The information contained on this page is intended to help digital health developers identify useful resources to build tools and solutions. For more info on navigating the regulatory aspects plus funding considerations, please visit the VC and Startup page.
A portion of this content was provided by Digital Health LinkedIn group members. To share your suggestions, please contact me.
Law and Regulatory Considerations
US Food and Drug Administration (FDA)
- FDA Digital Health page
- Deciding When to Submit a 510(k) for a Software Change to Existing Device; Draft Guidance for Industry and FDA
- FDA’s final guidance for low-risk digital health solutions “General Wellness: Policy for Low Risk Devices” – Jul 16, 2016
- FDA’s guidance on Mobile Medical Applications – The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery. – Feb 9, 2015
- FDA issues final guidance on mobile medical apps – Tailored approach supports innovation while protecting consumer safety – Sep, 23, 2013
US Federal Trade Commission (FTC)
- In conjunction with the FDA and HHS’ ONC and OCR, the FTC has released new guidance for developers of digital health apps. A companion web-based tool is intended to help developers and business determine applicable laws and regulations. (press release)
Tools, Tutorials, and Guides
- Arduino can sense the environment by receiving input from a variety of sensors and can affect its surroundings by controlling lights, motors, and other actuators.
- Cooking Hacks e-Health Sensor Platform V2.0 for Arduino and Raspberry Pi [Biometric / Medical Applications] – The e-Health Sensor Shield V2.0 allows Arduino and Raspberry Pi users to perform biometric and medical applications where body monitoring is needed by using 10 different sensors: pulse, oxygen in blood (SPO2), airflow (breathing), body temperature, electrocardiogram (ECG), glucometer, galvanic skin response (GSR – sweating), blood pressure (sphygmomanometer), patient position (accelerometer) and muscle/eletromyography sensor (EMG).
Tutorials and Guides
Group Member Recommendations
Michael Kremliovsky (LinkedIn profile)
- TI platform page for medical reference designs
- TI Medical Innovation Resources Page
- QP embedded programming framework
- Physionet tools (this is really must for ECG/EEG people)
- FDA 510(k) clearances database (predicates, competitors, etc)
- Android developers platform page for sensors
- Amazon Web Services – Computing infrastructure needs. It can also help you with SaaS components while you are making your mind how actually it is supposed to be built
- Information hub for embedded HW/SW developers
David Lee Scher, MD (LinkedIn profile)
Eric Jain (LinkedIn profile)
Vivek Narayan MD, MMSoc, MBA (LinkedIn profile)
- Open EHR – An open domain-driven platform for developing flexible e-health systems
- U.S. Department of Health and Human Services Agency for Healthcare Research and Quality – Healthcare Cost and Utilization Project (HCUP)
Sumesh Sundareswaran, MBA, CPHIMS, PMP (LinkedIn profile)
- HL7 workgroup for mHealth – Standards for data interoperability
- Force.com provides a platform and tutorials on how to create on-demand apps
- ISO/IEEE 11073 – CEN ISO/IEEE 11073 Health informatics – Medical / health device communication standards enable communication between medical, health care and wellness devices and with external computer systems. They provide automatic and detailed electronic data capture of client-related and vital signs information, and of device operational data.
- IEC 80001 – Application of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities and activities
Standards & Interoperability Organizations
- Continua Health Alliance – Continua Health Alliance is a non-profit, open industry organization of healthcare and technology companies joining together in collaboration to improve the quality of personal healthcare.
- Bluetooth SIG – The Bluetooth SIG is a global trade association with over 20,000 member companies
- ANT+ – ANT, the technology for practical wireless sensor network. ANT+, connecting sensors for life.
- ZigBee Alliance – ZigBee offers green and wireless standards connecting the widest range of devices to work together intelligently and help you control your world.
- Wi-Fi Alliance – Wi-Fi Alliance is the worldwide network of companies that bring you Wi-Fi.
- WIMAX Forum – WiMAX technology is a mature, affordable solution for high-speed 4G mobile broadband.
- DASH7 Alliance – The DASH7 Alliance, formed in 2009, promotes the use of sub 1GHz Radio Technology based on the Alliance Mode Protocol, chip development and device productization and offers such interoperability to standards bodies, Industry associations and related government entities in order to accelerate adoption and advance integration for the benefit of society.
- Health Data Consortium
- Wireless-Life Sciences Alliance (WLSA)
- Continua Health Alliance
- European Connected Health Alliance (ECHAlliance)
- mHealth Alliance
- mHealth Working Group
- American Telemedicine Association (ATA)
- American Medical Informatics Association (AMIA)
- mHealth Regulatory Coalition (MRC)
- New York eHealth Collaborative (NYeC)
- CTIA – The Wireless Association is an industry trade group that represents the international wireless telecommunications industry.
- GSMA – The GSM Association is an association of mobile operators and related companies devoted to supporting the standardising, deployment and promotion of the GSM mobile telephone system.
- NFC Research Lab (Near Field Communication)