Digital Health & Technology
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January 19, 2024
Colo. Group Seeks Damage Caps Drop, Reporting Expansion
An issue committee, supported in part by the Colorado Trial Lawyers Association, has launched an effort to place two statewide initiatives before Colorado voters in November, designed to help patients and those filing suits over catastrophic injuries and wrongful deaths.
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January 19, 2024
Becton Investors Get Initial OK Of $85M Deal Over Recall
A magistrate judge granted preliminary approval to an $85 million settlement a class of Becton Dickinson investors reached with the medical tech company over securities fraud claims that it hid regulatory problems regarding sales of its Alaris infusion pump, which Becton recalled in 2020.
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January 19, 2024
WHO Report Examines Pros And Cons Of AI In Healthcare
The World Health Organization has released new guidance on opportunities and ethical risks presented by introducing generative artificial intelligence models such as ChatGPT into the healthcare sector.
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January 19, 2024
Fla. Medical Device Co. Sued Over Data Breach That Hit 54,000
A Tampa-based medical device company has been sued over a data breach that allegedly compromised the personal information of 54,000 people, with a proposed federal class action alleging that the company was negligent in protecting its customers' private data.
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January 18, 2024
FTC Asked To Force Google To Delete Sensitive Location Data
Google hasn't kept its promise to delete sensitive location data, including records of users' visits to abortion clinics and addiction centers, a pair of tech advocacy groups told the Federal Trade Commission on Thursday, urging the commission to hit Google with penalties and block its "unlawful" data practices.
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January 18, 2024
CMS Announces State-Based Behavioral Health Model
The Centers for Medicare & Medicaid Services on Thursday launched a program it said will fund up to eight states to implement a new value-based care model designed to improve health outcomes for vulnerable populations.
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January 18, 2024
FDA And CMS Leaders Unite Over Proposed Lab Test Rule
Leaders at the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services joined forces on Thursday, stressing that the two agencies are on the same page regarding the FDA providing increased oversight of laboratory developed tests, or LDTs.
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January 18, 2024
Midwest Healthcare Group Escapes Bulk Of Data Breach Suit
An Illinois federal judge tossed most of a proposed class action alleging an anti-poverty nonprofit's careless management of clients' personal information, including sensitive health information, resulted in a data breach.
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January 17, 2024
Apple Drops Blood Oxygen Tech From New Watches After Ban
After the Federal Circuit ruled Wednesday that Apple can't import Apple Watches that include a blood oxygen sensor found to infringe two Masimo patents, Apple said the feature will be dropped from its flagship watch models sold beginning Thursday.
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January 16, 2024
Hospital Groups Nationwide Slam Online Tracking Restrictions
Federal guidance restricting the use of online tracking technology in healthcare has disrupted the ability of hospitals to reach underserved communities and connect the public with accurate medical information, 17 state hospital associations told a federal court.
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January 16, 2024
Crowell Adds Moses Singer Health Trio In New NYC Office
Crowell & Moring LLP announced Tuesday that it has hired a team from Moses & Singer LLP with rare expertise in regulatory and compliance issues related to clinical trials for biotech and health tech companies.
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January 15, 2024
Apple Cleared To Avoid Import Ban With Redesigned Watch
U.S. Customs and Border Protection has found that redesigned versions of the Apple Watch without a blood oxygen monitor are not subject to an import ban in a patent dispute with Masimo, according to a Monday court filing by Masimo.
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January 12, 2024
Healthcare Co. HealthEC Hit With Data Breach Suit
Healthcare software company HealthEC has been hit with a lawsuit alleging that a July 2023 data breach affected nearly 4.5 million patients and that the company failed to comply with Federal Trade Commission guidelines and industry standards.
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January 12, 2024
Lab Says COVID-19 Test-Maker Owes $30M Over Faulty Kits
A California-based manufacturer of COVID-19 testing kits has been hit with a $30 million suit alleging it sent defective tests to an independent clinical lab, causing the lab to receive false positive results and subsequently get banned from testing sites.
