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Science, Computers & Technology Health

Read Science, Computers & Technology updates, news, alerts, and legal analysis from leading lawyers and law firms:

Proposed Law Would Criminalize Failures to Report Data Breaches

A draft bill recently introduced in the U.S. Senate serves as a good reminder that compliance with data breach reporting requirements is critical. This bill follows significant, high-profile data breaches by Uber and Equifax,...more

Health Alert (Australia) 11 December 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 1 December 2017 - Laerdal Medical Pty Ltd and Comptroller-General of Customs AATA 2427 - CUSTOMS – whether subject goods accessory –...more

FDA Issues Guidance on Digital Health

by Stinson Leonard Street on

The Food and Drug Administration (FDA) issued two guidance documents last week clarifying its approach to certain health-related software in response to the addition of Section 520(o) to the Food, Drug and Cosmetic Act, which...more

Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications

by Ropes & Gray LLP on

What are the legal implications of using social media and mobile applications in clinical trials and the recent developments impacting research fraud investigations? In this recap of our fourth quarter presentation, which...more

Texas Telemedicine Saga Finally Over? The Texas Medical Board Substantially Revises Telemedicine Regulations

The Texas Medical Board’s (the “Board”) adoption of new telehealth licensing regulations may finally put to bed long-running challenges to the state’s historically rigid position with respect to healthcare services delivered...more

Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology

by Holland & Knight LLP on

On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more

FDA Provides Guidance on 3D-Printed Medical Device Products

by Knobbe Martens on

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more

FDA Clears First Apple Watch Medical Device Accessory

by Knobbe Martens on

The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand. According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG...more

EMA launched improved version of EudraVigilance

by Hogan Lovells on

The European Medicines Agency (“EMA”) has launched a new and improved version of EudraVigilance. EudraVigilance is the system for managing and analysing information concerning suspected adverse reactions to medicinal products...more

Innovator Liability – A Word to the Wise

by Reed Smith on

A lot of us attended the annual ACI Drug & Medical Device Litigation Conference in New York City last week. One of the messages sent loud and clear from the initial client round table panel is that our clients don’t like...more

FDA Publishes Draft Guidance on CDS Software and Revises Medical Software Policies

by McDermott Will & Emery on

On December 7, 2017, the US Food and Drug Administration (FDA) published a highly anticipated draft guidance document that describes how the agency intends to exercise oversight over clinical decision support (CDS) software....more

FDA Includes Patent Submission Date Updates In Orange Book

by Tarter Krinsky & Drogin LLP on

The U.S. Food and Drug Administration (FDA) recently updated the Orange Book to include patent submission dates. A patent submission date is the date the FDA receives patent information from the NDA holder. For each patent...more

DHS Issues Draft Opioid Prescribing Guidelines

by Stinson Leonard Street on

In an effort to combat the ongoing epidemic of opioid misuse and opioid-related morbidity and mortality, the Minnesota Department of Human Services (DHS) Opioid Prescribing Work Group (OPWG) recently issued Draft Opioid...more

Henry Ford Health System Notifies 18,000+ Patients of Health Data Breach

On December 6, 2017, Henry Ford Health System (HFHS) disclosed that health information of 18,470 patients may have been viewed or stolen. HFHS became aware of the incident on October 3, 2017 after employee credentials were...more

Through a Glass Darkly: The Latest Health Care Deals Signal a Further Shift in Control and the Locus of Care

by Epstein Becker & Green on

Two merger announcements this week—one concerning CVS’s intention to acquire Aetna and the other concerning United/Optum’s intention to acquire DaVita’s physician group—have health investors and strategists peering over the...more

“Tap Here For A Doctor” – The Proliferation of Telemedicine In The Gig Economy

by Fisher Phillips on

Several years ago, many people were leery of the thought of ordering personal drivers through a mobile app and getting into a car of a complete stranger. However, over time, the idea of ride-sharing through Uber or Lyft has...more

The FCC to Propose Major Changes to Its Rural Health Care Funding Programs

The Federal Communications Commission (FCC) is launching a major revision to its Rural Health Care (“RHC”) subsidy programs. These revisions would address two main issues, the level of funding and ways to make the programs...more

Slow and Steady – CMS Expands Telehealth Reimbursement Opportunities in 2018

by McDermott Will & Emery on

The Centers for Medicare & Medicaid Services (CMS) reiterated its commitments to expanding access to telehealth services and paying “appropriately” for services that maximize technology in the Medicare Program; Revisions to...more

Americans For Medical Progress Premieres An Extraordinary Video That Describes The Incredible Need For And Contribution Of Animals...

by Fox Rothschild LLP on

Americans for Medical Progress (AMP) “supports research involving animals when it is necessary to advance our understanding of biological processes.” and provides tools for “public outreach that builds understanding and...more

FDA Takes Further Actions to Encourage Digital Health Innovation, Issuing CDS, Medical Software, and SaMD Guidance Documents

Today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is issuing three new, significant policy documents to advance FDA’s approach to the development and...more

Automated External Defibrillator Drones – Saving Lives One Flight at a Time

Drones have infiltrated almost all aspects of our lives. They have even infiltrated the medical world. One of the most useful ways drones have emerged in the medical world is as a vehicle for delivery of automated external...more

Guest post – Observations on FDA 3D Printing Guidance

by Reed Smith on

A lot has happened over the past 19 months, some good, some bad, and some just unbelievable. To name a few, and without sounding like a remake of We Didn’t’ Start the Fire, a total solar eclipse, a new human organ was...more

FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing

by Reed Smith on

The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration...more

Legislation, Lawsuit Cloud Future of 340B Program Payment Rate Reductions

by Jones Day on

The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more

Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D Proposed Rule (Proposed Rules) by setting out a...more

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