Digital Health & Technology
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June 27, 2024
Fla. Gov. Vetoes Bill Giving Immunity On Data Breach Claims
Florida Gov. Ron DeSantis on Wednesday vetoed a bill that would have provided immunity from data breach lawsuits for businesses that complied with certain cybersecurity standards, citing concerns that the legislation could result in Floridians' data being less secure.
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June 27, 2024
High Court Allows Idaho Emergency Abortions, For Now
The U.S. Supreme Court on Thursday allowed abortions in Idaho to continue in emergency situations under a federal law requiring doctors at Medicare-funded hospitals to provide emergency care, including abortions.
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June 26, 2024
State Data Privacy Law Patchwork: Midyear Report
States jumped on the consumer data privacy law bandwagon at a brisk clip in the first half of 2024, although it remains unclear if this push will be enough to encourage Congress to finally enact a nationwide framework this year.
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June 26, 2024
Apple Watch Improvement Is 'Inferior,' Docs Tell 9th Circ.
Four cardiac specialists backed medical monitoring startup AliveCor against Apple in a Ninth Circuit amicus brief Tuesday arguing a district court wrongly nixed antitrust claims by crediting the phaseout of a heart rate monitoring algorithm as an improvement when all it did was deny patient access to "potentially life-saving" technology.
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June 25, 2024
Judge Likely To Block Medical Record Co.'s Anti-Bot CAPTCHAs
A Maryland federal judge appeared ready to enjoin electronic medical records company PointClickCare from restricting nursing home analytics company Real Time Medical Systems' automated access to its online repositories Tuesday, potentially taking an early crack at defining the 21st Century Cures Act's data sharing provisions.
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June 24, 2024
$2.9M Health Co. Data Breach Settlement Gets Final Approval
A Michigan federal judge has given final approval to a $2.9 million deal for a maker of prosthetics and orthotics to settle claims the company didn't protect customers' sensitive information from a cyberattack.
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June 20, 2024
Web-Tracking Guidance Exceeded HHS' Authority, Judge Says
A Texas federal judge ordered the Biden administration Thursday to rescind its new guidance restricting hospitals' use of online tracking technology, declaring that federal officials had overstepped their authority by redefining what they consider protected health information.
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June 18, 2024
Novant Pays $6.7M For Sharing Patient Data With Facebook
A North Carolina federal judge on Monday gave the final seal of approval to a proposed $6.7 million deal resolving litigation alleging Novant Health Inc. shared sensitive patient data with Facebook, certifying a nationwide settlement class of roughly 1.3 million individuals.
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June 18, 2024
COVID Test Maker Can't Shake All Of $30M Faulty Kit Suit
A New Jersey federal judge won't let California-based laboratory equipment maker Atila Biosystems Inc. out of a suit alleging it sold faulty COVID-19 testing kits, saying Fusion Diagnostic Laboratories LLC has adequately pled a breach of contract claim.
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June 18, 2024
Gene Therapy Co. Taps Experienced Bioscience Legal Chief
Kriya Therapeutics Inc., which develops gene therapies to address common diseases, said Tuesday it has chosen a veteran bioscience general counsel to be its chief legal officer.
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June 17, 2024
Calif. Becomes Last State To Ink Deal Over Blackbaud Breach
Blackbaud Inc. has agreed to pay $6.75 million to resolve data security claims brought by California's attorney general, who was the only one to sit out a nearly $50 million settlement that the software provider reached last year with every other state over a 2020 ransomware attack that affected thousands of its customers.
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June 17, 2024
Ex-Stimwave CEO Gets 6 Years For Dummy Implant Scheme
The founder and former CEO of Stimwave Technologies was sentenced to six years in prison Monday after tearfully proclaiming her innocence to healthcare fraud charges, with a Manhattan federal judge saying it's "sad" the defendant doesn't recognize the harm she inflicted by selling nonfunctional pain management device components.
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June 13, 2024
IP Forecast: Cooley Atty Faces DQ Bid Over Past Patent Work
A prominent Cooley LLP lawyer will face questions next week in a Philadelphia courtroom over her work a decade ago at her former firm defending a cloud software startup that is now suing a Cooley client. Here's a spotlight on that case — plus all the other major intellectual property matters on deck in the coming week.
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June 10, 2024
5 Teva Inhaler Patents Kicked Out Of Orange Book
A New Jersey federal judge said Monday that a handful of patents covering Teva-brand asthma inhalers were "improperly listed in the Orange Book," a legal holding that U.S. Federal Trade Commission Chair Lina Khan quickly took some credit for.
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June 10, 2024
Rehab Clinics Add To MultiPlan Insurance Fixing Pile-On
Addiction treatment providers sued MultiPlan, Aetna, Cigna, UnitedHealth and Elevance Friday and Saturday in 14 separate New York federal court complaints that appear to be the first to add substance abuse disorder-specific allegations to the cases pegging MultiPlan at the center of a scheme to suppress insurer payouts.
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June 10, 2024
Health Data Co. Says Rival's Request Risks Patient Security
A healthcare data company pushed back against claims in Maryland federal court that it blocks a rival's access to nursing home patient data used to identify potential complications, saying the rival is asking to disable security measures that prevent attacks on its system.
