Digital Health & Technology

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • January 08, 2024

    Eli Lilly, Novartis Could Pump Close To $3B Into AI Drug Tech

    Eli Lilly & Co. and Novartis could invest close to $3 billion in the development of artificial intelligence for drug discovery under two new agreements with a digital biology company owned by Google's parent company.

  • January 05, 2024

    Hospitals Want Fast End To 'Flawed' Online Tracking Rules

    The American Hospital Association and others on Friday urged a Texas federal court to scrap federal guidance effectively barring certain healthcare entities from using online tracking technology as the data captured from visitors to their websites falls "far outside" the information protected by federal health privacy law. 

Expert Analysis

  • NY Data Breach Penalty Expands Regulatory Requirements

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    The New York Department of Financial Services’ recent consent order with EyeMed is an aggressive reading of state regulation that arguably expands current requirements, which could increase the complexity of the risk assessment process and may serve as a precedent for other privacy and data security regulators, says Rick Borden at Frankfurt Kurnit.

  • Cybersecurity Expectations Intensify For Medical Device Cos.

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    A recent FBI industry notification and U.S. Food and Drug Administration draft guidance highlight urgent compliance considerations for medical device manufacturers, and contrasts with how federal regulators have previously treated health care players as victims in cybersecurity incidents, say attorneys at Morrison Foerster.

  • Risk Mitigation In Face Of Rising Legal Malpractice Claims

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    As the recent rise in frequency and cost of legal malpractice claims is expected to continue amid global high inflation and economic uncertainty, law firms and insurers would be wise to evaluate key risk areas and consider six steps to minimize exposure, say Nicole Shapiro and Cory Stumpf at Atheria Law.

  • Unpacking FDA's Final Clinical Decision Support Guidance

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    The U.S. Food and Drug Administration's latest guidance on clinical decision support software introduces new concepts, questions and ambiguities, and may be challenging to implement in practice, say attorneys at Covington.

  • How Cos. Can Adapt To Global AI Regulation Trends

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    Companies can prepare for the future of artificial intelligence regulation by monitoring proposed and existing regulations both in the U.S. and abroad, tailoring their internal compliance architecture for AI-specific risks, and looking for opportunities to lead on governance issues, says Nicholas Diamond at Jackson Walker.

  • 4 Strategies For Drafting Effective Consumer Breach Notices

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    Businesses should consider key strategies when drafting consumer breach notification letters, such as knowing their audience and what is on their mind, and prioritizing user-friendliness and tone, say attorneys at Troutman Pepper.

  • How Contractors Can Avoid Cybersecurity FCA Violations

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    Recent U.S. Department of Justice settlements and remarks underscore heightened focus on cybersecurity liability under the False Claims Act, so government contractors should consider compliance measures such as conducting periodic risk assessments, being responsive to employee concerns, and more, say attorneys at WilmerHale.

  • EU Regulation Highlights AI Issues For Digital Health Cos.

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    As the regulation of artificial intelligence is high on the agenda for EU and U.K. policymakers and regulators, and likely imminent in the U.S., now is the time for providers in the digital health space to consider how compliance may need to change, and safeguard their position in the market, say Chris Eastham and Olivia Morgan at Fieldfisher.

  • What DOJ Enforcement Shift Means For Life Sciences Cos.

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    Though monitoring life science company compliance has historically been the domain of the U.S. Department of Health and Human Services, recent trends suggest that the U.S. Department of Justice may be assuming a primary role going forward, raising interesting questions for the industry, say attorneys at Skadden.

  • Ransomware Payment Lessons Amid DOJ Recovery Success

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    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.

  • What's Next For DOJ's COVID Enforcement In Health Care

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    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.

  • How To Minimize Risk When Launching Smart Medical Devices

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    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.

  • Health Issues To Watch In Inflation Act, Other Policy Initiatives

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    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.