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Understanding the Uptake of Big Data in Health Care: Protocol for a Multinational Mixed-Methods Study

Understanding the Uptake of Big Data in Health Care: Protocol for a Multinational Mixed-Methods Study

New regulations (or national policies) can be expected to affect (possibly limit) the opportunities available to the pilots (eg, the EU General Data Protection Regulation [GPDR] legislation could have major consequences for pilots working with international

Rik Wehrens, Vikrant Sihag, Sandra Sülz, Hilco van Elten, Erik van Raaij, Antoinette de Bont, Anne Marie Weggelaar-Jansen

JMIR Res Protoc 2020;9(10):e16779


Mind the App: Considerations for the Future of Mobile Health in Canada

Mind the App: Considerations for the Future of Mobile Health in Canada

In this context, the demand for the regulation of mobile health apps has increased [4].Health Canada’s Draft GuidanceIn January 2019, Health Canada issued draft guidance on the regulation of software as a medical device (SaMD).

Ma'n H Zawati, Michael Lang

JMIR Mhealth Uhealth 2019;7(11):e15301


Characteristics of Neuropsychiatric Mobile Health Trials: Cross-Sectional Analysis of Studies Registered on ClinicalTrials.gov

Characteristics of Neuropsychiatric Mobile Health Trials: Cross-Sectional Analysis of Studies Registered on ClinicalTrials.gov

The topic of digital health regulation by the Food and Drug Administration in the United States has been a news story since the fall of 2019 when it was discussed by a presidential candidate.Currently, one path to increase scientific validity and transparency

Mia Tova Minen, Julia Frederica Reichel, Pallavi Pemmireddy, Elizabeth Loder, John Torous

JMIR Mhealth Uhealth 2020;8(8):e16180


Regulatory Sandboxes: A Cure for mHealth Pilotitis?

Regulatory Sandboxes: A Cure for mHealth Pilotitis?

In the United States, for example, this public health emergency has accelerated negotiations about regulation and remuneration in telemedicine that had otherwise stalled for years [18].

Abhishek Bhatia, Rahul Matthan, Tarun Khanna, Satchit Balsari

J Med Internet Res 2020;22(9):e21276


A Good Practice–Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study

A Good Practice–Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study

to describe the methods, considerations, and recommendations for the development and validation of CTIMS from a range of different perspectives.MethodsExtraction of Regulatory RequirementsBased on the 2018 FDA imaging guidance, which is the most important regulation

Youngbin Shin, Kyung Won Kim, Amy Junghyun Lee, Yu Sub Sung, Suah Ahn, Ja Hwan Koo, Chang Gyu Choi, Yousun Ko, Ho Sung Kim, Seong Ho Park

JMIR Med Inform 2019;7(3):e14310


COVID-19 Research: Navigating the European General Data Protection Regulation

COVID-19 Research: Navigating the European General Data Protection Regulation

The General Data Protection Regulation (GDPR) [3] regulates the processing of personal data in the European Economic Area (EEA), which includes the 27 European Union Member States as well as Iceland, Liechtenstein, and Norway.

Regina Becker, Adrian Thorogood, Johan Ordish, Michael J.S. Beauvais

J Med Internet Res 2020;22(8):e19799


Public Opinion About E-Cigarettes on Chinese Social Media: A Combined Study of Text Mining Analysis and Correspondence Analysis

Public Opinion About E-Cigarettes on Chinese Social Media: A Combined Study of Text Mining Analysis and Correspondence Analysis

The first national-level regulation on e-cigarettes in China was released in August 2018, when China’s State Administration for Market Regulation and STMA jointly issued the Notice on Prohibiting the Sale of Electronic Cigarettes to Minors.

Di Wang, Joanne Chen Lyu, Xiaoyu Zhao

J Med Internet Res 2020;22(10):e19804


Efficacy and Outcomes of a Music-Based Emotion Regulation Mobile App in Distressed Young People: Randomized Controlled Trial

Efficacy and Outcomes of a Music-Based Emotion Regulation Mobile App in Distressed Young People: Randomized Controlled Trial

Effective emotion regulation skills may help decrease the intensity and duration of dysphoric states, whereas ineffective emotion regulation may increase them [3].Only a third of young people with mental disorders seek help [11] and many fail to engage in or

Leanne Hides, Genevieve Dingle, Catherine Quinn, Stoyan R Stoyanov, Oksana Zelenko, Dian Tjondronegoro, Daniel Johnson, Wendell Cockshaw, David J Kavanagh

JMIR Mhealth Uhealth 2019;7(1):e11482