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January 11, 2024
Quest Fertility Biz Reaches $1.25M Deal In Data Breach Case
A Quest Diagnostics fertility treatment unit has reached a $1.25 million settlement, according to a Wednesday filing in Massachusetts federal court, after a 2021 ransomware attack and accusations that a slow response by Quest left sensitive information unguarded.
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January 11, 2024
Electronic Waveform Says Travelers Owes It $1.3M
A Minnesota medical device manufacturer has told a federal court that insurer Travelers has been intentionally down-coding a pain management device popular among professional athletes in order to underpay the company, resulting in a loss of $1.3 million.
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January 11, 2024
FCC Issues Final Rule On Rural Telehealth Discount
The Federal Communications Commission on Wednesday issued an update to the Rural Health Care program, changing it to allow healthcare providers with conditional eligibility to request funding and compete for bidding.
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January 11, 2024
Conn. Healthcare Co. Eyes Deal For Data Breach Class
Merritt Healthcare Advisors is working to finalize a settlement with a proposed class of consumers who claim that the company's lax security allowed cybercriminals to access their personal information, according to a paperless order entered Thursday in the District of Connecticut.
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January 10, 2024
Rex Medical Asks Fed. Circ. To Decry Slashing Of $10M Award
Rex Medical LP is asserting to the Federal Circuit that a Delaware federal judge was wrong to slash a jury's $10 million patent damages verdict in Rex's favor to just $1 over a purported lack of evidence.
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January 10, 2024
FDA 'Can't Do This Alone,' Wants Help Vetting AI In Healthcare
The Food and Drug Administration will almost certainly need outside help regulating the safety of artificial intelligence deployed by hospitals and healthcare organizations, the agency's commissioner said Wednesday, citing the complexity of the technology and need to track health outcomes over long periods of time.
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January 09, 2024
FDA Digital Tech Rule Faces Health Privacy, Inequity Test
A new federal road map for collecting "remote" health data in clinical investigations could help speed such technologies to the marketplace, experts told Law360, while creating new risks to patient privacy and the effort to address inequities in healthcare.
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January 09, 2024
FTC Halts Data Broker's Location Data Sharing In Novel Deal
The Federal Trade Commission has stepped up its efforts to curtail the unauthorized disclosure of consumers' sensitive location information, announcing a groundbreaking settlement Tuesday with a data broker that the agency claims unlawfully sold precise location data that could be used to track people to reproductive health clinics, religious worship centers and other sensitive places.
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January 09, 2024
Mich. Resident Sues Software Co., Provider Over Data Breach
A Michigan resident is asking a federal court to impose damages on software company Welltok LLC and Michigan provider Corewell Health East after the health information of a million patients in its database became the target of a ransomware attack.
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January 08, 2024
Orrick Client Delta Dental Of Calif. Hit With Data Breach Suit
Weeks after Delta Dental of California's law firm Orrick Herrington & Sutcliffe LLP was hit with a proposed class action over a data leak that allegedly included Delta files, the insurer was hit with a suit in Massachusetts federal court on Monday over another leak connected to the massive MOVEit data breach.
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January 08, 2024
Wash. Pediatric Hospital Asks Judge To Toss Data Privacy Suit
Seattle Children's Hospital has urged a state judge to dismiss a proposed class action alleging the hospital violated Washington privacy and consumer laws, contending the plaintiffs' own actions were to blame if any personal information was shared with Meta, the parent company of Facebook.
Expert Analysis
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Ransomware Payment Lessons Amid DOJ Recovery Success
The U.S. Department of Justice’s recent successes clawing back ransom payments made to hacking groups provide companies an additional factor to consider when deciding whether to engage with law enforcement after experiencing a breach, whether to pay a ransom demand, and whether to try to recover the payment, says Tyler Bridegan at Wiley.
