Digital Health & Technology

  • October 25, 2023

    FDA Plans Tighter Scrutiny Of Off-Label Data Sent To Doctors

    The U.S. Food and Drug Administration is preparing more stringent guidelines on how pharmaceutical companies and similar firms should communicate with doctors about research into the off-label use of medical devices and drugs.

  • October 24, 2023

    Colo. Medicaid Agency, IBM Hit With Data Breach Class Action

    A Colorado man has filed a proposed class action in state court against the Colorado Department of Health Care Policy and Financing and IBM over a software vulnerability that allegedly allowed a hacker to obtain the personal information of more than 4 million people.

  • October 24, 2023

    Med-Tech Co. UpHealth And 6 Units Get OK For Joint Ch. 11

    Digital health care company UpHealth Holdings Inc. can include six affiliates offering psychiatric treatment and other services in its bankruptcy case, a Delaware bankruptcy judge said Tuesday, more than a month after the debtor hit Chapter 11 citing the fallout of a failed legal battle with former financial adviser Needham & Co. LLC.

  • October 24, 2023

    Consumer Says Contractor's Software Allowed Data Hack

    A Texas woman has accused a federal contractor that helps process online Medicaid information of not doing enough to prevent a data breach that leaked patients' personal information, claiming Russian hackers exploited software vulnerabilities the contractor should have foreseen.

  • October 20, 2023

    UK Litigation Roundup: Here's What You Missed In London

    The past week in London has seen credit score agency Equifax hit with a class action suit over a data breach compromising 14 million consumers’ data, scuppered law firm High Street Solicitors accused by a fund management company of breaching its contract, and Lenovo bring its 5G patent dispute with Ericsson to the High Court. Here, Law360 looks at these and other new claims in the U.K.

  • October 18, 2023

    33 AGs Ink $1.4M Deal With Clearinghouse Over Data Breach

    Health care clearinghouse Inmediata has agreed to pay $1.4 million to 32 states and Puerto Rico to resolve claims that it failed to adequately safeguard the sensitive health information of approximately 1.5 million consumers that was left publicly exposed online for almost three years, several state attorneys general announced Tuesday.

  • October 18, 2023

    MVP: Sheppard Mullin's Eric Klein

    Eric Klein of Sheppard Mullin Richter & Hampton LLP represented VillageMD through its $8.9 billion acquisition of Summit Health-CityMD, the largest health care services transaction of 2022, earning him a spot as one of Law360's 2023 Health Care MVPs.

  • October 16, 2023

    Smart Medical Device Maker Inks $60M SPAC Merger

    Smart medical device developer Docter is planning on going public through a merger with Aimfinity Investment Corp. in a deal led by two law firms and worth a targeted $60 million, according to a statement from Aimfinity on Monday.

  • October 13, 2023

    Calif. Raises Data Broker Regulation Bar With Deletion Law

    California is putting data brokers under the microscope with a groundbreaking law that imposes significant new data deletion and disclosure obligations, creating heightened liability risks and once again establishing a privacy standard that other states are likely to follow. 

  • October 13, 2023

    Patients, Health Co. Settle Data Breach Suit For $2.9M

    A class of people caught up in a 2022 data breach asked a Michigan federal judge on Friday to preliminarily approve a $2.9 million deal with a maker of prosthetics and orthotics to settle claims that the company didn't adequately protect their sensitive information from a cyberattack.

  • October 11, 2023

    FDA Launches New Digital Health Advisory Committee

    The U.S. Food and Drug Administration said Wednesday it's creating a new committee to advise on the use of digital technologies like artificial intelligence and remote monitoring in health and medicine, signaling the growing importance of digital health for business and regulators.

  • October 10, 2023

    23andMe Didn't Protect Sensitive Info From Hacker, Users Say

    Biotechnology company 23andMe didn't have in place adequate safeguards to protect the genetic ancestry data and other sensitive information of thousands of customers from a data breach the company announced last week, according to a proposed class action filed Monday in California federal court.

  • October 10, 2023

    Network Says Patients, Employees Not Injured By Data Breach

    A network of dental practices on Monday urged a Michigan federal judge to toss a suit alleging it didn't keep patients' and employees' personal information safe from a cyberattack, saying the proposed class has not shown they have suffered a real-world injury from the data breach.

  • October 10, 2023

    Cooley Adds Foley & Lardner Life Sciences Atty In San Diego

    Cooley LLP has hired a longtime Foley & Lardner LLP life sciences partner, who will join the firm's health care transaction group in its San Diego office, the firm announced Monday.

  • October 06, 2023

    Mich. Health Co. 'Reckless' With 2.5M Patients' Info, Suit Says

    Michigan health system McLaren Health Care Corp. was hit with a federal lawsuit after a ransomware attack allegedly compromised the personal information of around 2.5 million patients.

