Digital Health & Technology

  • 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.

  • 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.

  • 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. 

  • 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.

  • 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.

  • 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. 

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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. 

  • 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.

  • 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.  

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • January 26, 2024

    Bills Aim To Halt Cash To Chinese Cos. Over Genetic Data

    Lawmakers on Capitol Hill have introduced legislation to block Chinese biotech companies from receiving federal funding if they have ties to the Chinese Communist Party, saying the goal is to prevent such companies and the party from stealing America's genetic data.

Expert Analysis

  • 2 FCA Settlements Highlight Gov't Cyber Liability Focus

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    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.

  • What CMS E-Records Proposal Means For Hospitals

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    The Centers for Medicare & Medicaid Services has proposed significant changes to the Medicare Promoting Interoperability Program — including increasing transparency through public reporting and requiring history queries of prescription drug monitoring programs — that will have far-reaching ramifications for participating hospitals, say Christine Moundas and Gideon Palte at Ropes & Gray.

  • How To Protect Health Care Trade Secrets With Covenants

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    Post-employment restrictive covenants such as noncompetes are an effective way for health companies to protect confidential information and trade secrets, but employers must be cognizant of the rapidly changing state laws governing the enforceability of such agreements, say Erik Weibust and Katherine Rigby at Epstein Becker.

  • HSR Statistics Show Increasing Scrutiny Of Health Care M&A

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    Recent enforcement and Hart-Scott-Rodino statistics illustrate the Federal Trade Commission's growing interest in the application of federal antitrust law to health care transactions and the FTC's ability to test novel theories of harm in this area, say Amanda Wait and Vic Domen at Norton Rose.

  • New Ariz. Cyberattack Info Sharing May Be Worth The Burden

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    A recent amendment to Arizona’s data breach notification law, and similar state and federal cyber incident reporting rules, significantly burden companies that are attacked, but increased information sharing could help prevent and mitigate the damage from future data security incidents, say Christine Czuprynski and Kate Jarrett at McDonald Hopkins.

  • Ransomware Risks For Health Cos. And How To Avoid Them

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    As the health care industry is a particularly valuable and vulnerable target of ransomware attacks, it's important for companies to understand possible attack methodologies and best steps for mitigating risks, says Nathan Kottkamp at Williams Mullen.

  • What FDA Expects From Medical Device Cybersecurity Efforts

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    The U.S. Food and Drug Administration's latest draft guidance on cybersecurity for medical devices highlights the distinction between safeguards that are "built in" rather than "bolted on," emphasizing the importance of robust design controls, say Jae Kim and Raymond Williams at DLA Piper.

  • As Cyber Risks Surge, Remember Attorneys' Ethical Duties

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    The prevalence of remote work and a greater threat of Russian cyberattacks should serve as a stark reminder of a lawyer's professional obligations to guard against unauthorized disclosure of client information and to protect client interests in the event of a cyberattack, says Alvin Mathews at Ulmer & Berne.

  • Seeking Clarity On Medical Privacy In Fla. Class Actions

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    When class actions are filed in Florida courts against medical service providers, even over issues other than medical treatment, and plaintiffs seek the names of other possible class members, the federal health privacy law and Florida's right to privacy are implicated — but the issue has yet to receive sufficient attention from the courts, says Aaron Weiss at Carlton Fields.

  • Navigating Ambiguities In New Cyber Reporting Law

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    The recently passed Cyber Incident Reporting for Critical Infrastructure Act requires increased cybersecurity defense and response disclosures, but owners and operators should take the law's lack of clarity on certain parameters into account as they prepare to comply, say attorneys at Holland & Knight.

  • Preparing For New Mandatory Cyber Reporting Rules

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    The requirements of a new federal law mandating cyber incident reporting for critical infrastructure will not become operational for several months, but affected companies should begin assessing whether their response plans incorporate critical policies and procedures to ensure compliance, say Steven Stransky at Thompson Hine and Lacy Rex at Oswald Companies.

  • 5 Steps For Counsel Managing Health Care Data Breaches

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    Considering the growing threat of data breaches and particular risks to health care providers and related companies, it is critical for counsel to take adequate steps to mitigate harm to patients, protect critical data, improve systems and navigate government investigations in the aftermath of a data security incident, say attorneys at K&L Gates.

  • Addressing Patient Requests For Unauthorized Treatment

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    Recent controversy over patient requests for ivermectin as COVID-19 treatment highlights the complex conversations and tricky compliance challenges that health providers must sometimes navigate when patients request nonstandard treatments, say John Dow, Kathleen Hogan and Catherine Adams at St. Peter’s Health Partners.