Digital Health & Technology
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April 22, 2024
Watchdog Nixes Unfair Treatment Claims In $310M VA IT Deal
The U.S. Government Accountability Office was unconvinced that the U.S. Department of Veterans Affair graded an IT firm's bid for a $310.3 million deal more harshly than a competitor's, saying the rankings reflected differences in the bids.
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April 19, 2024
Edelson Pitches 'Better Way' To Pick Leads In Privacy Suits
Plaintiffs in proposed privacy class actions should be given more say in who's picked as class counsel, in order to crack down on the "anemic settlements" that have resulted from the ineffective "old way of litigating" these matters, law firm Edelson PC argued in vying for lead counsel in a dispute over a data breach at genetics testing provider 23andMe.
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April 19, 2024
AI Health Data Co. Faces Investor Suit Over Accounting Issues
Atlanta-based health data platform company Sharecare and two of its executives face accusations that they failed to disclose certain accounting issues to investors, leading to stock price declines when the issues became public, according to a shareholder suit filed Friday in California federal court.
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April 19, 2024
Northshore Health Worker Drops Genetic Info Privacy Claims
A patient sitter for Northwestern HealthSystem has voluntarily dropped her proposed class suit claiming she and other workers were unlawfully required to give up information about their medical histories during the application process.
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April 18, 2024
Patient Data Breach Suit Should Be Tossed, Colo. Judge Says
A judge has recommended that CommonSpirit Health be allowed to escape a proposed class action in Colorado federal court accusing it of failing to secure healthcare data leading to a breach affecting more than 600,000 patients, saying the complaint fails to "allege an injury-in-fact."
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April 16, 2024
House Panel Takes Aim At Change Healthcare, FTC Over Hack
A House subcommittee exploring ways to boost cybersecurity in the healthcare industry on Tuesday blasted Change Healthcare for failing to take appropriate steps to block a damaging cyberattack that echoed another recent strike on critical infrastructure and the Federal Trade Commission for not stopping the provider from controlling such a large market share.
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April 16, 2024
Healthcare Industry Sees Spate Of New Data Sharing Suits
A $7 million-plus settlement between a federal regulator and a mental healthcare provider accused of improperly sharing patient data highlights the ubiquitous ties between health systems and tech giants like Facebook — and the growing legal and regulatory scrutiny over those relationships.
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April 12, 2024
Zoll Says 'Cookie-Cutter' Hack Claims Don't Show Harm
Zoll Medical Corp. is asking a Boston federal judge to toss a proposed class action brought by medical device customers whose personal information was released during a ransomware attack last year and an earlier data breach in 2019, arguing the consumers weren't actually injured.
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April 11, 2024
FTC Curtails Treatment Provider's Sharing Of Health Data
The Federal Trade Commission took its latest step Thursday to crack down on the mishandling of sensitive health information, announcing a settlement that requires a New York-based alcohol addiction treatment service to obtain affirmative consent before sharing this data with third parties and bars the company from disclosing this information for advertising purposes.
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April 11, 2024
Ernest Health Hit With Suit After Cybercriminal Data Breach
A group of former Ernest Health Inc. patients has hit the Texas-based hospital system with a proposed class action after a notorious group of cybercriminals breached the company's systems, saying that the company should've done more to protect patient data in a Thursday complaint.
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April 10, 2024
Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed
A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.
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April 09, 2024
Philips, Feds Enter Consent Decree Over Sleep Apnea Devices
Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.
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April 09, 2024
Predatory Medicare Marketing Faces Regulator Pushback
Consumers weighing Medicare plan options should have greater protections from predatory marketing and sales tactics, thanks to a new rule by the Centers for Medicare & Medicaid Services that was finalized April 4.
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April 08, 2024
Doctors Say MSU Vax Mandate Suit Needs High Court Review
Three doctors urged the U.S. Supreme Court to take up a case challenging Michigan State University's vaccine mandate after the Sixth Circuit backed the suit's dismissal, arguing that the circuit court should have applied a stricter standard when considering whether the government could interfere with patients' medical decisions.
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April 04, 2024
5th Circ. Scrutinizes Data-Tracking On La. Health Provider Site
A Fifth Circuit panel questioned Louisiana health care providers Thursday on the use of "tracking pixels" on their website, asking counsel for the providers whether a third party like Facebook could access patient records without patient permission.
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April 04, 2024
Microsoft Unit Gets Fed. Circ. Alice Win On Imaging Patents
The Federal Circuit on Thursday gave a win to a software company acquired by Microsoft for nearly $20 billion, affirming a decision that claims in four medical imaging patents it was accused of infringing are invalid for claiming only an abstract idea.
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April 04, 2024
Ga. OB-GYN Office Hit With Data Breach Class Action
An Atlanta OB-GYN practice has been hit with a class action in Georgia federal court over a January data breach that allegedly impacted the personal and protected health information of tens of thousands of patients.
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April 03, 2024
Microsoft Notches Fed. Circ. Win In 3D Imaging Patent Fight
The Federal Circuit on Wednesday backed a ruling from an administrative tribunal that wiped out most of a patent issued to a Florida radiologist and his ex-Lockheed Martin business partner, whose company is suing Microsoft over its line of HoloLens AR headsets.
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April 02, 2024
Mind Your Business: Wash. Privacy Law Ignites National Prep
Companies far beyond the borders of Washington are taking stock of what customer data they're collecting — and what it might reveal — as they face compliance with the state's expansive new privacy law.
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April 02, 2024
Healthcare Deals This Week: Moderna, Hildred And More
From a private equity fundraise worth hundreds of millions of dollars to a new life sciences IPO, the healthcare industry saw a handful of news-making deals this past week.
