DocWire News Editors

DocwireNews

The FDA recently joined the digital healthcare wave with its MyStudies app, a tool that is designed to collected patient generated health data (PGHD) to assist in conducting and developing clinical trials. The app will collect evidence from users&rsquo; mobile devices to increase the diversity of information available for researchers in clinical experiments as well as other healthcare research.Following the success of their pilot study partnered with Kaiser Permanente, the FDA has made the decision to release the open source code and documents researchers need to develop their own customized MyStudies apps.<a href="https://proddocwire.wpengine.com/uncategorized/study-sleepio-app-found-to-reduce-insomnia-using-digital-therapy/">READ MORE:&nbsp;Sleepio App Found to Reduce Insomnia Using Digital Therapy</a>These users can adapt the app to fit their personal clinical trial and patient-evidence needs, while still complying to the FDA&rsquo;s regulations regarding integrity, data authenticity, and confidentiality. MyStudies allows patients to securely contribute data to and enroll in various trials and studies, expanding researchers reach for participants with the use of smartphones and easy accessibility. Among the features these researchers can analyze are patient-reported outcomes and self-reports of prescription and over-the-counter drug use.&ldquo;There are a lot of new ways that we can use real world evidence to help inform regulatory decisions around medical products as the collection of this data gets more widespread and reliable,&rdquo; said FDA Commissioner Scott Gottlieb in a statement. &ldquo;Better capture of real world data, collected from a variety of sources, has the potential to make our new drug development process more efficient, improve safety and help lower the cost of product development.&rdquo;The MyStudies app strives to provide meet patient centered needs. It collects patient information from electronic-health records, claims, patient portal, and registries for products and diseases. In addition, these patients can also provide their patient generated health data from wearable devices like <a href="https://proddocwire.wpengine.com/docwire-pick/future-of-medicine-picks/new-apple-watch-can-monitor-heart-rate-and-detect-falls/">the Apple Watch</a>, remote monitoring devices, various other apps, and their own medical record-keeping.<a href="https://proddocwire.wpengine.com/docwire-pick/future-of-medicine-picks/apple-watch-partners-with-zimmer-biomet-in-surgical-recovery-study/">READ MORE:&nbsp;Apple Watch Partners With Zimmer Biomet in Surgical Recovery Study</a>&ldquo;If done right, it can also help make sure doctors and patients are better informed about the clinical use of new products, enabling them to make more effective, efficient medical choices,&rdquo; Gottlieb explained. &ldquo;This will ultimately help us achieve better outcomes, and safer and more efficient use of expensive technology.&rdquo;Though the FDA-branded app was removed from app stores after their pilot study, their open source code is being released for two versions of the MyStudies app, one designed for Apple&rsquo;s ResearchKit framework, commonly seen as iOS, and Google&rsquo;s Android ResearchStack framework.In their statement regarding the MyStudies app, the FDA lists important features of the app to be:&ldquo;The data storage environment is secure and supports auditing necessary for compliance with 21 CFR Part 11 and the Federal Information Security Management Act, so it can be used for trials under Investigational New Drug oversight.The app is configurable for different therapeutic areas, and health outcomes, which reduces software development hurdles for non-FDA users.The data storage environment is partitioned to support multi-site trials or &ldquo;distributed database&rdquo; studies.&rdquo;<a href="https://www.fda.gov/Drugs/ScienceResearch/ucm624785.htm">Read the full FDA statement here.&nbsp;</a><blockquote class="twitter-tweet" data-lang="en">
The digital tool is designed to enhance patient data gathering, drug development and safety monitoring. <a href="https://twitter.com/hashtag/digitalhealth?src=hash&amp;ref_src=twsrc%5Etfw">#digitalhealth</a> <a href="https://twitter.com/hashtag/medtech?src=hash&amp;ref_src=twsrc%5Etfw">#medtech</a> <a href="https://t.co/Azcx1CQ72S">https://t.co/Azcx1CQ72S</a>
&mdash; Healthcare Analytics News (@HCA_News) <a href="https://twitter.com/HCA_News/status/1062831289030635522?ref_src=twsrc%5Etfw">November 14, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>Sources: <a href="https://patientengagementhit.com/news/fda-mystudies-app-to-integrate-patient-data-into-clinical-trials">Patient Engagement HIT</a>, <a href="https://healthitanalytics.com/news/fda-launches-app-to-support-clinical-trials-real-world-evidence-collection">Health IT Analytics</a>, <a href="https://www.fda.gov/Drugs/ScienceResearch/ucm624785.htm">FDA</a>

Jayme Locke, MD, MPH

Joel M. Topf, MD, FACP

The Promise of Xenotransplantation

NKF Spring Clinical Meetings 2025

Leah Lawrence

Real-World Data Backs Invasive DFS as Surrogate Endpoint for OS in EBC

HR Breast Cancer

Sacituzimab Govitecan Showed Modest Activity for CNS Metastases

Triple-Negative Breast Cancer

Latest News

FDA Launches MyStudies App Allowing Users to Enroll in Studies

Telemedicine

The FDA recently joined the digital healthcare wave with its MyStudies app, a tool that is designed to collected patient generated health data (PGHD) to assist in conducting ...

About Us

Editorial Policy

Advertising

Contact Us

eNewsletters

Contribute

Career Center

MashupMD

Blood Cancers Today

Cancer Nursing Today

GU Oncology Now

Urban Health Today

Bile Duct Cancer

Colorectal Cancer

Gastroesophageal Cancer

Gastric Cancer

GEP-NETs

GIST

Liver Cancer

Pancreatic Cancer

GI Oncology Now

Anemia

Deep Vein Thrombosis

Essential Thrombocythemia

Hemophilia

Immune Thrombocytopenic Purpura

Myelodysplastic Syndromes

Myelofibrosis

Myeloproliferative Neoplasms

Polycythemia Vera

Pulmonary Embolism

Sickle Cell Disease

Thrombocytopenia

Thrombophilia

Thrombosis

Thrombotic Thrombocytopenic Purpura

Venous Thromboembolism

von Willebrand Disease

Heme Today

Acute Kidney Injury

ADPKD

Anemia and Kidney Disease

Chronic Kidney Disease

COVID-19 and Kidney Disease

Diabetes and Hypertension

End-Stage Renal Disease

Gout

Hyperkalemia

IgAN

Kidney Transplantation

Metabolic Acidosis

Nephrology Times

HER2 Breast Cancer

Genetics & Breast Cancer

Breast Cancers Today

Atherosclerotic Disease

Atrial Fibrillation

Heart Failure

Hypertension

Interventional Cardiology

Lipid Management

Practice Tips With Dr. Lichaa

Preventive Cardiology

Stroke

Cardiology

Breast Cancer

Gynecologic Cancer

Head and Neck Cancer

Skin Cancer

Oncology

Sleep

Urology

Diabetes

Ophthalmology

— Demodex Blepharitis

Neurology

Rheumatology

Gastroenterology

Pulmonology

Infectious Diseases

— HIV

Health and Wellness

Lupus

Future of Medicine

Orthopedics

Pharmacology

Career News

More

Conferences

CardioNerds

The Sleep Source With Dr. Morse

Rheumatology Rounds With Dr. Maheswaranathan

Partners

Expert Interviews

Subscribe