Digital Health & Technology
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May 31, 2024
Samsung Strikes First With Smart Ring IP Suit Against Oura
Samsung has yet to announce a release date for its new Galaxy Ring brand of wearable, health-tracking devices, but it has filed an intellectual property suit in California federal court Thursday targeting a Finnish startup that makes its own line of smart rings.
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May 30, 2024
FTC, SEC Urged To Probe UnitedHealth's 'Negligent' Security
The chair of the U.S. Senate finance committee on Thursday pressed the Federal Trade Commission and the U.S. Securities and Exchange Commission to hold UnitedHealth Group and its top executives liable for "numerous" cybersecurity failings that fueled a debilitating cyberattack on its Change Healthcare unit.
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May 30, 2024
Veradigm Execs Sued Over Company's Nasdaq Delisting
Current and former members of healthcare technology company Veradigm Inc.'s top brass were sued in Illinois federal court by shareholders alleging that the company suffered stock drops following a string of financial reporting blunders starting in 2021, which caused it to overstate roughly $40 million in revenue before facing a delisting notice from Nasdaq.
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May 29, 2024
Greenberg Traurig Adds IP Atty From Eversheds Sutherland
Greenberg Traurig LLP has bolstered its California bench of attorneys with an Eversheds Sutherland lawyer who has years of experience advising digital health and medical device companies on intellectual property issues.
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May 28, 2024
Pharmacy Benefits Co. Taps Health Atty To Lead Legal Team
RxBenefits, a company focused on generating savings for employers providing pharmacy benefits, has appointed a new chief legal officer to oversee its legal and regulatory compliance efforts.
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May 24, 2024
Fla. Lab Owner Will Pay $27M To End False Billing Suit
A Florida medical lab owner who pled guilty to charges related to accusations he billed Medicare for $53 million in unnecessary genetic cancer screening tests has agreed to pay more than $27 million to resolve three whistleblower suits over the same conduct, according to an announcement Friday from the U.S. Department of Justice.
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May 23, 2024
Stryker Unit And Seyfarth Attys Hit With $275K Sanctions
A Colorado federal judge has imposed $275,000 in sanctions jointly and severally on Stryker-owned Howmedica Osteonics Corp., along with Seyfarth Shaw LLP, for witness coaching and discovery violations in a bitter breach-of-contract dispute, amounting to roughly one-eighth of what plaintiff ORP Surgical LLC had sought.
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May 22, 2024
Stryker Agrees To Settle Calif. Misclassification Suit
Medical device company Stryker told a California federal court Wednesday it has agreed to settle a proposed class action accusing it of misclassifying workers as overtime-exempt and failing to pay them overtime during their mandatory training.
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May 22, 2024
Lead Blood Test Maker To Plead Guilty, Pay $42M Over Defects
Medical device maker Magellan Diagnostics has agreed to pay at least $42 million and plead guilty to hiding a defect in its blood testing devices for lead that caused inaccurately low results for tens of thousands of children and others, Massachusetts federal prosecutors said.
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May 21, 2024
Amid Abortion Suit, Ind. Officials Spar Over Report Releases
Indiana's top lawyer is set to respond to a lawsuit seeking access to doctor-created abortion reports. The case promises to highlight a rift between the state's vocally anti-abortion attorney general and other officials who say the information is off-limits to public records requests.
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May 21, 2024
Strategic Hiring Was The New Normal For BigLaw In 2023
The 400 largest law firms by headcount in the U.S. grew more slowly in 2023 than in the previous two years, while Kirkland & Ellis LLP surpassed the 3,000-attorney threshold, according to the latest Law360 ranking.
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May 21, 2024
The Law360 400: Tracking The Largest US Law Firms
The legal market expanded more tentatively in 2023 than in previous years amid a slowdown in demand for legal services, especially in transactions, an area that has been sluggish but is expected to quicken in the near future.
