Digital Health & Technology

  • December 08, 2023

    New Drug Patent Proposal Sparks Worry Over Gov't Overstep

    The Biden administration's proposal to seize drug patents if the prices of the medicines are deemed unreasonable is expected to face significant legal pushback, and the potential effects on the pharmaceutical industry may not be what the administration had in mind, experts say.

  • December 07, 2023

    NC Radiology Group, Broker Strike Deal In Cyberattack Row

    A North Carolina radiology practice told a federal court Thursday it struck a deal with its insurance broker resolving its suit alleging it lost more than $1 million as a result of a ransomware attack that occurred shortly after the broker allowed cyber liability coverage to lapse.

  • December 06, 2023

    Wellness or Medical? Device-Maker Attys Look for Answers

    To be or not to be a medical device? That is the question attorneys are navigating with healthcare entrepreneurs seeking to market innovations incorporating artificial intelligence and digital technologies, and one that may help them avoid conflicts with U.S. Food and Drug Administration guidelines.

  • December 06, 2023

    Hospital Group Explores 'Responsible' Health Data Privacy

    The Joint Commission, a healthcare accreditation nonprofit, launched a new health data privacy certification program on Wednesday that aims to train hospitals on protecting patient privacy while transferring the data to third-party organizations for secondary use.

  • December 06, 2023

    HHS Offers Plan To Bolster Hospital Defenses In Cyberattacks

    The Centers for Medicare and Medicaid Services will propose new cybersecurity requirements for hospitals in an effort to implement greater accountability in the healthcare industry, the federal government announced Wednesday.

  • December 06, 2023

    NC Biz Court Trims Suit Claiming Hospital Sold Data To Meta

    North Carolina's business court allowed a proposed class action against WakeMed Health & Hospitals to move forward after finding the plaintiffs adequately alleged claims of common-law negligence, breach of implied contract and breach of fiduciary duty in a suit claiming the hospital system sold patient data to Meta Inc. without consent.

  • December 05, 2023

    Massive Hack At 23andMe Got Health, DNA Ancestry Data

    Hackers accessed data from about 6.9 million users of the DNA testing company 23andMe Inc., the company confirmed Tuesday. The breach got a wealth of sensitive information, including health and DNA ancestry profiles.

  • December 04, 2023

    Patients Sue Nevada Healthcare Vendor For Exposing Data

    Two patients of an Illinois healthcare system filed a proposed class action against a Nevada medical transcription firm, alleging that the company failed to protect sensitive health information, even though the healthcare sector is a favorite target for hackers.

  • December 04, 2023

    Blank-Check Co. Aimei Health Technology Prices $60M IPO

    Aimei Health Technology, a blank-check company focused on healthcare targets, priced its initial public offering at $60 million on Friday ahead of its Monday listing on the Nasdaq, offering 6 million units at $10 apiece.

  • November 30, 2023

    MOVEit Hack MDL Needs 'Structure,' Judge Tells Atty Gaggle

    A federal district judge tapped to oversee the multidistrict litigation in a massive data breach involving Progress Software Corp.’s MOVEit transfer program told dozens of lawyers in a packed Massachusetts courtroom Thursday that she plans to choose class leaders by the beginning of January.

  • November 29, 2023

    House Told AI Is A Tool, Not A Decision Maker, In Health Care

    Amid expanding innovations in artificial intelligence in the health care industry, from AI scribes of patient visits to algorithm-driven medical imaging, experts are urging lawmakers to develop regulation and oversight to avoid compromising patient safety and privacy.

  • November 29, 2023

    Investors Say Co. Lied About Ultrasound Tech Prior To Merger

    A pair of shareholders in digital health company Butterfly Network Inc. have launched a derivative suit against the company's current and former top brass, alleging they drastically inflated the company's sales projections and the quality of its main ultrasound product to convince investors to approve a merger with a special-purpose acquisition company.

  • November 29, 2023

    Gov't Contracts Of The Month: Boeing Jets, Robots, IT Deals

    The federal government advanced a $2.5 billion plan to modernize the Indian Health Service's health records system, purchased $2.3 billion more of refueling tankers from Boeing, and is weighing adding robots to its $132 billion fast-paced construction of new nuclear submarines. Here are Law360's top government contracts for November 2023.

  • November 29, 2023

    Patients Lack Standing To Sue Over Email Hack, Ill. Court Says

    An Illinois state appeals court has affirmed the dismissal of two proposed class actions from patients who alleged a large, physician-owned medical group in Illinois failed to safeguard patient data and allowed a hacker to steal information that may include patient Social Security numbers and medical information.

