Digital Health & Technology

  • February 20, 2024

    Ala. Justices Deem Frozen Embryos Children Under State Law

    The Alabama Supreme Court ruled that frozen embryos count as children in a first-of-its-kind decision bemoaned by advocates and a dissenting judge as potentially ruinous for in vitro fertilization services in the state. 

  • February 20, 2024

    FDA Flags 'Alarming Trend' Of Bad Data In Med Device Testing

    The Food and Drug Administration warned medical device manufacturers Tuesday that it has spotted an uptick in fraudulent data submitted by applicants seeking approval for new devices, an "alarming trend" the agency said could harm patients' access to vital medical equipment.

  • February 20, 2024

    Biology AI Startup Bioptimus Raises $35M Seed Round

    Artificial intelligence startup Bioptimus has raised $35 million to build an AI foundational model focused on biology, the company announced Tuesday.

  • February 20, 2024

    Fed. Circ. Backs Microsoft's PTAB Win Over 3D Patents

    The Patent Trial and Appeal Board properly invalidated a pair of 3D medical imaging patents challenged by Microsoft, the Federal Circuit affirmed Tuesday.

  • February 15, 2024

    7th Circ. Rejects Ancestry.com's Arbitration Bid In Privacy Suit

    The Seventh Circuit on Thursday upheld a lower court's decision that minors suing Ancestry.com for sharing their genetic testing information can avoid arbitration, saying there was no language in the terms their parents signed designating the children as parties to the agreement.

  • February 15, 2024

    House Committee Blasts VA, Oracle For E-Record Failures

    Lawmakers on Thursday rebuked the U.S. Department of Veterans Affairs and Oracle Corp. for inadequate fixes to electronic medical records systems that they say continue to threaten the health and safety of thousands of veterans, who are not being advised of the risk.

  • February 15, 2024

    Med Monitoring Claims In Philips MDL Sent Back For Review

    The judge overseeing multidistrict litigation over Koninklijke Philips NV's recalled breathing machines has declined a special master's recommendation to trim claims seeking medical monitoring for some users, instead sending the case back for a deeper look at which states would allow such claims or whether they required proof of physical injury.

  • February 14, 2024

    Telehealth Advocates Press DEA On Prescription 'Red Flags'

    Several telehealth providers, policy organizations and a technology company joined forces to urge the U.S. Drug Enforcement Administration to provide "explicit guidance" to pharmacists about filling prescriptions for controlled substances that result from telehealth visits. 

  • February 14, 2024

    Mo. Hospital Faces Action Over Breach Of 500K Patients' Data

    A Missouri hospital has been hit with a proposed class action after allegedly taking five months to notify more than 500,000 patients that their sensitive information had been compromised, according to a complaint filed in Missouri federal court.

  • February 14, 2024

    NYC Sues Facebook, Social Media Cos. Over Teen Addiction

    New York City on Wednesday became the latest government entity to accuse social media giants such as Facebook, TikTok and YouTube of purposefully hooking youth on their platforms and driving a mental health care crisis by designing their apps to mimic gambling and tobacco industry tactics in a California state court suit.

  • February 14, 2024

    Software Co. Inks $4M Deal In Privacy Suit Over Breached Info

    Patients suing software company Connexin Software for allegedly failing to safeguard the healthcare and personal identifiable information of more than 200,000 people compromised during a data breach, including that of children, asked a Pennsylvania federal judge on Wednesday to approve a $4 million class settlement.

  • February 14, 2024

    Dad Sues Hacked Chicago Children's Hospital Again

    A plaintiff already suing Ann Lurie Children's Hospital over alleged negligence in managing its medical records has again targeted the Chicago hospital, claiming it didn't do enough to protect patient data from hackers who have stymied hospital operations for weeks. 

  • February 13, 2024

    LabCorp Sued Over Sharing Sensitive Health Info With Google

    The Laboratory Corporation of America shares sensitive health information and website browsing history with Google without patients' knowledge or consent, according to a proposed class action filed Tuesday in Pennsylvania federal court.