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May 17, 2024
FCA Relators Seek Finders Fee For SpineFrontier Doc Deals
Three whistleblowers who tipped off the federal government to a medical device company's multimillion-dollar kickback scheme said Friday the Justice Department is refusing to pay them a cut of the $3 million in False Claims Act settlements paid by surgeons who admitted participating in the sham consulting ploy.
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May 17, 2024
Ga. OB-GYN Office Says Data Breach Class Action Falls Flat
An Atlanta OB-GYN practice has urged a Georgia federal judge to dismiss a proposed class suit over a data breach that allegedly impacted the personal and protected health information of tens of thousands of patients, arguing the lead plaintiff has failed to meet the requirements of the Class Action Fairness Act.
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May 15, 2024
Blackbaud Dodges Data Breach Victims' Class Cert. Bid
A South Carolina federal judge has refused to certify several proposed classes consisting of roughly 1.5 billion patients, donors and other individuals whose personal information was allegedly swept up in a 2020 ransomware attack on software provider Blackbaud Inc., finding that the plaintiffs had failed to show that class members could be easily identified.
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May 15, 2024
UnitedHealth Concealed DOJ Merger Investigation, Suit Says
UnitedHealth Group has been hit with a proposed shareholder class action alleging that it failed to disclose that the U.S. Department of Justice had reopened an antitrust investigation into the health insurance giant following its acquisition of a healthcare data company, and that top executives had sold more than $120 million of shares knowing about the investigation before a news report revealed it to the public.
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May 14, 2024
Under Fire For Lab Rule, FDA Remains Open To Lawmaking
After a difficult run-up to a new federal rule on lab-developed tests, the U.S. Food and Drug Administration official overseeing medical devices voiced support Tuesday for additional lawmaking.
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May 13, 2024
Wash. Hospital Scores Exit In Facebook Privacy Suit, For Now
A Washington federal judge has tossed a proposed class action accusing a Seattle-area hospital of sharing patients' confidential health information by using Facebook browser tracking tools, ruling on Monday the plaintiff has failed to show that her own private information was input into the website and shared with a third party.
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May 13, 2024
Philips Wants Cleaner Co. To Chip In For $1B CPAP Deal
Koninklijke Philips NV has filed a third-party complaint in Pennsylvania federal court against SoClean Inc., which sells cleaning products for breathing devices, claiming SoClean and its parent should contribute to Philips' $1 billion settlement because its cleaners allegedly exacerbated the foam breakdown at the heart of the litigation.
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May 10, 2024
Retail Group Opposes $1B Arbitral Award Against Walgreens
An advocacy group for the retail industry is backing Walgreens as it looks to set aside a nearly $1 billion arbitral award in a dispute with a COVID test maker, telling a Delaware federal judge that judicial intervention is warranted in this case.
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May 10, 2024
No 'Piecemeal' Fees For Infant Data Win Amid 6th Circ. Appeal
A federal judge said Friday that he wouldn't award attorney fees to children who challenged Michigan's handling of blood samples collected in an infant health screening program until the state's Sixth Circuit appeal is resolved.
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May 08, 2024
Fla. Lab Owner Gets 10 Years For Unneeded Medical Tests
A Florida medical lab owner has been sentenced to 10 years in prison after pleading guilty to charges related to accusations that he billed Medicare for $53 million in unnecessary genetic cancer screening tests.
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May 07, 2024
MultiPlan, Insurance Cos. Accused Of Algorithmic Collusion
A medical provider has lodged a proposed class action in Illinois federal court accusing MultiPlan and major insurance companies, including UnitedHealth, Aetna, Kaiser Permanente and Cigna, of using pricing tools to systematically underpay out-of-network providers.
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May 07, 2024
New FDA Device Rule No Cure For Unregulated Lab Tests
The U.S. Food and Drug Administration's newly claimed authority over lab-developed tests will leave untold numbers of unregulated — and in some cases, inaccurate or otherwise faulty — tests in the hands of clinicians.
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May 06, 2024
Hooper Lundy Adds Government Relations Director
An attorney who worked in-house for healthcare industry trade and advocacy associations has joined healthcare boutique Hooper Lundy & Bookman PC as director of government relations and public policy.