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April 02, 2024
Ga. Children's Hospital Accused Of Mining Patient Data
A major Georgia pediatric healthcare system has been using web data trackers to illegally transmit confidential patient data to Facebook and other companies to boost its bottom line, according to a proposed class action filed in the Peach State on Tuesday.
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March 29, 2024
4th Circ. Revives Data Breach Suit Against Medical Center
The Fourth Circuit on Friday revived a proposed class action alleging that Sandhills Medical Foundation Inc. failed to protect the personal information of patients whose data was leaked following a cyberattack, saying the health care provider is not shielded under federal immunity and that the government cannot be substituted as a defendant.
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March 28, 2024
White House Directs Agencies To Install AI Risk Safeguards
The White House on Thursday issued a new directive requiring all federal agencies to address safety and civil rights risks in their use and procurement of artificial intelligence in an array of settings, including conducting screenings at airports and making decisions affecting Americans' healthcare, employment and housing.
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March 26, 2024
Meet The Calif. Atty Taking On Health Insurers' Use Of AI
With the health insurance industry under scrutiny over its use of algorithms and artificial intelligence in the patient coverage review process, California appellate attorney Glenn Danas saw an opening for litigation with what he calls a "high outrage factor."
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March 26, 2024
Healthcare Hack May Be Wake-Up Call For Industry And Gov't
The recent cyberattack that sabotaged vital billing and prescribing services operated by a UnitedHealth unit that processes roughly half the medical claims in the U.S. has highlighted the urgent need for providers in this critical sector to not only understand supply chain security risks, but also to work more closely with the federal government to combat these threats.
Expert Analysis
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FTC's Health Privacy Actions Offer 5 Advertising Takeaways
The Federal Trade Commission's recent enforcement actions against GoodRx and BetterHelp highlight the need for any company engaging in common online advertising practices to pay close attention to the personal information they collect and share with third parties, say Kate Black and Sam Castic at Hintze Law.
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States Shouldn't Fear HIPAA When Improving Gov't Services
As the looming end of the COVID-19 public health emergency motivates states to streamline their processes for individuals seeking public benefits, they should generally not have to worry about violating the Health Insurance Portability and Accountability Act when sharing data across government services, says Jodi Daniel at Crowell & Moring.
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5 Data Privacy Practices Cos. Should Implement Now
Businesses that are not subject to a comprehensive data privacy law should nevertheless consider implementing privacy practices that are consistent with current norms to help mitigate both common law exposure and an expensive rush to compliance if a federal law is passed, say John Rolecki and Alexander Thibodeau at Varnum.
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Privacy Lessons From FTC's BetterHelp Consent Decree
The Federal Trade Commission's recent enforcement action against BetterHelp highlights the growing risk associated with the use of third-party cookies and pixels on websites for companies that offer health services, say Rachel Marmor and Shannon Hartsfield at Holland & Knight.
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118th Congress: Investigative Priorities And Rule Changes
Attorneys at Gibson Dunn lay out what companies and individuals can expect with regard to congressional investigations in the 118th Congress, from political priorities to new rules and authorities.
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Emerging Trends In Electronic Health Record Enforcement
As electronic health record systems become increasingly ubiquitous in health care, recent Anti-Kickback Statute and False Claims Act cases involving EHR systems provide a helpful list of issues that tech-savvy relators and government investigators might identify, say Ellen London at London & Stout and former Assistant U.S. Attorney Li Yu.
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FTC's GoodRx Action Highlights Risks For Digital Health Cos.
The Federal Trade Commission's first-of-its-kind enforcement action against GoodRx for unlawfully sharing sensitive customer information is indicative of regulators' growing interest in the digital health space and heightens the importance of taking proactive compliance steps, say attorneys at Ropes & Gray.
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What DOJ's 2022 Recovery Stats Say About FCA Enforcement
Despite showing a decline in False Claims Act recoveries in fiscal year 2022, the U.S. Department of Justice's recently released statistics should lead companies to expect a continued rise in government-initiated investigations, pandemic-related fraud enforcement and FCA cases involving new technology, say attorneys at Crowell & Moring.
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Medicare Developments Ahead For Remote Health Monitoring
Stakeholders interested in remote monitoring services should keep an eye on an upcoming multijurisdictional contractor advisory committee meeting that may lead to a new local coverage determination affecting Medicare coverage for remote monitoring devices, say attorneys at McDermott.
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Calif. Privacy Law Holds Implications For Mental Health Apps
California is leading the way in privacy regulation with its amended Confidentiality of Medical Information Act, which has important compliance repercussions for mental health app developers and could serve as a model for similar laws in other states, say Christine Moundas and Elana Bengualid at Ropes & Gray.
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New Clinical Trial Law Promotes Diversity And Modernization
The Food and Drug Omnibus Reform Act, signed into law last month, will likely encourage more equitable subject recruitment and enrollment in clinical trials, and also could create a pathway toward clarifying ambiguities that have historically been left for regulated entities to piece together, say attorneys at Ropes & Gray.
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Evaluating The Legal Ethics Of A ChatGPT-Authored Motion
Aimee Furness and Sam Mallick at Haynes Boone asked ChatGPT to draft a motion to dismiss, and then scrutinized the resulting work product in light of attorneys' ethical and professional responsibility obligations.
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2022 Law And Policy Highlights In Digital Health Care
This year, federal regulators made good on several commitments to create new opportunities for digital health innovators, and a number of promising cybersecurity bills are on the horizon, but not all virtual health care law and policy developments have been positive, say attorneys at Arnold & Porter.