Digital Health & Technology
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February 07, 2024
Surgical Robot Co. Sued Over Internal Burns, Death Of Patient
A widower is suing Intuitive Surgical Inc. in Florida federal court, alleging the company hid a defect in its da Vinci surgical robots that allowed electricity to arc during his wife's surgery, burning her small intestine and leading to her death.
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February 06, 2024
HHS Signs $4.75M Pact With NYC Hospital Over Data Theft
A hospital in New York City's borough of the Bronx has agreed to pay $4.75 million and implement a corrective active plan to resolve the U.S. Department of Health and Human Services' claims that Montefiore Medical Center's "multiple" potential data security failings led to an employee stealing and selling thousands of patients' protected health information, the HHS said Tuesday.
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February 06, 2024
10th Circ. Affirms $4.7M Stryker Loss, But Tosses Fee Award
A Tenth Circuit panel said on Tuesday that medical device maker Stryker is not required to indemnify a Colorado distributor for the cost of winning a lawsuit against it, according to a ruling that upheld a $4.7 million judgment against Stryker but vacated a $2.3 million fee award.
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February 06, 2024
Medical Device Co. Accuses Ex-Sales Reps Of Stealing Clients
Two sales representatives broke noncompete and confidentiality agreements when they "conspired to steal" more than $1 million worth of business from their then-employer before leaving for a competitor, a medical device company alleged in a suit filed Monday in Texas federal court.
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February 06, 2024
Attys Seek $750K Fee In Del. For $6M Med Tech Co. Deal
Proposed class attorneys who secured a $6 million settlement from medical device company AMDI Inc. after a purportedly underpriced and conflicted stock sale to an interest of Oracle founder Larry Ellison have asked Delaware's Chancery Court to approve $750,000 in attorney fees for their work.
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February 06, 2024
AI Operating System Built For Healthcare Lands $70M
San Francisco-based Ambience Healthcare, a generative AI technology startup targeting the medical world, has raised $70 million in Series B funding, the company announced Tuesday.
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February 05, 2024
Kochava Can't Shake FTC's Location Data Privacy Suit
An Idaho federal judge has refused to ax the Federal Trade Commission's suit accusing mobile app analytics provider Kochava Inc. of unlawfully selling precise geolocation data, finding that the expanded consumer harm allegations that the agency put forth in its revised complaint were sufficient to allow the dispute to move forward.
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February 05, 2024
Colo. Software Co. Won't Release Patient Data, Practice Says
A Connecticut-based fertility practice has alleged in Colorado state court that a Denver software vendor has held its patients' records hostage since the two companies mutually agreed to end their business relationship nearly a year ago.
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February 02, 2024
ACLU Atty On How To Protect Civil Liberties In The AI Era
Because artificial intelligence and algorithmic systems often operate in the shadows, there's a new need for legislation, regulation and enforcement to ensure the technology doesn't undercut civil liberties by engaging in discrimination in housing, education or employment, according to Cody Venzke, senior policy counsel for the American Civil Liberties Union.
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February 02, 2024
Ascension Says Medical Queries Don't Breach Genetic Privacy
Questions about family medical history raised during a hospital job interview don't implicate an Illinois genetic privacy law, healthcare giant Ascension Health has told a Missouri federal court.
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February 02, 2024
Groups Urge Probe Into Deloitte's Medicaid Eligibility System
A group of public interest organizations is accusing Deloitte of developing a problematic Medicaid eligibility system that's left beneficiaries in Texas without healthcare coverage, and has asked the Federal Trade Commission to investigate.
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February 01, 2024
DOJ Looking For Privacy Perils In Digital Healthcare
Threats to data privacy and fraud in telemedicine are among federal regulators' top concerns in evaluations of digital healthcare as innovation invites new challenges to protecting patient data and preventing fraud, a U.S. Department of Justice official said Thursday.