  • October 06, 2023

    DEA Issues 2nd Extension Of Telehealth Prescription Rule

    The Drug Enforcement Administration on Friday extended for the second time a temporary COVID-19 era rule allowing providers to prescribe controlled substances without first seeing a patient in person, keeping the status quo in place through the end of 2024 while the agency hashes out plans on a final rule. 

  • October 05, 2023

    IP Forecast: Novartis To Fight Antitrust Row Over Drug Patent

    Novartis is set to oppose an appeal at the Second Circuit from a rival seeking to restore an antitrust suit accusing it of hiding things from the patent office to illegally corner the market for an eye syringe treatment. Here's a look at that case — plus all the other major intellectual property matters on deck in the coming week.

  • October 05, 2023

    Blackbaud To Pay States, DC $49.5M For Data Breach Claims

    Blackbaud Inc. has agreed to pay $49.5 million to resolve claims brought by 49 states and the District of Columbia over the software company's security practices and its response to a 2020 ransomware attack that affected thousands of its customers, the parties said Thursday.

  • October 04, 2023

    Suit Says BCBS Of Ill. Failed To Protect Data In Breach

    Blue Cross Blue Shield of Illinois was hit with a putative class action Tuesday alleging it failed to implement safeguards that would have protected members' personal, sensitive information from being disclosed through a third-party vendor and took nine months to discover there was a breach.

  • October 03, 2023

    Google Says It Didn't Use Data From Period App To Advertise

    Google has told a California federal court it should dismiss a proposed class action alleging the company used a data analytics tool to wrongfully retrieve data from a menstruation tracking app because the tech giant didn't use the data to produce targeted advertising.

  • October 02, 2023

    Sutter Health Emails Reveal Billing Confusion In $519M Trial

    Internal Sutter Health emails shown Monday during a whistleblower's $519 million California bench trial over double-billing claims revealed that the hospital systems' personnel regularly asked Sutter compliance administrators how they should charge patients and insurers for certain recovery room and operating room services, and expressed concerns over potentially inconsistent billing practices.

  • September 28, 2023

    Cedars-Sinai Tells 9th Circ. Data Suit Belongs In Federal Court

    Cedars-Sinai is urging the Ninth Circuit to block the remand to state court of a trio of consolidated suits accusing it of improperly sharing patients' personal information with tech giants like Facebook, arguing the dispute "requires a federal forum to resolve" because it's premised on the provider's efforts to carry out a federal government-backed initiative to improve health technology infrastructure.

  • September 26, 2023

    Miss. Orthopedic Group Sued For Patient Data Hack

    A Mississippi orthopedic care provider was hit with a federal lawsuit Monday in the state after a data breach allegedly compromised the personal information of around 242,986 patients.

  • September 25, 2023

    IBM, J&J Face Class Action Over August Patient Data Breach

    IBM and the health care arm of Johnson & Johnson were hit with a proposed class action in New York federal court alleging their failure to safeguard protected health information resulted in a data breach on Aug. 2 that impacted thousands of patients who weren't told of the breach until Sept. 15.

  • September 25, 2023

    PharMerica Unit Hit With Data Breach Class Action In Calif.

    Pharmacy services company Amerita Inc., a subsidiary of PharMerica, was hit with a putative class action in California federal court Monday by a patient who accused the company of failing to implement protocols to protect sensitive information from cyberattacks and data breaches, and waiting nearly six months to inform impacted customers.

Expert Analysis

  • Policyholder Best Practices As Cyberattacks Escalate

    Author Photo

    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.

  • Navigating Asia-Pacific Health M&A In The Wake Of COVID

    Author Photo

    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.

  • Life Sci Cos. Should Prep For Enforcement After COVID Pause

    Author Photo

    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.

  • 4 Considerations In Light Of Cyber Incident Notification Bill

    Author Photo

    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.

  • What COVID-19, Social Issues Mean For Pharma Case Juries

    Author Photo

    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.

  • Health Cos. Must Prepare For Growing Ransomware Threat

    Author Photo

    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.

  • Medical Device Cases Show Increased Sunshine Act Scrutiny

    Author Photo

    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.

  • Compliance Considerations For Pharma Co. Testing Programs

    Author Photo

    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.

  • Gov't Authorities Should Assist Ransomware Targets

    Author Photo

    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.

  • Bracing For The Next Wave Of Health Care Enforcement

    Author Photo

    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.

  • Indoor Air Pollution Fix Will Require New Laws, New Tech

    Author Photo

    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.

  • How Justices' AMG Ruling Affects Privacy And Cybersecurity

    Author Photo

    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.

  • COVID's Int'l Trade Impact Holds Health Co. Legal Implications

    Author Photo

    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.