The digital health space refers to the integration of technology and health care services to improve the overall quality of health care delivery. It encompasses a wide range of innovative and emerging technologies such as wearables, telehealth, artificial intelligence, mobile health, and electronic health records (EHRs). The digital health space offers numerous benefits such as improved patient outcomes, increased access to health care, reduced costs, and improved communication and collaboration between patients and health care providers. For example, patients can now monitor their vital signs such as blood pressure and glucose levels from home using wearable devices and share the data with their doctors in real-time. Telehealth technology allows patients to consult with their health care providers remotely without having to travel to the hospital, making health care more accessible, particularly in remote or rural areas. Artificial intelligence can be used to analyze vast amounts of patient data to identify patterns, predict outcomes, and provide personalized treatment recommendations. Overall, the digital health space is rapidly evolving, and the integration of technology in health
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monday, July 6, 2015

Habits of Physicians Posting for Professional Purposes

The following information is gleaned from

Kantar Media Healthcare Research Insights

Kantar Media Healthcare Research Insights





Kantar Media is a pharma research company offering insights to drug manufacturers. The information also reflects directly back to MD usage of social media. 


















Many physicians still are reticent to use social media. If you have not looked at social media in the past two years you would not know about the uptick for #hcsm. Users in all fields of medicine and health businesses, including device manufacturers, pharma, laboratories, and government. (FDA,HHS,CMS,WHO and more use social media for marketing and information purposes.

While most use Google to search for subjects you may notice that significant number of replies yield twitter, facebook, or Google + pages.  It is not at all unusual to see twitter handles and facebook page links on professional web sites.  If you want to remain strictly professional Linkedin has grown explosively in the last 12 months.  Building a profile on any of those sites or opening an about.me page will yield results.  About.me  is an eye catching site with creative graphics. It is much more interesting to read than a curriculum vita.

Kantar Media Healthcare Research Insights



Kantar Media Healthcare Research Insights  




Uncovered some some specific insights about physicians and their professional social network usage. When it comes to posting on social media in a professional capacity, there are certain trends we can notice. We know that a doctor sharing an article is much more likely to be embracing new medical technology or drugs.
One of the trends we're noticing is that professional social networks are surpassing other platforms in terms of popularity and content shared. Our study results show that 58% of physicians that write/post on social networks for professional purposes choose to write/post on professional social networks vs. consumer or medical association social networks. What does this mean for advertisers? Well, potentially you as an advertiser should establish more of a presence on professional networks.
If you sell new pharmaceuticals to doctors, there's definitely some good news from the March 2015 edition of the Sources & Interactions™ StudyPhysicians that write/post on social networks for professional purposes are more likely to be new drug adopters. Is social media advertising part of your media plan? It should be: 67% of respondents are saying they prefer to adopt drugs as soon as they are released or after a few others have tried it successfully. The fact is that medical professionals using professional social media are among the most receptive to new pharmaceuticals and you don't want to miss out on that group.
Sales teams should embrace these findings as well. Among this demographic using social media, 83% of them say they see sales reps—10 percentage points higher than the total physician population that see sales reps. It's clearly evident that social media needs to be a tool you utilize to reach the newest drug adopters. 
The Sources & Interactions™ Source is a detailed examination of doctors’ online and mobile activities, e-detailing experience, and exposure to (and evaluation of) information sources including traditional and emerging media, pharma reps, CME, convention and more. The study is conducted every six months and targets more than 3,000 physicians annually across 22 specialties, exploring their media preferences and habits. Sources & Interactions was designed to help marketers and their agencies cost-effectively allocate resources to their overall promotional mix, and provide publishers with specific insight about where their offerings fit into physicians (and other healthcare professionals’) information inventory.tudy

Sources & Interactions, March 2015: Medical/Surgical Edition


Kantar Media’s Sources & Interactions™ Studies offer detailed research on healthcare professionals’ online and mobile activities, e-detailing experience, and exposure to (and evaluation of) information sources including traditional and emerging media, pharma reps, CME, conventions and more. Sources & Interactions helps marketers and their agencies cost-effectively allocate resources to their overall promotional mix, and provide publishers with specific insight about where their offerings fit into physicians’ (and other healthcare professionals’) information inventory.


The Medical/Surgical edition is conducted every six months,with brand new data available now!



Friday, July 3, 2015

Ingestible Sensor technology--Wearable, on the Inside

First Medical Device Cleared by FDA With Adherence Claim


Patient ingests medication by mouth


Wireless Receiver Applied to arm or abdomen, transmits signal to Smart Device
or other monitor








Micro-chip embedded in Pill
Proteus Digital Health, Inc. today announced that the FDA has expanded the Indications for Use statement for the latest generation of its Ingestible Sensor technology, enabling the device to be used as an aid in the measurement of medication adherence. To the Company’s knowledge, this is the only device with an FDA-sanctioned claim for measuring medication adherence.
“We are delighted that our collaborative work with the FDA continues to enable positive progress”
An estimated 50% of us do not take our medicines as prescribed, potentially limiting the therapeutic effectiveness of our medicine and resulting in $100-300 billion in avoidable healthcare costs in the US alone due to unnecessary escalation of treatment.1 There have been many efforts to address this challenge but no products have previously been cleared by the FDA for aiding in the measurement of adherence until now.
“We are delighted that our collaborative work with the FDA continues to enable positive progress,” said Proteus Co-Founder and Chief Medical Officer Dr. George Savage. “We believe that ingestible devices have the potential to speed clinical trials and improve the real-world effectiveness of medicines in community settings.”
When used with a medication, the Proteus Ingestible Sensor marks actual intake time, a quantifiable event that has allowed regulators to grant the expanded indication to the company. The Ingestible Sensor was approved by the FDA in 2012 and communicates with an adhesive patch, worn on the torso. The Proteus Patch records time of ingestion along with steps, rest and heart rate, and communicates to a mobile app via Bluetooth.
As many players enter the wearables space, Proteus Digital Health is leading a new ingestible category in order to derive unprecedented insights about medication-taking behavior and physiologic response to therapy. Proteus is the only company that combines ingestible, wearable, mobile and cloud computing.
About Proteus Digital Health®
Proteus is creating a new category of therapy: Digital Medicines. Digital Medicine therapy includes drugs that communicate when they’ve been taken, wearable sensors that capture physiologic response, applications that support patient self-care and physician decision making, and data analytics to serve the needs of doctors and health systems. The goal of Digital Medicines is to empower patients and their families, enable physicians and health systems to more effectively manage risk and ensure that outcomes are reliably achieved.
Proteus received FDA market clearance in the United States and a CE mark in Europe for its wearable and Ingestible Sensor devices. 

Wednesday, February 11, 2015

A Boost for Mobile Health


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.' - 




This article was originally distributed on PRWeb. For the original version including any supplementary images or video, visit - See more at:


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.) 





Many are also available on the Google Chrome Store
















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.
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) - 7 - 4 ; 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.

Keeping Up with Progress in Mobile Medical Apps