Parallel 6 Appoints David Lee Scher, M.D., Pioneer in Digital Health Technology, as its Chief Medical Advisor to Scientific Advisory Board -
Parallel 6, an enterprise mobile technology company, has appointed David Lee Scher, M.D. as the Chief Medical Advisor of Parallel 6's Scientific Advisory Board. As a practicing cardiac electrophysiologist for more than 25 years and an experienced clinical trial investigator, his expertise makes him a knowledgeable resource to Parallel 6's Clinical Reach, an end-to-end technology solution for clinical trial recruitment and retention. His dedication to merge healthcare and technology is recognized worldwide as he travels globally to speak about the necessity of mobile health technologies, as outlined in his blog 'Five Reasons Why Mobile Technology Needs Clinical Trials.' -
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The use of mobile health apps has not accelerated as quickly as industry pundits predict.
Mobile health apps can be classified as
1. Consumer oriented for accumulating data for evaluation of fitness,reporting on exercise routines. These are wearable devices and do not communicate activities in real time.
2. Patient portals for clinics, hospitals, and to give patients access to laboratory results, imaging reports, messaging, appointments
3. EHR mobile applications to add mobile functionality for providers, and hospitals
4. Provider oriented
Consumer oriented mobile health apps are readily available for download at the iTunes store for iOS ( Apple products, ie iPad, iPhone, iMac and Macbook.)
Mobile apps span a wide range of health functions. While many mobile apps carry minimal risk, those that can pose a greater risk to patients will require FDA review.
Please visit the mobile medical apps example page for a list of examples of mobile medical apps that have been cleared or approved by the FDA. Visit the Examples of MMAs the FDA regulates webpage for a more detailed list of examples of mobile apps that would require FDA review.
Mobile apps for which the FDA intends to exercise enforcement discretion
For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile medical apps that:
- Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
- Provide patients with simple tools to organize and track their health information;
- Provide easy access to information related to health conditions or treatments;
- Help patients document, show or communicate potential medical conditions to health care providers;
- Automate simple tasks for health care providers; or
- Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.
For a more detailed list of examples of these types of mobile medical apps that do not require FDA review, please visit the webpage Examples of Mobile Apps for which the FDA will exercise enforcement discretion.
The FDA issued guidance for FDA drug and device staff. (pdf download)
Mobile Medical Application (Mobile Medical App)
For purposes of this guidance, a “mobile medical app” is a mobile app that meets the definition
of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
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; and
either is intended:
· to be used as an accessory to a regulated medical device; or
· to transform a mobile platform into a regulated medical device.
