What is Digital Health? | FDA - U.S. Food and Drug Administration
Digital health includes mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.
Digital Health Center of Excellence | FDA - U.S. Food and Drug ...
Dec 3, 2024 · Our goal: Empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation. Our objectives: The Digital Health Center of Excellence aims to:...
TeleHealth and Rural Communities www.fda.gov •FDA recognizes telehealth as an important tool for healthcare delivery in rural communities •We aim to advance innovation and development in digital health while ensuring patient safety and effectiveness of telehealth devices
TeleHealth and Rural Communities www.fda.gov • FDA recognizes telehealth as an important tool for healthcare delivery in rural communities • We aim to advance innovation and
To avoid FDA’s scrutiny and liability under the FDC Act, providers who offer telemedicine services to enable patients to obtain prescription medications should ensure that the products they prescribe and dispense will not be considered misbranded or unapproved.
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
Aug 30, 2024 · The practice of telemedicine is being conducted during a public health emergency declared by the Secretary of Health and Human Services under section 319 of the Public Health Service Act (42...
Telehealth Systems - StatPearls - NCBI Bookshelf
Sep 12, 2022 · Telehealth is the use of a technology-based virtual platform to deliver various aspects of health information, prevention, monitoring, and medical care. The fastest growing sector of health care, telehealth's largest segment is telemedicine.
Telehealth: Applications From a Legal and Regulatory Perspective
Telehealth is becoming mainstream in the U.S., as more consumers, employers, hospital systems, and even insurers adopt the technology. The authors explore the challenges of regulation, reimbursement, and licensing as the modality evolves.
FDA Eases Guidelines for New mHealth, Telemental Health …
Apr 21, 2020 · The FDA is relaxing certain guidelines for new mHealth and digital therapeutic apps and telehealth tools to help patients and providers access mental health resources during the COVID-19 emergency.
DEA Announces Proposed Rules for Permanent Telemedicine …
Feb 24, 2023 · The proposed rules would provide safeguards for a narrow subset of telemedicine consultations—those telemedicine consultations by a medical practitioner that has: never conducted an in-person evaluation of a patient; AND that result in the prescribing of a …