Digital Health & Technology
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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."
-
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.
-
March 25, 2024
Ga. Judge Slams Attys Over 'Incredible' House Arrest Request
A Georgia federal judge on Monday postponed the sentencing of a cybersecurity contractor convicted of hacking into a hospital's computer systems after tearing into his attorneys over their request for nearly five years of home confinement instead of prison, for which the judge found "no basis."
-
March 22, 2024
$900M Trade Secrets Case Against Kaiser Foundation Flops
A California state judge has ruled that, after more than five years of litigation against the Kaiser Foundation, a pastor's small medical technology startup cannot "explain what was unique or secret about its conception for transmitting patient data" that was purportedly worth beyond $900 million.
-
March 22, 2024
Final OK Sought For Economic Loss Deal In CPAP Recall MDL
Users of Philips' recalled CPAP breathing machines have asked a Pennsylvania federal judge to give her final OK to their $467.5 million settlement with the company to cover economic loss claims, arguing only a few objections to the deal remain.
-
March 22, 2024
LifeCell Cleared Of Liability In NJ Strattice Hernia Mesh Trial
New Jersey state jurors on Friday cleared LifeCell of liability in a Kentucky woman's suit alleging the design of its Strattice surgical mesh is defective and caused a hernia to reoccur and ultimately resulted in "life-altering" surgery, giving the medical device company the first win in a venue with at least 93 pending cases with tort claims over the mesh.
-
March 21, 2024
Colo. Distributor Seeks $2.3M Sanction For Stryker Spoilation
A Colorado medical device distributor urged a federal judge to make Stryker and its lawyers pay $2.3 million in attorney fees as sanctions for "pervasive misconduct" throughout discovery and trial, arguing discovery violations will otherwise become the "cost of doing business" for the medical technology giant.
-
March 21, 2024
UpHealth Claims $110M Win In Glocal Control Fight
Global digital health company UpHealth Inc. says an arbitral panel has awarded it more than $110 million following a dispute that arose out of its subsidiary's acquisition of Glocal Healthcare Systems in 2020 — even as Glocal decried the award as "one-sided and perverse."
Expert Analysis
-
Why Privacy And Trade Secret Law Are On A Collision Course
The conflict between the legal regimes of trade secret law and data privacy law is growing as companies increasingly collect and use data about their customers, making it key for organizations to find ways to comply with both laws in order to protect their intellectual property and the privacy of their customer, says Jenny Colgate at Rothwell Figg.
-
Negotiating AI-Life Sciences Partnerships To Minimize IP Risk
When life sciences companies and AI companies form partnerships to foster innovation, the parties should align interests as well as mitigate intellectual property risks by strategically identifying and addressing the unique AI-related legal issues, such as training data, AI model and output, say attorneys at Finnegan.
-
Parsing Through The FTC's Proposed Health Privacy Updates
The Federal Trade Commission's recently proposed updates to its Health Breach Notification Rule contain subtle but significant changes to key terms that help modernize the agency's health app regulation and provide stakeholders an important opportunity to help shape the future of virtual health care, say attorneys at Arnold & Porter.
-
Regulating AI: An Overview Of Federal Efforts
The U.S. has been carefully managing a national policy and regulatory ecosystem toward artificial intelligence, but as AI technology continues to expand into our everyday lives, so too has its risks and the need for regulation, says Jennifer Maisel at Rothwell Figg.
-
Compliance Takeaways From HHS Information Blocking Rule
A recently finalized rule from the U.S. Department of Health and Human Services' Office of Inspector General demonstrates a renewed focus on investigating practices that may interfere with patients' access to their electronic health information, and should encourage renewed compliance efforts across a range of processes, say attorneys at Ropes & Gray.
-
Life Sci Cos. Should Work With FDA To Shape AI Regulation
Due to the rapidly evolving nature of potentially long-term regulatory paradigms for artificial intelligence, drug and biologic manufacturers looking to leverage AI should engage strategically with the U.S. Food and Drug Administration to ensure clarity surrounding compliance obligations, say Lowell Zeta and Blake Wilson at Hogan Lovells.
-
BIPA, Meta Pixel Suits Could Reshape Cybersecurity Litigation
Businesses and attorneys should watch several pending electronic privacy cases that revolve around disclosure of protected personal information and health data, which may shape how courts handle damages and class actions in the future of cybersecurity litigation, say Kelly Johnson and Melanie Condon at Goldberg Segalla.
-
The Double-Edged Sword Of Using ChatGPT In Health Care
While ChatGPT has shown promising potential in health care, one of the key challenges for players in this space is balancing patient privacy and data protection with the benefits of utilizing this technology, say attorneys at Sheppard Mullin.
-
Addressing Legal Issues Raised By AI Use In Health Care
Excerpt from Practical Guidance
With the usage of artificial intelligence and machine learning in health care likely to be governed by a patchwork of state laws for the near future, industry actors should build flexibility into products to meet evolving regulatory concerns, including monetization of patient data and professional licensing questions, say Sara Shanti and Phil Kim at Sheppard Mullin.
-
New Health Data Compliance Considerations For Pa. Lawyers
Given the regularity with which attorneys handle private health information, it is important for Pennsylvania firms to understand recent significant amendments to the state's data breach law, which address information not currently covered by federal law, says Mark Mattioli at Post & Schell.
-
Mitigating Risks Of Developing Drugs And Devices With AI
As the use of artificial intelligence in drug and medical device development advances, companies should implement five key steps to identify and mitigate areas of potential risk before regulatory frameworks catch up, say attorneys at King & Spalding.
-
Scope Of FTC's Health Info Enforcement May Expand
The Federal Trade Commission's proposed amendments to the Health Breach Notification Rule signal the agency's mounting efforts to regulate consumer health information beyond the reaches of the Health Information Portability and Accountability Act, which does not cover many recent health apps and technologies, say Jodi Daniel and Brandon Ge at Crowell & Moring.
-
How Attys Can Avoid Exposing Their Firms To Cyberattacks
Attorneys are the weakest link in their firms' cyberdefenses because hackers often exploit the gap between individuals’ work and personal cybersecurity habits, but there are some steps lawyers can take to reduce the risks they create for their employers, say Mark Hurley and Carmine Cicalese at Digital Privacy & Protection.