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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Where Data Privacy And CFPB Are Headed Under Biden
Data privacy is likely to be a key area of legislative and enforcement focus for President-elect Joe Biden, and consumer financial protection is expected to be an immediate priority due to the economic impact of the pandemic, with the most drastic shift likely to occur at the Consumer Financial Protection Bureau, say attorneys at Gibson Dunn.
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Ethics Considerations For Law Firms Implementing AI
Richard Finkelman and Yihua Astle at Berkeley Research Group discuss the ethical and bias concerns law firms must address when implementing artificial intelligence-powered applications for recruiting, conflict identification and client counseling.
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The Legal Implications Of Mobile Health Advancements
With the pandemic rapidly accelerating the timeline for the shift to remote and mobile health care, providers will need to keep a close eye on new privacy and cybersecurity risks, and on new potential to collect real-time information from patients, say attorneys at Squire Patton.
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The Post-Election State AG Enforcement Landscape
Election results so far have kept the number of Republican and Democratic state attorneys general even, and no matter the outcome of the presidential race, AGs will work across the aisle on important issues like health care, competition and the environment, says former Illinois attorney general Lisa Madigan at Kirkland.
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What A Trump Or Biden Win Will Mean For State AGs
The outcome of the presidential election will have significant consequences on cooperation between federal agencies and state attorneys general, but either way robust multistate investigations — especially in the consumer protection space — will continue, says Sean Riley at Cozen O'Connor.
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Outside Whistleblowers Are Critical To Exposing Fraud
Outsiders like industry experts, competitors, public interest organizations and concerned citizens often have deep knowledge, industry data and financial incentives that put them in a better position than insiders to spot fraud, say attorneys at Youman & Caputo, Fox Rothschild, Goldstein & Russell and Herrera Purdy.
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Comparing Recent State Data Breach Law Updates
Public and private entities should revisit their incident response plans to ensure compliance with and understand the differences among heightened data breach notification requirements that five states and Washington, D.C., added or amended this year, says Jane Petoskey at Polsinelli.
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Best Practices For Health Care Mergers In The COVID-19 Era
Health providers considering consolidation as a result of the pandemic's impact should attempt to mitigate antitrust enforcers' concerns by substantiating a merger with evidence of cost and quality efficiencies and making efforts to seek competition-friendly alternatives, say attorneys at Shook Hardy.
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Assessing Health Data Privacy Damages During A Pandemic
Class action litigation related to data privacy in the health care industry is expected to trend upward during the COVID-19 era due to increased reliance on telehealth and contact tracing initiatives, heightening the importance of understanding the different economic approaches and challenges to valuing damages, say analysts at Cornerstone Research.
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HHS Lab Test Rule's Likely Impact During And After COVID-19
The U.S. Department of Health and Human Services' recent announcement rescinding the U.S. Food and Drug Administration's premarket review requirement for laboratory-developed tests upends regulatory expectations for the clinical laboratory industry and raises questions regarding implementation during the pandemic and beyond, say attorneys at Ropes & Gray.
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Compliance Lessons From $1M HHS Fine For Data Breach
The U.S. Department of Health and Human Services recently fined Lifespan Health over $1 million for Health Insurance Portability and Accountability Act breaches, showing that health care companies should take protective compliance measures, such as encrypting devices and utilizing business associate agreements, say attorneys at Spencer Fane.
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Analyzing Upward And Downward Trends In Legal Tech
Advances in legal technology are often accompanied by bombastic overstatements, but it is important to separate the wheat from the chaff by looking at where various technologies stand on the hype curve, says Lance Eliot at Stanford Law School.
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Telehealth Providers Should Beware ADA Litigation
Health providers making the transition to remote care should furnish communication aid and necessary accommodation for individuals with disabilities, or else plaintiffs may assert claims under the Americans with Disabilities Act, say Frank Morris and Shira Blank at Epstein Becker.