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June 10, 2024
Medical-Aesthetic Device Rivals Set For Sept. Poaching Trial
A Boston federal judge on Monday scheduled a post-Labor Day jury trial for medical-aesthetic device company Cynosure's $78 million poaching lawsuit against rival Reveal Lasers, urging the parties to streamline their exhibits and damages claims.
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June 07, 2024
DC Circ. Undoes Library Of Congress Win In Fair Use Fight
The D.C. Circuit on Friday reversed a lower court's decision that had rejected two industry groups' challenge to a final rule that categorized medical device diagnostic procedures and repairs as fair use exemptions to U.S. copyright law.
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July 03, 2024
The State Of The Retail Industry's Healthcare Investments
Amazon and Walgreens separately announced changes to their healthcare offerings, revealing the growing divide between retail companies as they grapple with a complicated business. Law360 Healthcare Authority looks at major retailers' recent healthcare ventures and where they stand now.
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June 04, 2024
Medical Board Group Keeps AI Liability Focus On Doctors
When emergency room nurses and doctors make split-second decisions using an artificial intelligence tool, who ultimately bears responsibility if a patient winds up harmed? Recent guidance from the Federation of State Medical Boards keeps the onus squarely on doctors.
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May 31, 2024
Samsung Strikes First With Smart Ring IP Suit Against Oura
Samsung has yet to announce a release date for its new Galaxy Ring brand of wearable, health-tracking devices, but it has filed an intellectual property suit in California federal court Thursday targeting a Finnish startup that makes its own line of smart rings.
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May 30, 2024
FTC, SEC Urged To Probe UnitedHealth's 'Negligent' Security
The chair of the U.S. Senate finance committee on Thursday pressed the Federal Trade Commission and the U.S. Securities and Exchange Commission to hold UnitedHealth Group and its top executives liable for "numerous" cybersecurity failings that fueled a debilitating cyberattack on its Change Healthcare unit.
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May 30, 2024
Veradigm Execs Sued Over Company's Nasdaq Delisting
Current and former members of healthcare technology company Veradigm Inc.'s top brass were sued in Illinois federal court by shareholders alleging that the company suffered stock drops following a string of financial reporting blunders starting in 2021, which caused it to overstate roughly $40 million in revenue before facing a delisting notice from Nasdaq.
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May 29, 2024
Greenberg Traurig Adds IP Atty From Eversheds Sutherland
Greenberg Traurig LLP has bolstered its California bench of attorneys with an Eversheds Sutherland lawyer who has years of experience advising digital health and medical device companies on intellectual property issues.
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May 28, 2024
Pharmacy Benefits Co. Taps Health Atty To Lead Legal Team
RxBenefits, a company focused on generating savings for employers providing pharmacy benefits, has appointed a new chief legal officer to oversee its legal and regulatory compliance efforts.
Expert Analysis
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New Considerations In Med Device Cybersecurity Compliance
Recent guidance from the U.S. Food and Drug Administration clarifies premarket submission procedures related to medical device cybersecurity, and indicates a significant expansion in the agency's expectations surrounding risk management practices for both manufacturers and providers, says Meghna Parikh at Buchalter.
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Federal Oversight Of AI In Healthcare Is Taking Shape
A recent proposed rule from the U.S. Department of Health and Human Services provides early insights into how the federal government intends to oversee artificial intelligence and machine learning in healthcare, highlighting priorities like transparency, equity and potential kickback implications, say attorneys at Hooper Lundy.
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A Close Look At Pennsylvania's Data Breach Law Changes
New amendments to Pennsylvania's Breach of Personal Information Notification Act will hold state agencies to stricter notification requirements more in line with those in other states, and will allow entities to determine a breach has occurred before their notification obligations take effect, says Lauren Godfrey at Constangy.
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Abortion Pill Rulings Will Hinder FDA Authority
Although the Fifth Circuit recently stayed a Texas federal court's ruling that invalidated the U.S. Food and Drug Administration's approval of a commonly used abortion medication, several points made by the courts are worth considering for their potentially chilling effect on FDA authority and the challenges they may create for the life sciences industry, say attorneys at Morgan Lewis.
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Key Guidelines For Conducting Clinical Trials Overseas
Excerpt from Practical Guidance
Conducting clinical trials outside the U.S. offers many benefits to researchers, but these benefits come with countervailing ethical and legal challenges that must be carefully addressed, say attorneys at Bass Berry.
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Recent Growth Factors Driving Life Sciences Transactions
In view of challenges posed by last year's economic downturn, life sciences companies have increasingly turned to collaboration and licensing arrangements, with a focus on deal activity in artificial intelligence, digital health and gene therapy, say attorneys at Ropes & Gray.
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How Cannabis Cos. Can Keep Up With Privacy Compliance
With the cannabis industry's rapid growth and access to sensitive consumer information, and the ever-changing patchwork of state data privacy laws, it is becoming increasingly important for marijuana businesses to treat cybersecurity as a significant risk and management priority, say attorneys at Goodwin.
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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.