Digital Health & Technology
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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.
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January 17, 2024
Apple Drops Blood Oxygen Tech From New Watches After Ban
After the Federal Circuit ruled Wednesday that Apple can't import Apple Watches that include a blood oxygen sensor found to infringe two Masimo patents, Apple said the feature will be dropped from its flagship watch models sold beginning Thursday.
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January 16, 2024
Hospital Groups Nationwide Slam Online Tracking Restrictions
Federal guidance restricting the use of online tracking technology in healthcare has disrupted the ability of hospitals to reach underserved communities and connect the public with accurate medical information, 17 state hospital associations told a federal court.
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January 16, 2024
Crowell Adds Moses Singer Health Trio In New NYC Office
Crowell & Moring LLP announced Tuesday that it has hired a team from Moses & Singer LLP with rare expertise in regulatory and compliance issues related to clinical trials for biotech and health tech companies.
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January 15, 2024
Apple Cleared To Avoid Import Ban With Redesigned Watch
U.S. Customs and Border Protection has found that redesigned versions of the Apple Watch without a blood oxygen monitor are not subject to an import ban in a patent dispute with Masimo, according to a Monday court filing by Masimo.
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January 12, 2024
Healthcare Co. HealthEC Hit With Data Breach Suit
Healthcare software company HealthEC has been hit with a lawsuit alleging that a July 2023 data breach affected nearly 4.5 million patients and that the company failed to comply with Federal Trade Commission guidelines and industry standards.
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January 12, 2024
Lab Says COVID-19 Test-Maker Owes $30M Over Faulty Kits
A California-based manufacturer of COVID-19 testing kits has been hit with a $30 million suit alleging it sent defective tests to an independent clinical lab, causing the lab to receive false positive results and subsequently get banned from testing sites.
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January 11, 2024
Quest Fertility Biz Reaches $1.25M Deal In Data Breach Case
A Quest Diagnostics fertility treatment unit has reached a $1.25 million settlement, according to a Wednesday filing in Massachusetts federal court, after a 2021 ransomware attack and accusations that a slow response by Quest left sensitive information unguarded.
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January 11, 2024
Electronic Waveform Says Travelers Owes It $1.3M
A Minnesota medical device manufacturer has told a federal court that insurer Travelers has been intentionally down-coding a pain management device popular among professional athletes in order to underpay the company, resulting in a loss of $1.3 million.
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January 11, 2024
FCC Issues Final Rule On Rural Telehealth Discount
The Federal Communications Commission on Wednesday issued an update to the Rural Health Care program, changing it to allow healthcare providers with conditional eligibility to request funding and compete for bidding.
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January 11, 2024
Conn. Healthcare Co. Eyes Deal For Data Breach Class
Merritt Healthcare Advisors is working to finalize a settlement with a proposed class of consumers who claim that the company's lax security allowed cybercriminals to access their personal information, according to a paperless order entered Thursday in the District of Connecticut.
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January 10, 2024
Rex Medical Asks Fed. Circ. To Decry Slashing Of $10M Award
Rex Medical LP is asserting to the Federal Circuit that a Delaware federal judge was wrong to slash a jury's $10 million patent damages verdict in Rex's favor to just $1 over a purported lack of evidence.
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January 10, 2024
FDA 'Can't Do This Alone,' Wants Help Vetting AI In Healthcare
The Food and Drug Administration will almost certainly need outside help regulating the safety of artificial intelligence deployed by hospitals and healthcare organizations, the agency's commissioner said Wednesday, citing the complexity of the technology and need to track health outcomes over long periods of time.
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January 09, 2024
FDA Digital Tech Rule Faces Health Privacy, Inequity Test
A new federal road map for collecting "remote" health data in clinical investigations could help speed such technologies to the marketplace, experts told Law360, while creating new risks to patient privacy and the effort to address inequities in healthcare.
Expert Analysis
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Navigating Risks In FDA's New Digital Health Tech Guidance
The U.S. Food and Drug Administration’s recent guidance highlights several key benefits and risks regarding the use of digital health technologies to collect data in remote clinical trials, so practitioners will need to address the legal ramifications, including potential liability and data privacy concerns, says Janice Sperow at Sperow ADR.
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Anti-Kickback Safe Harbors May Be Less Safe After Medtronic
A California federal court's recent order denying dismissal in U.S. v. Medtronic improperly acknowledges intent as a liability factor in a suit alleging violations of the Anti-Kickback Statute, which is likely to erode certainty in statutory AKS safe harbor protections, says Scott Landau at Abell Eskew.
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How Health Care Cos. Can Prepare For DOJ's Cyberfraud Push
Enforcement of the U.S. Department of Justice’s new cyberfraud initiative will initially occur largely through civil investigations that broadly apply the False Claims Act, so health care organizations should ensure that their practices can withstand hacks, whistleblowers and government scrutiny, say Katie McDermott and Mark Krotoski at Morgan Lewis.
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How Investors Can Navigate A Vibrant Digital Health Market
With investment activity surging across the digital health care industry, investors must balance their interest in transformative technologies with the inherent risks of platforms and models that have yet to be fully proven, says Brian Gordon at McDermott.
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What Cos. Can Learn From The 2021 FCA Recovery Statistics
Attorneys at Winston unpack the recently released U.S. Department of Justice False Claims Act recovery statistics for fiscal year 2021, discuss how they compare to prior years and what companies in an expanding array of industries should expect next.
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Expect Aggressive Life Sciences Enforcement In 2022
This year, life sciences companies should prepare for heightened activity from the U.S. Department of Justice and U.S. Food and Drug Administration, which will likely target illicit opioid distribution, clinical trial fraud and other key areas, say attorneys at Ropes & Gray.
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The Rising Demand For Commercial Litigators In 2022
Amid broken supply chains, pandemic-induced bankruptcies and a rise in regulation by litigation, strong commercial litigators — strategists who are adept in trying a range of tortious and contractual disputes — are becoming a must-have for many law firms, making this year an opportune moment to make the career switch, say Michael Ascher and Kimberly Donlon at Major Lindsey.
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Health Care Policy Priorities To Watch In 2022
The Build Back Better Act is at the forefront of Congress' lengthy health care agenda this year, but there are a number of other issues that health companies and their legal teams should watch closely, including the pandemic's continuing impact on telehealth licensure requirements, surprise-billing regulations and increasing scrutiny of market consolidation, say Miranda Franco and Robert Bradner at Holland & Knight.
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The State Of FDA Regulation Of Software As A Medical Device
Though the U.S. Food and Drug Administration has accelerated activities related to software as a medical device, developers should carefully consider guidance gaps and challenges regarding transparency and change management in software that utilizes artificial intelligence and machine learning, says Nicholas Diamond at C&M International.
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What DOJ's Cyberfraud Initiative Means For Health Cos.
Though the U.S. Department of Justice's new cyberfraud initiative does not single out the health care industry, health and life sciences companies may be subject to heightened scrutiny under the False Claims Act and should prepare accordingly, say attorneys at Ropes & Gray.
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How Medical Device Cos. Can Limit Enforcement, Legal Risks
With recent cases highlighting the myriad consequences that compliance failures can bring to medical device manufacturers, it is imperative that companies take proactive steps to avoid U.S. Food and Drug Administration enforcement and pay particular attention to keeping warning letters out of evidence in product liability suits, say attorneys at Phillips Lytle and Compliance Team.
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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.