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Data Collection Medical Devices

Butler Snow LLP

The Wearable Revolution: How to Use Personal Health Device Data in Litigation

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Wearable technology compiles extensive information on our bodily systems—including activity levels, menstruation and fertility, exercise activity and attainment, food consumption, weight, sleep, noise exposure, heart rate,...more

Epstein Becker & Green

Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not...

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more

Gardner Law

FDA Issues Draft Guidance on Real-World Evidence Use

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In December 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of real-world evidence to support regulatory decision-making for medical devices. While the guidance is currently in draft form...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 110

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This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

Gardner Law

Med-Tech Meets High-tech: Privacy, Cybersecurity and Ai in Connected Devices

Gardner Law on

...Innovation in connected medical devices is critical to advances in health care outcomes, user experience, and reducing costs. These exciting technologies also can be challenging when it comes to navigating the complex...more

McDermott Will & Emery

Remote Monitoring and Digital Therapies: CMS Updates Coverage and Payment Policies

McDermott Will & Emery on

In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more

Foley & Lardner LLP

Top 5 Rules for Medicare 2024 Remote Patient Monitoring and Remote Therapeutic Monitoring: What Companies Need to Know

Foley & Lardner LLP on

On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) finalized new policies related to remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

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FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Illinois Federal Judge Says Prevailing BIPA Defendants Must Show Bad Faith for Attorneys’ Fees

An Illinois federal court recently rejected an online eyewear retailer’s request for attorneys’ fees as the prevailing party in a Biometric Information Privacy Act (BIPA or Privacy Act) class action over its virtual try-on...more

Womble Bond Dickinson

Automated External Defibrillators: An Untapped Source of Medical Records?

Womble Bond Dickinson on

An estimated 350,000 out-of-hospital cardiac arrest deaths occur each year in the U.S. Approximately 10% of those who experience out-of-hospital cardiac events survive. Use of automated external defibrillators (AED), however,...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Illinois Federal Judge Finds Another Eyewear Virtual Try-on Class Action Is Exempt Under BIPA’s Healthcare Exemption

A federal judge in Illinois recently ruled that online shoppers cannot sustain claims that a virtual try-on (VTO) tool that allegedly scans facial geometry to preview the look of sunglasses on their face violates the...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 3, March 2023

Amazon Sued for Not Telling New York Store Customers about Tracking Biometrics - “Thanks to a 2021 law, New York is the only major American city to require businesses to post signs letting customers know they’re tracking...more

Fenwick & West LLP

Increased Regulatory Scrutiny on Health Technology Companies’ Use of Advertising Technologies

Fenwick & West LLP on

The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Volume 3, Issue 16

CHIPS and Science Act Will Lower Costs, Create Jobs, Strengthen Supply Chains, and Counter China "Spurred by the passage of the CHIPS and Science Act of 2022, companies have announced nearly $50 billion in additional...more

Health Care Compliance Association (HCCA)

'Ecosystem' of Connected Devices Heightens Cybersecurity Risk

Report on Medicare Compliance 31 no. 18 (May 16, 2022) - In a version of the future that hopefully never comes, malware is able to remove malignant-looking tumors from CT or MRI scans before they were reviewed by...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - April 2022

In this month’s Privacy & Cybersecurity Update, we examine the FTC chair’s comments suggesting a potential shift in its approach to data privacy regulation, the European Data Protection Board’s request for comment on its...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 3, Issue 5

The Cryptocurrency Revolution and President Biden's Formal Recognition - Out of the ashes of the 2008 financial crisis, Bitcoin sprang up like an insurgency, targeting both the unbridled activity of large financial...more

King & Spalding

A Pandemic Silver Lining: FDA’s New Guidance on Using Digital Health Technologies for Clinical Investigations

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With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - January 2022

In this month’s Privacy & Cybersecurity Update, we examine the U.S. Chamber of Commerce’s letter to Congress calling for federal cybersecurity legislation, the New York attorney general’s report on “credential stuffing”...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations

n December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from...more

King & Spalding

A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making

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In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 2, Issue 21

Nature of Patents and Patent Rights - When a patent is issued under the seal of the United States Patent and Trademark Office, it is signed by the Director of the USPTO or an Office official. The patent contains a grant...more

Stinson LLP

Health App Vendors Be Warned: You Could Be Subject to FTC's Health Breach Notification Rule

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The surge in new health apps and connected devices, which only increased during the pandemic, continues to raise many legal and ethical questions. As a result, lawmakers have been scrambling to define the obligations...more

Hanzo

Complying With the FDA’s Advertising Regulations: Why You Need an Interactive Website Archive

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Pharmaceutical advertising is big business. In 2020, pharmaceutical companies spent more than $6.5 billion on advertising. The Food and Drug Administration (FDA) regulates advertisements of prescription drugs, but it...more

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