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February 01, 2024
Device-Maker Attys Talk FDA Nondevice Rule At Conference
Over a year after the FDA issued its Clinical Decision Support Software guidance for nonmedical devices that describes the agency's approach to medical device software functions, attorneys working in the medical device regulation space are still grappling with the guidance and learning how the FDA is enforcing the regulation.
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February 01, 2024
FTC Puts Cap On Blackbaud's Data Retention In Breach Deal
Blackbaud Inc. has agreed to delete personal data that it doesn't need anymore and boost its data security to resolve the Federal Trade Commission's claims over a 2020 ransomware attack that affected millions of consumers, the commission announced Thursday, marking the latest regulatory action the software provider has settled over the data breach.
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February 01, 2024
Drug Cos. Not Ready for 'Deep End' of Remote Trials
Enthusiasm among drug companies and federal officials about increasing diversity among clinical subjects through "decentralized" trials is being tempered by unknowns about the regulatory landscape, a group of experts said Thursday.
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February 01, 2024
HHS OKs Telehealth, At-Home Flexibility For Opioid Treatment
Federal authorities plan to permanently extend pandemic-era rules that allow patients in opioid treatment programs to take methadone at home and obtain prescriptions for buprenorphine during telehealth visits, as part of an effort to combat opioid addiction.
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January 31, 2024
FDA Has More Cyber Guidance Planned For Device Makers
A U.S. Food and Drug Administration official said Wednesday that further guidance is likely in store in 2024 as the agency marks its first year with the new authority to require device makers to submit cybersecurity compliance plans with applications to bring new healthcare devices to market.
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January 31, 2024
FDA May Have To Cut Activities As Need to Regulate AI Grows
The U.S. Food and Drug Administration may have to pare back functions if Congress doesn't grant it the budget increase it has requested while the agency tries to keep up with rapid developments in the use of artificial intelligence in healthcare.
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January 31, 2024
FDA, Health Experts Talk Int'l 'Harmonization' of AI Regulation
Cross-border compatibility of rules for artificial intelligence-powered medical devices is critical for device makers looking to globalize their products in an evolving regulatory landscape, legal and governmental experts said Wednesday.
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January 31, 2024
Northwell Health Sued Over Breach Of 3M Patients' Data
Northwell Health Inc., New York state's largest health care system, breached its duty to protect sensitive information by failing to keep safe the data of over 3 million individuals in a breach, according to a proposed class action filed Tuesday.
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January 31, 2024
Teladoc Illegally Sends Users' Personal Info To Meta, Suit Says
Teladoc users have filed a putative class action in New York federal court accusing the virtual healthcare giant of privacy invasion for allegedly using a tracking pixel on its website to secretly wiretap their communications and activities, then subsequently sharing their personal information with Facebook without their permission.
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January 31, 2024
Lab Says $7M Stolen Data Is Property And Should Be Covered
A national medical testing lab told a Pennsylvania federal court that patient treatment records and at least $7 million of billing data allegedly hijacked by its software contractor was property and should therefore be covered by its insurer.
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January 31, 2024
Fla. Man Avoids Jail In Telemedicine Fraud Suit
A Florida resident did not receive prison time during a federal court hearing Wednesday and instead was sentenced to a period of supervised release for his role in a company that prosecutors say was built to scam insurers into paying millions of dollars for prescriptions that patients didn't need.
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January 30, 2024
CareFirst Judge Mulls Class OK In Trimmed Data Breach Row
A D.C. federal judge on Tuesday appeared open to the possibility of certifying a class of CareFirst policyholders that would seek only nominal damages against the health insurer for a 2014 data breach that exposed personal information belonging to roughly 1.1 million customers.
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January 30, 2024
NC Hospital Says It Didn't Share Patient Data With Meta
A North Carolina hospital system scoffed at allegations that it shared patient information with Facebook without consent for years in response to a proposed negligence class action brought by three patients and after a state business court allowed the action to move forward.
Expert Analysis
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A Law Of The Digital Sea Could Expand Data Rights, Oversight
Democracies should implement a law of the digital sea that can balance innovation with individual rights and national security by mandating personal ownership of data, rigorously enforcing antitrust law, and empowering agencies like the Consumer Financial Protection Bureau to grade cyberhygiene, says Luke Schleusener at QOMPLX.
