Digital Health & Technology
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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.
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May 03, 2024
Ala. High Court Won't Rethink Decision On Frozen Embryos
The Alabama Supreme Court on Friday refused to revisit its February decision finding that frozen embryos count as children, a first-of-its-kind decision that has been received as potentially ruinous for in vitro fertilization services in the Yellowhammer State.
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May 02, 2024
Walgreens Fights $1B Arb. Award Over COVID Test Contract
At-home lab test maker Everly Health urged a Delaware federal judge to affirm its nearly $1 billion arbitration award against Walgreens over claims the pharmacy chain deliberately misused the digital health platform's trademark while secretly diverting COVID-19 tests to its own pharmacists while Walgreens argued the arbitrator overstepped his authority in bestowing such an "egregious" award.
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May 02, 2024
Masimo Hit With Derivative Suit Over Audio Co. Acquisition
The top brass at medical device company Masimo Corp. has been hit with a shareholder derivative action claiming they harmed the company and "confused" investors by pushing through a $1 billion acquisition of an audio equipment company, allegedly causing a steep drop in stock prices and a $5.1 billion market capitalization loss.
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May 02, 2024
Lawmaker Wants Antitrust Probe Of Health Insurance Data Co.
Sen. Amy Klobuchar, D-Minn., is calling for antitrust enforcers to investigate concerns that MultiPlan and other healthcare data companies are hurting competition by helping health insurers effectively collude when making pricing decisions.
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May 01, 2024
Sens. Slam UnitedHealth's Security Lapses, Breach Response
UnitedHealth's top executive faced heavy criticism during his first appearance before a U.S. Senate committee since a cyberattack rocked its Change Healthcare subsidiary, with lawmakers blasting the company for lacking basic security measures and for still not being able to confirm the scale and scope of the incident.
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April 30, 2024
What's Behind the Q1 Digital Health Funding Rebound
The digital health industry saw a resurgence in funding at the start of 2024, driven by a handful of mega-rounds and growing deal sizes across the board, but it also faced record-low deal counts as investors signaled pickier attitudes over which ventures they're choosing to fund.
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April 30, 2024
Patients Sue NC Plasma Donation Co. Over Data Breach
A plasma collection company has been hit in North Carolina federal court with at least two proposed class actions as of Monday claiming it failed to safeguard patient data, resulting in a breach in which names, Social Security numbers, addresses and treatment information were allegedly exposed by hackers.
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April 30, 2024
Tougher Privacy Rule Won't End Abortion Data Fight
Healthcare attorneys welcomed enhanced federal protections for patient abortion records. But the new rule likely won't release providers from the bind of complying with federal privacy law while potentially facing out-of-state probes into sensitive patient information.
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April 29, 2024
UnitedHealth's Cyberattack Response Is 'Inadequate,' AGs Say
Nearly two dozen state attorneys general urged UnitedHealth Group and its subsidiary Change Healthcare "to do more" to address the fallout from a February cyberattack by Russian ransomware group Blackcat that breached their systems and services, noting their response efforts to the outage "have been inadequate."
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April 29, 2024
Amid Backlash, FDA Extends Control For Lab-Developed Tests
The U.S. Food and Drug Administration inked a final rule Monday that gives the agency broad authority over lab-developed tests by classifying them as medical devices, a move that has drawn ire from congressional leadership and those in the healthcare and life sciences industries.
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April 29, 2024
AI Pharma Co. Sued By Investor Over Handling Of Fired CEO
Artificial intelligence-driven pharmaceutical company Exscientia PLC has been hit with a proposed class action alleging its former CEO engaged in inappropriate personal relationships with employees, and that the company's chairman knew but concealed it.
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April 29, 2024
Philips Inks $1.1B Deal To Resolve CPAP Injury Claims
The plaintiffs' attorneys leading a multidistrict litigation against Koninklijke Philips NV and some of its American subsidiaries announced Monday that they had reached a $1.1 billion settlement agreement for plaintiffs claiming that degraded foam in their breathing machines caused them personal injuries or will require long-term medical monitoring.
