Digital Health & Technology
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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.
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January 30, 2024
Stryker Can't Slip California Workers' Wage Suit
Medical device company Stryker cannot escape former workers' wage claims, a California federal judge ruled Tuesday, saying it was unclear whether the company was the workers' employer because it still retained some authority over workers employed by the company's subsidiaries.
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January 29, 2024
Reps Want More From VA On AI Transparency, Enforcement
Members of the House of Representatives on Monday grilled officials from the U.S. Department of Veterans Affairs on how they plan to protect veterans' privacy and ensure transparency in the development and deployment of artificial intelligence models.
Expert Analysis
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What DOJ's 2022 Recovery Stats Say About FCA Enforcement
Despite showing a decline in False Claims Act recoveries in fiscal year 2022, the U.S. Department of Justice's recently released statistics should lead companies to expect a continued rise in government-initiated investigations, pandemic-related fraud enforcement and FCA cases involving new technology, say attorneys at Crowell & Moring.
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Medicare Developments Ahead For Remote Health Monitoring
Stakeholders interested in remote monitoring services should keep an eye on an upcoming multijurisdictional contractor advisory committee meeting that may lead to a new local coverage determination affecting Medicare coverage for remote monitoring devices, say attorneys at McDermott.
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Calif. Privacy Law Holds Implications For Mental Health Apps
California is leading the way in privacy regulation with its amended Confidentiality of Medical Information Act, which has important compliance repercussions for mental health app developers and could serve as a model for similar laws in other states, say Christine Moundas and Elana Bengualid at Ropes & Gray.
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New Clinical Trial Law Promotes Diversity And Modernization
The Food and Drug Omnibus Reform Act, signed into law last month, will likely encourage more equitable subject recruitment and enrollment in clinical trials, and also could create a pathway toward clarifying ambiguities that have historically been left for regulated entities to piece together, say attorneys at Ropes & Gray.
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Evaluating The Legal Ethics Of A ChatGPT-Authored Motion
Aimee Furness and Sam Mallick at Haynes Boone asked ChatGPT to draft a motion to dismiss, and then scrutinized the resulting work product in light of attorneys' ethical and professional responsibility obligations.
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2022 Law And Policy Highlights In Digital Health Care
This year, federal regulators made good on several commitments to create new opportunities for digital health innovators, and a number of promising cybersecurity bills are on the horizon, but not all virtual health care law and policy developments have been positive, say attorneys at Arnold & Porter.
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Next Compliance Steps For Health Cos. Using Tracking Tech
In light of the U.S. Department of Health and Human Services Office for Civil Rights' expansive view of what constitutes protected health information, regulated entities seeking to provide websites and mobile apps for patients may need to choose between several imperfect compliance pathways if they wish to continue using tracking technologies, say attorneys at Ropes & Gray.
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Top Trends And Challenges For Health Care Financing In 2022
Rising inflation, interest hikes, supply chain issues and public market disruption are just some of the factors that made 2022 a challenging year for financing health care deals, and all indications point to continued headwinds next year, say Stephanie McCann and Samantha Koplik at McDermott.
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2022 Data Privacy Suits Tested New Liability Theories
In the absence of a comprehensive federal data privacy law, plaintiffs lawyers are testing new theories of liability under state laws, and a look at recent lawsuits against online companies that have resulted in large settlements shows these attempts are more frequently being met with success, say attorneys at Quinn Emanuel.
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How EU's New Pharma Incentives May Affect US Cos.
Geneviève Michaux and Georgios Symeonidis at King & Spalding examine Europe's recent revisions to its General Pharmaceutical Legislation and the Orphan and Paediatric Legislation, and consider the European Commission's related policy proposals, with an emphasis on pharmaceutical incentives and impacts for U.S. pharmaceutical developers and manufacturers that market products in Europe.
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HHS Bulletin Raises HIPAA Risks For Online Tracking Vendors
A new bulletin from the U.S. Department of Health and Human Services clarifies how the Health Insurance Portability and Accountability Act applies to information collected by tracking technology on websites and mobile apps, creating new compliance considerations for online tracking vendors that may be unfamiliar with HIPAA, says Mason Fitch at Hintze Law.
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Compliance Considerations For Virtual Ketamine Clinics
In the wake of investigations into several online prescribers of controlled substances, it is more important than ever that virtual clinics providing off-label ketamine treatment for mental and behavioral health issues consider five key aspects to staying compliant with medical practice and controlled substance regulations, say attorneys at Goodwin.
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State Regulation Compliance Tips For Telehealth Employers
Nondisclosure, onboarding and reimbursement challenges are behind many remote work-related telehealth employment lawsuits, but with advance planning and knowledge of the state's requirements where practitioners are located, telehealth employers can avoid costly mistakes from the inception through the end of employment, say attorneys at Foley & Lardner.