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Health Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Digital Health Care Investors Summit Highlights Digital Health Expansion

by Foley & Lardner LLP on

In early December, leading experts in digital health and telemedicine came together at the Digital Health Care Investors Summit hosted by Foley & Lardner LLP and Deloitte. The Summit explored innovations in digital health...more

Pill Mills, Poppy Flowers, Dead Poets and the Human Resources Department

Having been through a seven-week federal criminal “pill mill” trial, I think a lot about enforcement of the Controlled Substances Act and its effect on physicians. Aggressive enforcement effects others in healthcare as well,...more

Clarifying Digital Health and Software Regulation: FDA Releases Three New Guidance Documents

by Hogan Lovells on

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework for the regulation of software and digital health products to bring FDA...more

Diabetes Monitoring Technology Moving Toward Consumer Convenience

by Knobbe Martens on

The FDA recently approved Abott’s FreeStyle Libre Flash Glucose Monitoring System. According to Bloomberg, this device marks the first continuous glucose monitoring system that adults can use that does not use diagnosis via...more

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials...

by Hogan Lovells on

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more

Sandoz Announces Phase I Data For Its Pegfilgrastim Biosimilar

by Goodwin on

On December 8, 2017, Sandoz, a division of Novartis, announced data purportedly showing that its pegfilgrastim biosimilar candidate matches the reference biologic, Neulasta® in terms of pharmacokinetics, pharmacodynamics,...more

K&L Gates Triage: FDA & Health Care Update: The Use of Real-World Data and Real-World Evidence in Medical Product Development

by K&L Gates LLP on

In this episode, Erica Jackson discusses recent guidance from the Food & Drug Administration (FDA) on the consideration of real-world data and real-world evidence in regulatory decision-making related to medical devices and...more

OCR Warns Health Care Industry of Risks with Previous Employees

In its November newsletter, the Office for Civil Rights (OCR) made a great point that we are seeing in the industry—the risks associated with previous employees. According to its newsletter, entitled “Insider Threats and...more

Guest Post: Christmas Came Early on December 8 – Favorable Developments in Fosamax & Accutane Litigation

by Reed Smith on

This guest post is by Kevin Hara, an associate at Reed Smith and relatively frequent contributor to the Blog. Here, he discusses two recent favorable procedural developments in further appeals from two really awful decisions...more

FDA Issues Fourth and Final Software as a Medical Device Clinical Evaluation Guidance

by McDermott Will & Emery on

The FDA recently released “Software as a Medical Device (SAMD): Clinical Evaluation,” a final guidance document that aims to establish a common understanding of clinical evaluation and principles for demonstrating the safety,...more

Telehealth Opportunities Worth Watching in 2018

Continued physician shortages, reduced reimbursement from government and private insurance plans and the ever-increasing health care needs of an aging population are forcing payors and providers alike to increase the...more

EDNY Rejects Successor Liability in Hip Implant Case

by Reed Smith on

Happy birthday, Christopher Plummer. The great Canadian actor turns 88 today, and seems as vibrant as ever. What a marvelous career Plummer has had. He is a preeminent Shakespearean actor. We saw him play Iago to James...more

Draft Fee Regulations – Attempts to Address Incentivising Loopholes

by Hogan Lovells on

Section 18A of the South African Medicines Act (the “Medicines Act“) prohibits the supply of any medicine, medical device or in-vitro diagnostic device, according to a bonus system, rebate system or any other incentive...more

Saudi Arabia Update – November and December 2017

by Dentons on

Legal developments - Saudi Arabia anti-corruption drive and protection of corporates - In the wake of Saudi Arabia’s headline-grabbing anti-corruption drive in November, Crown Prince Mohammed bin Salman instructed the...more

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

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