Digital Health & Technology
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February 05, 2024
Colo. Software Co. Won't Release Patient Data, Practice Says
A Connecticut-based fertility practice has alleged in Colorado state court that a Denver software vendor has held its patients' records hostage since the two companies mutually agreed to end their business relationship nearly a year ago.
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February 02, 2024
ACLU Atty On How To Protect Civil Liberties In The AI Era
Because artificial intelligence and algorithmic systems often operate in the shadows, there's a new need for legislation, regulation and enforcement to ensure the technology doesn't undercut civil liberties by engaging in discrimination in housing, education or employment, according to Cody Venzke, senior policy counsel for the American Civil Liberties Union.
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February 02, 2024
Ascension Says Medical Queries Don't Breach Genetic Privacy
Questions about family medical history raised during a hospital job interview don't implicate an Illinois genetic privacy law, healthcare giant Ascension Health has told a Missouri federal court.
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February 02, 2024
Groups Urge Probe Into Deloitte's Medicaid Eligibility System
A group of public interest organizations is accusing Deloitte of developing a problematic Medicaid eligibility system that's left beneficiaries in Texas without healthcare coverage, and has asked the Federal Trade Commission to investigate.
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February 01, 2024
DOJ Looking For Privacy Perils In Digital Healthcare
Threats to data privacy and fraud in telemedicine are among federal regulators' top concerns in evaluations of digital healthcare as innovation invites new challenges to protecting patient data and preventing fraud, a U.S. Department of Justice official said Thursday.
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February 01, 2024
Device-Maker Attys Talk FDA Nondevice Rule At Conference
Over a year after the FDA issued its Clinical Decision Support Software guidance for nonmedical devices that describes the agency's approach to medical device software functions, attorneys working in the medical device regulation space are still grappling with the guidance and learning how the FDA is enforcing the regulation.
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February 01, 2024
FTC Puts Cap On Blackbaud's Data Retention In Breach Deal
Blackbaud Inc. has agreed to delete personal data that it doesn't need anymore and boost its data security to resolve the Federal Trade Commission's claims over a 2020 ransomware attack that affected millions of consumers, the commission announced Thursday, marking the latest regulatory action the software provider has settled over the data breach.
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February 01, 2024
Drug Cos. Not Ready for 'Deep End' of Remote Trials
Enthusiasm among drug companies and federal officials about increasing diversity among clinical subjects through "decentralized" trials is being tempered by unknowns about the regulatory landscape, a group of experts said Thursday.
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February 01, 2024
HHS OKs Telehealth, At-Home Flexibility For Opioid Treatment
Federal authorities plan to permanently extend pandemic-era rules that allow patients in opioid treatment programs to take methadone at home and obtain prescriptions for buprenorphine during telehealth visits, as part of an effort to combat opioid addiction.
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January 31, 2024
FDA Has More Cyber Guidance Planned For Device Makers
A U.S. Food and Drug Administration official said Wednesday that further guidance is likely in store in 2024 as the agency marks its first year with the new authority to require device makers to submit cybersecurity compliance plans with applications to bring new healthcare devices to market.
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January 31, 2024
FDA May Have To Cut Activities As Need to Regulate AI Grows
The U.S. Food and Drug Administration may have to pare back functions if Congress doesn't grant it the budget increase it has requested while the agency tries to keep up with rapid developments in the use of artificial intelligence in healthcare.
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January 31, 2024
FDA, Health Experts Talk Int'l 'Harmonization' of AI Regulation
Cross-border compatibility of rules for artificial intelligence-powered medical devices is critical for device makers looking to globalize their products in an evolving regulatory landscape, legal and governmental experts said Wednesday.
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January 31, 2024
Northwell Health Sued Over Breach Of 3M Patients' Data
Northwell Health Inc., New York state's largest health care system, breached its duty to protect sensitive information by failing to keep safe the data of over 3 million individuals in a breach, according to a proposed class action filed Tuesday.
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January 31, 2024
Teladoc Illegally Sends Users' Personal Info To Meta, Suit Says
Teladoc users have filed a putative class action in New York federal court accusing the virtual healthcare giant of privacy invasion for allegedly using a tracking pixel on its website to secretly wiretap their communications and activities, then subsequently sharing their personal information with Facebook without their permission.
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January 31, 2024
Lab Says $7M Stolen Data Is Property And Should Be Covered
A national medical testing lab told a Pennsylvania federal court that patient treatment records and at least $7 million of billing data allegedly hijacked by its software contractor was property and should therefore be covered by its insurer.
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January 31, 2024
Fla. Man Avoids Jail In Telemedicine Fraud Suit
A Florida resident did not receive prison time during a federal court hearing Wednesday and instead was sentenced to a period of supervised release for his role in a company that prosecutors say was built to scam insurers into paying millions of dollars for prescriptions that patients didn't need.
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January 30, 2024
CareFirst Judge Mulls Class OK In Trimmed Data Breach Row
A D.C. federal judge on Tuesday appeared open to the possibility of certifying a class of CareFirst policyholders that would seek only nominal damages against the health insurer for a 2014 data breach that exposed personal information belonging to roughly 1.1 million customers.
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January 30, 2024
NC Hospital Says It Didn't Share Patient Data With Meta
A North Carolina hospital system scoffed at allegations that it shared patient information with Facebook without consent for years in response to a proposed negligence class action brought by three patients and after a state business court allowed the action to move forward.
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January 30, 2024
Stryker Can't Slip California Workers' Wage Suit
Medical device company Stryker cannot escape former workers' wage claims, a California federal judge ruled Tuesday, saying it was unclear whether the company was the workers' employer because it still retained some authority over workers employed by the company's subsidiaries.