  • November 22, 2023

    Debevoise Attys On AI Potential In Health, 'Iterative' Mistakes

    A growing number of health insurance providers are facing lawsuits targeting their use of an artificial intelligence algorithm in online claims processing. Maura Kathleen Monaghan and Jim Pastore of Debevoise & Plimpton spoke with Law360 about AI automation in insurance claims, auditing and the need for more top-level attention to the technology.

  • November 21, 2023

    Attys Want $4.2M In Fees For Aurora Health Privacy Case

    Attorneys on Monday asked a Wisconsin federal judge to approve their request for a nearly 35% portion of a $12.25 million settlement of a suit against Advocate Aurora Health for disclosing private health information to Google and Facebook.

  • November 20, 2023

    NY-Based Hospital To Pay $80K For HIPAA Violations

    A New York-based medical center on Monday agreed to pay the U.S. Department of Health and Human Services' Office for Civil Rights $80,000 as part of a settlement after the hospital shared protected health information of COVID-19 patients to a national media outlet.

  • November 20, 2023

    Feds ID 330K More Potential Victims In Medicare Data Breach

    The U.S. Centers for Medicare & Medicaid says the personal information of an additional 330,000 patients may have been exposed in a cyberattack carried out earlier this year targeting the file-sharing tool MOVEit.

  • November 20, 2023

    Mich. Health Co. Sued Again Over Breach Spanning 2M People

    Michigan health system McLaren Health Care Corp. was hit with another federal lawsuit claiming it recklessly failed to protect its data systems from a cyberattack in August that allegedly compromised the personal information of over 2 million individuals.

  • November 17, 2023

    NY Health System Accused Of Exposing 3.9M Patients' Data

    New York state's largest health care system Northwell Health Inc.'s failure to protect private information exposed the data of about 3.9 million patients in a recent breach, according to a proposed class action filed in federal court.

  • November 17, 2023

    Fraud, Abuse Remain Top HHS Challenges, Watchdog Says

    A top challenge for the U.S. Department of Health and Human Services remains the potential for abuse of the Medicare and Medicaid programs, the agency's watchdog said in an annual report Thursday.

  • November 17, 2023

    Vaccine Maker Novavax Appoints New COO, CLO

    Novavax Inc., a maker of vaccines for COVID-19 and other diseases, on Friday appointed a president and chief operating officer and announced a new chief legal officer to replace an official who is retiring next month.

  • November 15, 2023

    Meta Seeks Trim Of 'Copycat' Health Privacy Suit

    Meta Platforms Inc. urged a California federal judge Wednesday to shave down a lawsuit alleging the tech giant is illegally receiving consumers' sensitive health information through its Meta Pixel tool, arguing that the suit is a "copycat" of another case the court trimmed in September.

  • November 15, 2023

    NY Hospital Cyber Regs A Balm, Not Cure, For Security Woes

    New York state's proposals for addressing hospital cybersecurity — and providing millions in funding for security upgrades — could help some of the state's smallest hospitals catch up on the latest safeguards and minimum standards against ransomware attacks and data breaches, but they're far from a cure-all for the incidents plaguing health care.

  • November 15, 2023

    UnitedHealth Uses AI To Deny Patient Services, Suit Says

    UnitedHealth knowingly uses an artificial intelligence service with a high error rate to override physician recommendations and deny elderly patients care owed to them through Medicare plans, according to a proposed class action in Minnesota federal court.

Expert Analysis

  • How Growing Cyber Scrutiny Affects Corporate Compliance

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    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.

  • Choosing The Right IP Protections For Telehealth Innovations

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    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.

  • A Phased Approach To In-House Legal Tech Adoption

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    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.

  • 3 Practice Tips For Patenting Medical Devices In A Digital Age

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    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.

  • How To Minimize FCA Cyber Fraud Enforcement Risk

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    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.

  • What Blockchain Means For The Future Of US Health Care

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    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.

  • How To Navigate California's New Intrastate CBD Route

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    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.

  • Manufacturers Face Evolving COVID-19 Legal Challenges

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    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.

  • FTC's Hasty Health Data Rule Change Could Cause Confusion

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    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.

  • 'McMorris Factors' Create Obstacles For Data Breach Plaintiffs

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    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.

  • Telehealth Providers Must Beware Of Fraud As Industry Grows

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    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.

  • The Regulatory Growing Pains For Digital Health Companies

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    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.

  • Policyholder Best Practices As Cyberattacks Escalate

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    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.