Digital Health & Technology
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December 13, 2023
6 Biggest Healthcare Fraud Cases Of 2023
This year saw a rare False Claims Act jury trial that netted a $490 million verdict, a $172 million settlement from Cigna to settle healthcare fraud allegations, and emerging fraud schemes from developing technologies. Here, Law360 takes a look back at six significant healthcare fraud enforcement actions from 2023.
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December 12, 2023
Ex-Dow Jones Atty Joins Weight Loss Co. Noom As GC
An attorney who provided in-house counsel to Dow Jones for over two decades has joined weight loss company Noom, where he will lead compliance efforts as general counsel.
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December 12, 2023
Point32Health Promotes Veteran Healthcare Atty As CLO
Susan A. Kee is the new chief legal officer at Massachusetts-based Point32Health, a not-for-profit health services organization formed three years ago from the merger of Tufts Health Plan and Harvard Pilgrim Health Care.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Expert Analysis
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FTC's Hasty Health Data Rule Change Could Cause Confusion
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.
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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.