Digital Health & Technology
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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.