Digital Health & Technology
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October 31, 2023
HHS Proposes Monetary Sanctions For Information Blocking
Health care providers would face monetary disincentives for engaging in information blocking under a proposed rule by the U.S. Department of Health and Human Services.
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October 30, 2023
Health Systems Say Meta Data-Sharing Suit Lacks Substance
A group of medical systems asked a California federal judge Friday to toss a proposed class action alleging they "disregarded the privacy rights" of millions of visitors to their websites by sharing user data with Meta without users' knowledge through third-party tracking technologies.
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October 27, 2023
Rush University Hospital Sued Over Worker Fingerprint Scans
A respiratory therapist has hit his former employer, a Chicago hospital, with a proposed class action in Illinois state court alleging a violation of the state's Biometric Information Privacy Act over its use of fingerprint scanning to access medicine and supply dispensing machines.
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October 27, 2023
Costco Gave Meta Customers' Medical Info, Class Action Says
Costco disclosed customers' personal health information to third parties, such as Meta, through the use of tracking tools on its website, a proposed class action has alleged in Washington federal court.
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October 26, 2023
Sofinnova Partners Closes $200M Digital Medicine Fund
European life sciences investment firm Sofinnova Partners said Thursday that it has closed its first digital medicine fund, raising $200 million.
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October 25, 2023
Oregon Insurer, Others Hit With Suit Over Russian Hack
An Oregon Medicaid customer has launched a proposed class action in federal court against a coordinated care organization and its vendor, as well as a Massachusetts-based software company, alleging the companies failed to take steps to keep her data safe from Russian hackers.
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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.
Expert Analysis
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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.
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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.