Expert Analysis
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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.
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Navigating Asia-Pacific Health M&A In The Wake Of COVID
Bernard Lui and Vanessa Ng at Morgan Lewis discuss new legal considerations for participants in health care mergers and acquisitions with entities in Singapore and elsewhere throughout the Asia-Pacific region as the pandemic continues.
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Life Sci Cos. Should Prep For Enforcement After COVID Pause
With the U.S. Food and Drug Administration and other federal agencies beginning to turn their sights back to pre-COVID-19 agendas, now is the time for life sciences companies to proactively address certain key areas that are likely to draw enforcement action, including physician speaker programs and data integrity, say attorneys at Buchanan Ingersoll.
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4 Considerations In Light Of Cyber Incident Notification Bill
Following the recent introduction of a bipartisan bill that would require government contractors and critical infrastructure operators to report cyber intrusions to the federal government within 24 hours, companies should take several steps to assess their preparedness for identifying vulnerabilities and mitigating the risk of cyberattacks, say attorneys at Squire Patton.
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What COVID-19, Social Issues Mean For Pharma Case Juries
Recent surveys of actual and potential jurors suggest that the turbulence of this time will likely affect the attitudes of juries in pharmaceutical and life science cases in at least five different ways, say Buffy Mims and Rachel Horton at DLA Piper, and Rick Fuentes at R&D Strategic Solutions.
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Health Cos. Must Prepare For Growing Ransomware Threat
Health companies are a prime target for ransomware attacks due to their sensitive data and relative vulnerability, so they will need compliance and resilience to guard against the increasingly varied ways that hackers can attempt to extract funds, say Alaap Shah and Stuart Gerson at Epstein Becker.
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Medical Device Cases Show Increased Sunshine Act Scrutiny
Recent U.S. Department of Justice and Centers for Medicare & Medicaid Services settlements with two medical device manufacturers signal ramped-up enforcement of the Sunshine Act, highlighting a departure from a historically gentler approach, say Jaime Jones and Brenna Jenny at Sidley.
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Compliance Considerations For Pharma Co. Testing Programs
Diagnostic tests sponsored by pharmaceutical companies can provide real benefits to patients, but should be carefully structured to mitigate compliance risks related to possible fraud and patient privacy, say Eve Brunts and Alison Fethke at Ropes & Gray.
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Gov't Authorities Should Assist Ransomware Targets
As more companies make the prudent decision to pay ransoms following cyberattacks — recently demonstrated by Colonial Pipeline's decision to make a multimillion-dollar payment — governments should use these opportunities to identify and punish perpetrators, rather than simply admonishing victims, say attorneys at Clifford Chance.
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Bracing For The Next Wave Of Health Care Enforcement
Health companies should take proactive steps against a coming wave of federal enforcement, in light of massive new health funding, agencies' desire to protect COVID-19 relief funds, increased use of data analytics and a likely rise in qui tam suits, say attorneys at Foley & Lardner.
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Indoor Air Pollution Fix Will Require New Laws, New Tech
The COVID-19 pandemic, an aging population and changing workplace dynamics all foretell more exposure to indoor air pollutants, so a multidisciplinary policy approach combining technology, insurance, funding and regulation will be needed to improve indoor air quality and health, says Ann Al-Bahish at Haynes and Boone.
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How Justices' AMG Ruling Affects Privacy And Cybersecurity
The U.S. Supreme Court's recent ruling in AMG Capital Management v. Federal Trade Commission removes the regulator's ability to seek monetary damages that discouraged privacy and cybersecurity breaches, and as a result, companies should reassess their exposure in these areas, say attorneys at Orrick.
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COVID's Int'l Trade Impact Holds Health Co. Legal Implications
Pandemic-prompted changes to international trade are highlighting novel legal issues related to the health care industry's reliance on an international supply chain, the proliferation of counterfeit supplies, and risks associated with offshoring administrative support, say Brett Johnson and Claudia Stedman at Snell & Wilmer.