-poverty nonprofit's careless management of clients' personal information, including sensitive health information, resulted in a data breach.
Expert Analysis
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How Growing Cyber Scrutiny Affects Corporate Compliance
In the face of overlapping cybersecurity initiatives at the U.S. Departments of Justice and Health and Human Services, health care companies and government contractors should prepare for microscopic scrutiny by ensuring specific components are included in compliance programs and being mindful of reporting obligations under existing corporate integrity agreements, say attorneys at Verrill Dana.
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Choosing The Right IP Protections For Telehealth Innovations
Telemedicine and digital health innovations are likely to stay after the COVID-19 pandemic ends, so inventing companies must decide on a comprehensive intellectual property strategy, considering the goals, risks and upfront requirements offered by both patent and trade secret protections, say Eric Sophir and Matthew Horton at Foley & Lardner.
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A Phased Approach To In-House Legal Tech Adoption
In-house legal departments that adopt new technologies too quickly often face frustration or failure, so to help ensure a smooth transition, companies should consider a multistep approach, depending on where they stand with respect to modernizing legal processes, says Tariq Hafeez at LegalEase Solutions.
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3 Practice Tips For Patenting Medical Devices In A Digital Age
In light of a recent surge in digital therapeutic applications that help manage or treat diseases, there are several best practices to follow when patenting medical devices and software, including improving upon existing technology and making the claims as specific as possible, say attorneys at Crowell & Moring.
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How To Minimize FCA Cyber Fraud Enforcement Risk
As the U.S. Department of Justice’s new Civil Cyber-Fraud Initiative signals a rise in False Claims Act enforcement and whistleblower actions for cybersecurity-related fraud, government contractors and grantees should take five preventative steps to mitigate increased risks, say Brenna Jenny and Sujit Raman at Sidley.
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What Blockchain Means For The Future Of US Health Care
As the U.S. plays catchup with other countries that have introduced blockchain into their health care systems, the technology is poised to drastically change the industry's revenue cycles, data management and beyond, which will result in better care for patients and more assurance for provider reimbursements, say Michael Ruggio and Jacob Butz at Ice Miller.
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How To Navigate California's New Intrastate CBD Route
Businesses and consumers should prepare for rigorous compliance checks on manufacture, distribution and retail sale of consumer products made with CBD and other hemp-derived cannabinoids. following California's new law opening the potentially enormous market for these items, says Christian Foote at Clark Hill.
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Manufacturers Face Evolving COVID-19 Legal Challenges
Product manufacturers must adopt new strategies to defend against pandemic-related legal challenges, including discovery delays in health care litigation, novel consumer protection claims, aggressive government enforcement actions and supply chain disputes, says Stephanie Laws at Maslon.
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FTC's Hasty Health Data Rule Change Could Cause Confusion
The Federal Trade Commission's recent policy statement expanding the scope of its Health Breach Notification Rule appears to bypass appropriate administrative processes and may delay effective privacy and security policies that can advance interoperability and health innovation, says Jodi Daniel at Crowell & Moring.
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'McMorris Factors' Create Obstacles For Data Breach Plaintiffs
The factors for evaluating standing in the context of data breach allegations set forth by the Second Circuit in McMorris v. Carlos Lopez & Associates earlier this year may be difficult, if not impossible, for plaintiffs to satisfy, but the standard varies from circuit to circuit, say David Topol and Pamela Signorello at Wiley.
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Telehealth Providers Must Beware Of Fraud As Industry Grows
A recent fraud charge against a telehealth executive highlights the rise we're seeing in telefraud scams during the industry's pandemic growth, and there are some steps that all health providers should take to stay clear of potentially illegal arrangements, says LaTawnda Moore at Dinsmore.
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The Regulatory Growing Pains For Digital Health Companies
The meteoric rise of digital health services during the pandemic has been matched with increasing regulatory scrutiny in the U.S. and abroad, resulting in a patchwork of laws and approaches that could leave a damper on the industry's growth, say attorneys at Kobre & Kim.
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Policyholder Best Practices As Cyberattacks Escalate
As ransomware attacks increasingly target corporate victims, policyholders should enhance cybersecurity and privacy efforts to avoid regulatory hot water and mitigate the effects of rising insurance premiums and coverage restrictions, say Lee Epstein and Krishna Jani at Flaster Greenberg.