Medical Writing Artificial intelligence and Digital Health What medical writers need to know about regulatory approval of mobile health and digital healthcare devices

Volume 28, Issue 4 - Artificial intelligence and Digital Health

What medical writers need to know about regulatory approval of mobile health and digital healthcare devices

Abstract

The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk classification, quality management, and clinical evaluation. The EU Medical Devices Regulation (MDR), applicable from May 26, 2020, onwards, specifically addresses SaMDs and adopted aspects of IMDRF guidance. In particular, Rule 11 of the MDR will have significant implications, as many products so far not classified as medical devices or as class I, may be considered class IIa, IIb, or III medical devices. The entry of technology firms into the medical device field will further drive mHealth and the incorporation of novel technologies into SaMD. This article aims to provide the relevant regulatory background information for medical writers who are requested to support the preparation of the regulatory and clinical documentation for SaMD required for MDR compliance.

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References

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Articles

Table of Contents
Artificial intelligence and digital health
President's Message
EMWA News
Medical writing in the era of artificial intelligence
Blockchain in healthcare, research, and scientific publishing
Embracing a new friendship: Artificial intelligence and medical writers
Drug development and medical writing in the digital world
Intelligent use of artificial intelligence for systematic reviews of medical devices
What medical writers need to know about regulatory approval of mobile health and digital healthcare devices
Digitalisation in long-term care: An issue for medical writers?
An introduction to medical affairs for medical writers
A primer on anonymisation
Sound, microphone, action: Podcasts for medical writers
Regulatory Matters
News from the EMA
Lingua Franca and Beyond
In the Bookstores
Getting Your Foot in the Door
Medical Devices
Veterinary Medical Writing
Teaching Medical Writing
Journal Watch
Medical Communications and Writing for Patients
Good Writing Practice
Out on Our Own
Upcoming issues of Medical Writing

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Editor-in-Chief

Raquel Billiones

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Evguenia Alechine

Jonathan Pitt

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Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

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Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Morris

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

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Chris Monk