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January 29, 2024
Reps Want More From VA On AI Transparency, Enforcement
Members of the House of Representatives on Monday grilled officials from the U.S. Department of Veterans Affairs on how they plan to protect veterans' privacy and ensure transparency in the development and deployment of artificial intelligence models.
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January 29, 2024
Meta Must Keep Battling Trimmed Health Tracking Privacy Suit
A California federal judge on Monday refused to throw out a trimmed version of a lawsuit claiming that Meta Platforms Inc. illegally collected patients' health information using a Facebook data tracking tool, ruling that their latest complaint has addressed some of his prior concerns.
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January 29, 2024
Texas AG Seeks Transgender Patients' Data, Ga. Clinic Says
Georgia-based telehealth clinic QueerMed said Monday that Texas Attorney General Ken Paxton is asking for medical records for patients seeking gender-affirming care, saying the request appears intentional to deter out-of-state clinics from providing such care.
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January 29, 2024
FDA Seeks Input On Reporting Race, Ethnicity In Drug Trials
The Food and Drug Administration asked the healthcare industry Monday for comment on updated guidance that outlines the agency's expectations for collecting race and ethnicity data in drug and medical device research.
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January 29, 2024
Imperative Care Names O'Melveny Deals Partner As CLO
Silicon Valley's Imperative Care announced Monday that an O'Melveny deals partner will take over as chief legal officer, joining a revamped leadership team at the medical tech company.
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January 26, 2024
23andMe Users Say Hackers Targeted Jewish, Chinese Data
Hackers who pushed their way past 23andMe's security systems in a data breach last year were after the personal information of Jewish and Chinese customers, but the biotechnology company hid that detail when notifying 7 million affected customers, according to a proposed class action filed Friday in California federal court.
Expert Analysis
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COVID-19 Vaccines Unlikely To Create Litigation Opportunities
Although COVID-19 vaccines are on the horizon, litigation opportunities may be limited due to the Public Readiness and Emergency Preparedness Act's significant liability protections for not only vaccine manufacturers, but also virtually all entities in the supply chain, say Eric Kraus and Jennifer Shah at Phillips Lytle.
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Overcoming Immunity Of Foreign Gov't Cyberattack Sponsors
To combat the emerging threat of foreign state-sponsored cyberattacks on U.S. businesses and citizens, litigants need to creatively argue for exceptions to immunity under the Foreign Sovereign Immunities Act for foreign governments, say Jerry Goldman and Bruce Strong at Anderson Kill.
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The State Of Consumer Class Actions Amid COVID-19
While the pandemic has slowed the filing of consumer class actions, they remain a significant part of the litigation landscape — with false labeling claims remaining particularly popular, likely because they are easy to file and frequently survive motions to dismiss, say attorneys at Skadden.
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Anticipating The Biden Administration's Health Care Agenda
The Biden administration is unlikely to successfully push sweeping and partisan health care legislation in the next two years, but it will be able to reverse a litany of Trump administration policies pertaining to the Affordable Care Act, reproductive health care and more, say Nick Manetto and Ilisa Halpern Paul at Faegre Drinker.
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What Biden Presidency May Mean For Data Privacy Litigation
The administration of President-elect Joe Biden will likely bring major changes to data privacy law and attendant litigation, including federal legislation that could preempt state laws, renegotiation of conditions for EU data transfers to the U.S., and increased Federal Trade Commission enforcement activity, say attorneys at Squire Patton.
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5 Tips For In-House Counsel Anticipating Cyber Class Actions
In light of a 270% increase in data breaches this year, and the attendant class actions, in-house counsel can prepare to efficiently manage litigation by focusing on certain initial steps, ranging from multidistrict litigation strategy to insurance best practices, say David McDowell and Nancy Thomas at MoFo.
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Where Data Privacy And CFPB Are Headed Under Biden
Data privacy is likely to be a key area of legislative and enforcement focus for President-elect Joe Biden, and consumer financial protection is expected to be an immediate priority due to the economic impact of the pandemic, with the most drastic shift likely to occur at the Consumer Financial Protection Bureau, say attorneys at Gibson Dunn.
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Ethics Considerations For Law Firms Implementing AI
Richard Finkelman and Yihua Astle at Berkeley Research Group discuss the ethical and bias concerns law firms must address when implementing artificial intelligence-powered applications for recruiting, conflict identification and client counseling.
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The Legal Implications Of Mobile Health Advancements
With the pandemic rapidly accelerating the timeline for the shift to remote and mobile health care, providers will need to keep a close eye on new privacy and cybersecurity risks, and on new potential to collect real-time information from patients, say attorneys at Squire Patton.
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The Post-Election State AG Enforcement Landscape
Election results so far have kept the number of Republican and Democratic state attorneys general even, and no matter the outcome of the presidential race, AGs will work across the aisle on important issues like health care, competition and the environment, says former Illinois attorney general Lisa Madigan at Kirkland.
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What A Trump Or Biden Win Will Mean For State AGs
The outcome of the presidential election will have significant consequences on cooperation between federal agencies and state attorneys general, but either way robust multistate investigations — especially in the consumer protection space — will continue, says Sean Riley at Cozen O'Connor.
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Outside Whistleblowers Are Critical To Exposing Fraud
Outsiders like industry experts, competitors, public interest organizations and concerned citizens often have deep knowledge, industry data and financial incentives that put them in a better position than insiders to spot fraud, say attorneys at Youman & Caputo, Fox Rothschild, Goldstein & Russell and Herrera Purdy.
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Comparing Recent State Data Breach Law Updates
Public and private entities should revisit their incident response plans to ensure compliance with and understand the differences among heightened data breach notification requirements that five states and Washington, D.C., added or amended this year, says Jane Petoskey at Polsinelli.