  • February 13, 2024

    Billing Cos. Deny Claims By Health Facility In $7M Fraud Case

    Three medical billing companies are fighting a suit by a mental health treatment facility alleging their "incompetence" cost it roughly $7 million in lost revenue and damages, telling a Connecticut federal judge that the facility wrongly terminated their agreement.

  • February 13, 2024

    Texas Appeals Court Grants Medical Coding Co.'s Atty Fee Bid

    A Texas appellate panel has ordered a diagnostics business to pay a medical coding company's attorney fees following a contract dispute between the companies, issuing a judgment Tuesday that also affirmed a trial court's decision to grant the coding company summary judgment.

  • February 13, 2024

    Nava Health To Go Public Via $320M SPAC Merger

    Health clinic chain Nava Health is planning on going public through a merger with blank-check company 99 Acquisition Group in a $320 million deal led by two law firms, the companies announced Tuesday.

  • February 13, 2024

    Convicted NC Doctor Can't Get Recordings From Prosecutors

    A North Carolina federal judge on Tuesday rejected a doctor's attempt to force prosecutors to turn over recorded phone calls with a telemedicine provider, finding that the requested materials weren't relevant and that she was trying to "manufacture" a way to have her fraud conviction overturned.

  • February 12, 2024

    GAO Says Ambiguity Protest Too Late In HHS Comms Deal

    A Virginia-based communications firm lost out on a marketing contract for the U.S. Department of Health and Human Services after the U.S. Government Accountability Office ruled that it had not provided a required rate agreement in its quote.

  • February 12, 2024

    FDA Seeks Comment On Guidance For Clinical Trial Sponsors

    The U.S. Food and Drug Administration is set to publish draft guidance on Tuesday that aims to help clinical trial sponsors determine when they need to bring in a group of data experts to review the information being collected in a clinical trial. 

  • February 09, 2024

    Healthcare Cybersecurity Bill Puts Focus On HHS Oversight

    Members of a U.S. Senate cybersecurity commission introduced a bill Friday that would require federal health officials to conduct regular evaluations of digital security systems and issue biennial reports to Congress.

  • February 09, 2024

    Mental Health App Says Former Exec Can't Lead Rival

    Therapy app company SonderMind Inc. has filed a lawsuit in Denver state court alleging a former chief medical officer is violating a non-compete clause he signed by taking an identical role at rival company Rula Health.

  • February 09, 2024

    HHS Establishes Rule For Release Of Substance Use Records

    Records of a patient's substance use treatment may be more easily shared among healthcare providers under a massive new rule issued by the U.S. Department of Health and Human Services, a step the agency said will help coordinate and improve patient care.

  • February 09, 2024

    23andMe Led To Late Father And $28M Verdict, Woman Says

    A Massachusetts woman's successful quest to learn her father's identity through the ancestry-tracking company 23andMe took a surprising turn when she later learned her new flesh-and-blood relatives left her out of her father's wrongful death suit that resulted in a $28 million jury verdict, according to a state court lawsuit.

  • February 08, 2024

    AI Shouldn't Stay In 'Ivory Tower,' Health Experts Tell Sens.

    U.S. Senators on Thursday heard from experts from Stanford University and other institutions on how to ensure that healthcare benefits promised by artificial intelligence, from improved patient outcomes to lower costs, do not remain confined to the "ivory tower" but instead reach underresourced hospitals.

  • February 08, 2024

    Broker Hit With Suit Over Data Breach Affecting 1.5 Million

    A California insurance broker is facing a proposed class action filed Thursday in federal court accusing the company of failing to keep the health and personal information of more than 1.5 million customers safe from exposure in an August cyberattack.

Expert Analysis

  • Tips For In-House Legal Leaders In A Challenging Economy

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    Amid today's economic and geopolitical uncertainty, in-house legal teams are running lean and facing increased scrutiny and unique issues, but can step up and find innovative ways to manage outcomes and capitalize on good business opportunities, says Tim Parilla at LinkSquares.

