Digital Health & Technology
-
January 19, 2024
Law360 Names Practice Groups Of The Year
Law360 would like to congratulate the winners of its Practice Groups of the Year awards for 2023, which honor the attorney teams behind litigation wins and major deals that resonated throughout the legal industry this past year.
-
January 19, 2024
Lawmakers Urge HHS To Make Telehealth Policy Permanent
A bipartisan group of senators and representatives on Friday pressed the U.S. Department of Health and Human Services to make permanent the temporary pandemic-era expansions in Medicare telehealth coverage before the end of the year.
-
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.
-
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.
-
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.
Expert Analysis
-
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.
-
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.
-
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.
-
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.
-
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.
-
What CMS E-Records Proposal Means For Hospitals
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
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
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
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
Excerpt from Practical Guidance
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
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
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
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.