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April 26, 2024
Ill. Hospital Wins Dismissal Of Genetic Privacy Case
An Illinois state court judge has thrown out a proposed class action accusing Advocate Health and Hospitals Corp. of violating the state's decades-old genetic information privacy law, saying Wednesday the lead plaintiff not only released the hospital system from liability, but was largely asked about her own medical status after she was already offered a job.
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April 25, 2024
Stryker Says Sanctions Bid Goes 'Galaxies Beyond' Law
Medical device maker Stryker urged a Colorado federal judge to reject an ex-distributor's latest request for sanctions, arguing in a brief that the distributor's $2.2 million bid goes "galaxies beyond" what it asked for at trial and what the Tenth Circuit said the court could entertain.
Expert Analysis
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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.
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A Phased Approach To In-House Legal Tech Adoption
In-house legal departments that adopt new technologies too quickly often face frustration or failure, so to help ensure a smooth transition, companies should consider a multistep approach, depending on where they stand with respect to modernizing legal processes, says Tariq Hafeez at LegalEase Solutions.
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3 Practice Tips For Patenting Medical Devices In A Digital Age
In light of a recent surge in digital therapeutic applications that help manage or treat diseases, there are several best practices to follow when patenting medical devices and software, including improving upon existing technology and making the claims as specific as possible, say attorneys at Crowell & Moring.
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How To Minimize FCA Cyber Fraud Enforcement Risk
As the U.S. Department of Justice’s new Civil Cyber-Fraud Initiative signals a rise in False Claims Act enforcement and whistleblower actions for cybersecurity-related fraud, government contractors and grantees should take five preventative steps to mitigate increased risks, say Brenna Jenny and Sujit Raman at Sidley.
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What Blockchain Means For The Future Of US Health Care
As the U.S. plays catchup with other countries that have introduced blockchain into their health care systems, the technology is poised to drastically change the industry's revenue cycles, data management and beyond, which will result in better care for patients and more assurance for provider reimbursements, say Michael Ruggio and Jacob Butz at Ice Miller.
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How To Navigate California's New Intrastate CBD Route
Businesses and consumers should prepare for rigorous compliance checks on manufacture, distribution and retail sale of consumer products made with CBD and other hemp-derived cannabinoids. following California's new law opening the potentially enormous market for these items, says Christian Foote at Clark Hill.
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Manufacturers Face Evolving COVID-19 Legal Challenges
Product manufacturers must adopt new strategies to defend against pandemic-related legal challenges, including discovery delays in health care litigation, novel consumer protection claims, aggressive government enforcement actions and supply chain disputes, says Stephanie Laws at Maslon.
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FTC's Hasty Health Data Rule Change Could Cause Confusion
The Federal Trade Commission's recent policy statement expanding the scope of its Health Breach Notification Rule appears to bypass appropriate administrative processes and may delay effective privacy and security policies that can advance interoperability and health innovation, says Jodi Daniel at Crowell & Moring.
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'McMorris Factors' Create Obstacles For Data Breach Plaintiffs
The factors for evaluating standing in the context of data breach allegations set forth by the Second Circuit in McMorris v. Carlos Lopez & Associates earlier this year may be difficult, if not impossible, for plaintiffs to satisfy, but the standard varies from circuit to circuit, say David Topol and Pamela Signorello at Wiley.
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Telehealth Providers Must Beware Of Fraud As Industry Grows
A recent fraud charge against a telehealth executive highlights the rise we're seeing in telefraud scams during the industry's pandemic growth, and there are some steps that all health providers should take to stay clear of potentially illegal arrangements, says LaTawnda Moore at Dinsmore.
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The Regulatory Growing Pains For Digital Health Companies
The meteoric rise of digital health services during the pandemic has been matched with increasing regulatory scrutiny in the U.S. and abroad, resulting in a patchwork of laws and approaches that could leave a damper on the industry's growth, say attorneys at Kobre & Kim.
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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.