  • Health Providers Must Beware FCA Risks When Using AI

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    Though recent innovations in artificial intelligence can potentially bring increased productivity, greater efficiency and reduced costs to the healthcare industry, providers must take appropriate precautions to avoid risks and potential False Claims Act liability, says Sara Lord at Arnall Golden.

  • New Considerations In Med Device Cybersecurity Compliance

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    Recent guidance from the U.S. Food and Drug Administration clarifies premarket submission procedures related to medical device cybersecurity, and indicates a significant expansion in the agency's expectations surrounding risk management practices for both manufacturers and providers, says Meghna Parikh at Buchalter.

  • Federal Oversight Of AI In Healthcare Is Taking Shape

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    A recent proposed rule from the U.S. Department of Health and Human Services provides early insights into how the federal government intends to oversee artificial intelligence and machine learning in healthcare, highlighting priorities like transparency, equity and potential kickback implications, say attorneys at Hooper Lundy.

  • A Close Look At Pennsylvania's Data Breach Law Changes

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    New amendments to Pennsylvania's Breach of Personal Information Notification Act will hold state agencies to stricter notification requirements more in line with those in other states, and will allow entities to determine a breach has occurred before their notification obligations take effect, says Lauren Godfrey at Constangy.

  • Abortion Pill Rulings Will Hinder FDA Authority

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    Although the Fifth Circuit recently stayed a Texas federal court's ruling that invalidated the U.S. Food and Drug Administration's approval of a commonly used abortion medication, several points made by the courts are worth considering for their potentially chilling effect on FDA authority and the challenges they may create for the life sciences industry, say attorneys at Morgan Lewis.

  • Key Guidelines For Conducting Clinical Trials Overseas

    Excerpt from Practical Guidance
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    Conducting clinical trials outside the U.S. offers many benefits to researchers, but these benefits come with countervailing ethical and legal challenges that must be carefully addressed, say attorneys at Bass Berry.

  • Recent Growth Factors Driving Life Sciences Transactions

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    In view of challenges posed by last year's economic downturn, life sciences companies have increasingly turned to collaboration and licensing arrangements, with a focus on deal activity in artificial intelligence, digital health and gene therapy, say attorneys at Ropes & Gray.

  • How Cannabis Cos. Can Keep Up With Privacy Compliance

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    With the cannabis industry's rapid growth and access to sensitive consumer information, and the ever-changing patchwork of state data privacy laws, it is becoming increasingly important for marijuana businesses to treat cybersecurity as a significant risk and management priority, say attorneys at Goodwin.

  • FTC's Health Privacy Actions Offer 5 Advertising Takeaways

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    The Federal Trade Commission's recent enforcement actions against GoodRx and BetterHelp highlight the need for any company engaging in common online advertising practices to pay close attention to the personal information they collect and share with third parties, say Kate Black and Sam Castic at Hintze Law.

  • States Shouldn't Fear HIPAA When Improving Gov't Services

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    As the looming end of the COVID-19 public health emergency motivates states to streamline their processes for individuals seeking public benefits, they should generally not have to worry about violating the Health Insurance Portability and Accountability Act when sharing data across government services, says Jodi Daniel at Crowell & Moring.

  • 5 Data Privacy Practices Cos. Should Implement Now

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    Businesses that are not subject to a comprehensive data privacy law should nevertheless consider implementing privacy practices that are consistent with current norms to help mitigate both common law exposure and an expensive rush to compliance if a federal law is passed, say John Rolecki and Alexander Thibodeau at Varnum.

  • Privacy Lessons From FTC's BetterHelp Consent Decree

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    The Federal Trade Commission's recent enforcement action against BetterHelp highlights the growing risk associated with the use of third-party cookies and pixels on websites for companies that offer health services, say Rachel Marmor and Shannon Hartsfield at Holland & Knight.