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How 2020 Changed Product Liability — And What's Next
Like many other legal sectors, product liability regulation and litigation felt the sharp impact of COVID-19 in 2020, especially in health care and life sciences — and 2021 may hold more pandemic-related changes, as well as a new regulatory approach from the Biden administration, say attorneys at MoFo.
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Gov't Pandemic Response Will Boost Life Sciences In 2021
The U.S. government's response to the COVID-19 pandemic has shown increasing openness to collaborating with life sciences and health companies, leading to advancements in telemedicine and the use of virtual environments that will likely continue through 2021 and beyond, say attorneys at Hogan Lovells.
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FCA Whistleblowers Are More Important Than Ever Before
Though a recent Law360 guest article argued that the new U.S. Department of Health and Human Services' False Claims Act working group is correctly deemphasizing the role of whistleblowers, the group does not actually favor defense counsel and whistleblowers are crucial now due to the surge in emergency funding caused by the pandemic, says attorney Neil Getnick.
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2020 ERISA Litigation Trends Hint At What's Ahead This Year
Trends from a record-setting year for Employee Retirement Income Security Act litigation show no signs of slowing down in 2021, with more excessive fee claims targeting smaller plans, health coverage continuation notice lawsuits, and challenges to defined benefit plans’ actuarial assumptions likely on the horizon, say attorneys at Groom Law.
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2 Major Digital Health Trends Driven By COVID-19
The COVID-19 pandemic and resulting regulatory flexibility have enabled rapid development of information technology and big data in the digital health space that may continue to accelerate in the years ahead, say attorneys at Ropes & Gray.
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How New Kickback Rules Benefit Health Care Industry: Part 2
While the U.S. Department of Health and Human Services' changes to the Anti-Kickback Statute and Stark Law related to value-based health care delivery and payment garnered the most attention from the health care industry, the new rules include a number of other industry-friendly changes, say Karen Lovitch and Rachel Yount at Mintz.
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How COVID-19 Accelerated Telehealth In 2020
Telehealth experienced unprecedented expansion due to COVID-19 in 2020, and its technological, legal and logistical trajectory is poised to continue beyond the pandemic, say attorneys at Marshall Dennehey.
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How New Kickback Rules Benefit Health Care Industry: Part 1
Recently finalized U.S. Department of Health and Human Services rules, implementing changes to the Anti-Kickback Statute and Stark Law, advance the health care industry's transition to value-based care by removing obstacles to innovative cost-sharing arrangements, say Karen Lovitch and Rachel Yount at Mintz.
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COVID-19 Vaccines Unlikely To Create Litigation Opportunities
Although COVID-19 vaccines are on the horizon, litigation opportunities may be limited due to the Public Readiness and Emergency Preparedness Act's significant liability protections for not only vaccine manufacturers, but also virtually all entities in the supply chain, say Eric Kraus and Jennifer Shah at Phillips Lytle.
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Overcoming Immunity Of Foreign Gov't Cyberattack Sponsors
To combat the emerging threat of foreign state-sponsored cyberattacks on U.S. businesses and citizens, litigants need to creatively argue for exceptions to immunity under the Foreign Sovereign Immunities Act for foreign governments, say Jerry Goldman and Bruce Strong at Anderson Kill.
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The State Of Consumer Class Actions Amid COVID-19
While the pandemic has slowed the filing of consumer class actions, they remain a significant part of the litigation landscape — with false labeling claims remaining particularly popular, likely because they are easy to file and frequently survive motions to dismiss, say attorneys at Skadden.
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Anticipating The Biden Administration's Health Care Agenda
The Biden administration is unlikely to successfully push sweeping and partisan health care legislation in the next two years, but it will be able to reverse a litany of Trump administration policies pertaining to the Affordable Care Act, reproductive health care and more, say Nick Manetto and Ilisa Halpern Paul at Faegre Drinker.