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What's Next For DOJ's COVID Enforcement In Health Care
As we enter the end of the third year of the pandemic, a few fraud-related trends and risks have emerged, necessitating important steps that health care and life sciences companies should take in light of continuing U.S. Department of Justice scrutiny, say attorneys at Arnold & Porter.
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How To Minimize Risk When Launching Smart Medical Devices
Prior to launching a smart medical device, there are several critical steps that companies can take in order to protect their intellectual property, get approval from the U.S. Food and Drug Administration and ensure the safety of their data, say attorneys at Crowell & Moring.
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Health Issues To Watch In Inflation Act, Other Policy Initiatives
The newly signed Inflation Reduction Act includes a number of significant drug pricing reforms, and the future holds a wider array of health issues that may be addressed in pending legislation when Congress returns in September, says Miranda Franco at Holland & Knight.
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DOJ Filing Reawakens Fraud-On-The-FDA Theory Of Liability
The U.S. Department of Justice’s recent statement of interest in U.S. ex rel. Crocano v. Trividia Health before a Florida federal court represents a substantial attempt to revive a False Claims Act liability theory involving misstatements to the U.S. Food and Drug Administration, potentially leading to increased scrutiny of medical products, say attorneys at Duane Morris.
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Digital Health Cos. Should Expect More Scrutiny Amid Growth
As the digital health market continues to flourish, the privacy and security of patient data has become a focus of legislative, regulatory and interest group action, and developers should be motivated to reassure both regulators and consumers that users' data is adequately protected, say attorneys at Kirkland.
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Anti-Kickback Circuit Split Holds Implications For Defendants
The Eighth Circuit's recent decision in U.S. v. D.S. Medical represents a significant step toward holding plaintiffs to more exacting burdens of proof in Anti-Kickback Statute False Claims Act suits, and the outcome of the resulting circuit split could decrease estimated damages for defendants, say attorneys at Gibson Dunn.
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Post-Dobbs HHS Guidance Brings Privacy Considerations
The U.S. Supreme Court's recent decision in Dobbs v. Jackson Women's Health Organization, and ensuing guidance from the U.S. Department of Health and Human Services, will create new privacy compliance issues for health care providers and other companies collecting personal information concerning the use of reproductive health services, say attorneys at Ropes & Gray.
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HHS Fraud Alert Is A Major Warning To Telehealth Industry
The U.S. Department of Health and Human Services recently issued a rare fraud alert, indicating potential changes in telemedicine enforcement, and suggesting that digital health entities are likely to face subpoenas, civil investigative demands and other inquiries, say attorneys at Hooper Lundy.
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FDA Medical Device Cyber Guidance Protects Patients, Cos.
By carefully following the U.S. Food and Drug Administration regulations on cybersecurity for medical devices — including its latest guidance on premarket submissions — and anticipating, tracking and fixing vulnerabilities, manufacturers can reduce risks to patients, as well as their own risks of product liability and data breach claims, say attorneys at Dechert.
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The State Of Digital Health Care's Pandemic Transformation
Two years into the COVID-19 pandemic, tech companies are helping to drive the health industry's transition into a new era of greatly expanded digital health and remote care, though some new challenges involving system compatibility and cybersecurity have arisen as well, says Carter Gage at Sheppard Mullin.
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Readying Cybersecurity Protocols For The Quantum Age
As there is a significant likelihood that quantum computers will be able to break the majority of current encryption methods within the next decade, organizations should make preparations now to transition to post-quantum security mechanisms, says Ryan McKenney at Orrick.
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2 FCA Settlements Highlight Gov't Cyber Liability Focus
Recent False Claims Act settlements with Comprehensive Health Care Services and Aerojet Rocketyne illustrate government contractors' growing cybersecurity liability, and underscore how important it is for companies to comply with new incident reporting regulations and live up to standing contractual obligations, say attorneys at O'Melveny.