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

Friday, January 6, 2017

CES 2017 & JP Morgan Healthcare Conference.

This week, the digital health world's attention is on two mega events CES: 2017 and the JP Morgan Healthcare Conference.

At CES 2017 most of the consumer devices never come to market, for one reason or another. Attendees at the annual event may give tepid reviews to the shiny new toys. Many attendees are there to see each other in a
networking event.
The JP Morgan Healthcare Conference which takes place about a week after  CES 2017 focuses more on the nitty gritty of how investors evaluate the shiny new goods. It probably is no accident that the events are close together and in the order of which they are held.

Both of these events help to provide insights into new digital health innovations (particularly for consumers) and how key industry players perceive and use digital technologies. CES 2017 and JP Morgan Healthcare are international in scope, but U.S.-based firms have dominated the news (and buzz) coming from these events.

One of the reasons the U.S. has driven the digital health market over the last five years is that the regulatory, legal and technological trends originating here have helped to accelerate the uptake of digital innovations throughout the world. Innovators globally view the U.S. market as more open to innovation and as a place where the opportunities to build and sustain digital-focused companies are the most prevalent.

From an investment perspective, U.S.-focused funding activity has been a key metric, or proxy, for the health of the global digital health market. And, because the U.S. has been so dominant, increases (or decreases) in funding levels in America have sparked positive (or negative) reactions from market observers. However, especially in 2015 and 2016, there have been signs that global digital health investment (and innovation activity) has been increasing. In fact, the day may soon come when the U.S. is no longer the center of gravity in digital health.

The most recent evidence for this shift in the global digital health market comes from Rock Health and StartUp Health's Q4 2016 investment reports. Rock Health focuses on tracking U.S. deals ($2 million and higher). They found that overall funding levels decreased slightly year over year ($4.2 billion in 2016 versus $4.6 billion in 2015), but companies received higher levels of funding.

StartUp Health, on the other hand, which monitors global investment activity (and deals less than $2 million), reported another record year for digital health investment, a total of $7.9 billion. Interestingly a major story of 2016 was the number of significant non-U.S. investments in digital health. Steven Krein, StartUp Health's co-founder, highlighted the significance of these global deals saying (according to MM&M): "I think the international component to the industry is visible by the top two biggest deals that were done — the idea that this is not a transformation in the industry in the United States alone."

Non-U.S. Digital Health Activity Has Always Been Important, It's Just Becoming More Visible

It's no secret that the U.S. digital health market may face some difficult times in 2017. The uncertain U.S. health policy environment may cause large industry players to continue existing initiatives but be leery of making significant new investments in the short-term.

However, outside the United States, the picture is very different and digital health activity is only accelerating. In the United Kingdom, the NHS is pouring significant resources into a bid to accelerate digitization (to save money). Australia's push toward electronic medical records and the increased use of health data has been rocky, but policymakers there are committed to making it work. And, in India and China, an underdeveloped health infrastructure coupled with increasing demand for health services is spurring experimentation in a range of consumer and clinician-facing technologies, some of them have artificial intelligence baked in. These market forces have led to increased investment activity in Asia, Europe and other parts of the world. 

While these developments may come as a surprise to some, digital health innovation activity in non-U.S. markets has been growing for some time. But, these trends have gone largely under-reported and under-recognized by many observers, as they have been focused mainly on the U.S. market.

In fact, as early as 2015, there were signs that innovation activity in a range of key sectors such as sensors Big Data and artificial intelligence was increasing globally. For example, take a look at the chart below. It shows where innovation activity was being reported globally in mid-March 2015 in the area of sensors. You'll notice that, in addition to the U.S., other areas of focus include the United Kingdom and South Africa.

Global Areas of Innovation Focus: Sensors, Mid-March 2015
Image

Globally, innovation activity tends to be centered around innovation hubs so it's worth closely watching what innovations are most mentioned in relation to various major cities. Looking at London and Johannesburg (the graph below), one sees that, in relation (and addition) to sensors, Big Data, mobile and augmented reality and even robotics were also areas where sensor technology was being deployed in both countries.

Sensor-Related Innovation Areas of Focus: London, Johannesburg, Mid-March 2015
Image

This (and other data) indicates just how active people in non-U.S. markets have been from a digital health innovation perspective for a number of years now. This activity will only become more visible as investors continue to make big bets on digital health across Asia, Africa, Europe and other parts of the world. If your digital health focus is only on the U.S. you're going to be missing an ever-bigger part of the picture.

Where Does This Data Come From & How Can You Access It? 

The charts above were generated using version 2.0 of our DigiHealth Informer intelligence platform. This technology helps you track, organize, categorize and visualize real-time digital health market data from mainstream, social, research and other sources to uncover vital intelligence about investment activity, innovations, organizations, startups and other business-critical topics.

DigiHealth Informer 2.0 will launch in a few weeks with a special virtual event. During this Webinar I'll share additional data-grounded insights about where global digital health is going in 2017 and beyond. You'll also learn how you can benefit from (and access) DigiHealth Informer 2.0.

Interested in attending this event? Click the button below to be automatically subscribed to the launch email list. 

Sign Up for the Launch List

Talk soon,

Fard Johnmar
Founder, President
Enspektos, LLC

Monday, January 2, 2017

How to Apply for Software as a Medical Device SAAMD

Preface    

Software as a medical device is a concept previously unregulated until recently.  We are all familar with IDE (Investigative Device Exemption) as it applies to hardware, or biological implants.

SaMD Definition Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device

NOTES:
• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical devices.
• SaMD is capable of running on general purpose (non-medical purpose) computing platforms • “without being part of” means software not necessary for a hardware medical device to achieve its intended medical purpose;
• Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
• SaMD may be used in combination (e.g., as a module) with other products including medical devices; • SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software • Mobile apps that meet the definition above are considered SaMD.

The document herein was produced by the International Medical Device Regulators Forum
 (IMDRF), a voluntary group of medical device regulators from around the world. The document
 has been subject to consultation throughout its development.
 There are no restrictions on the reproduction, distribution or use of this document; however,
 incorporation of this document, in part or in whole, into any other document, or its translation
 into languages other than English, does not convey or represent an endorsement of any kind by
 the International Medical Device Regulators Forum.



The road to the use of software as a medical device is still new, especially to  those directed to consumers or sold as B2C.



The link here will take you to the  International Medical Device Regulators Forum  







imdrf-cons-samd-ce.pdf

Thirty-six connected health apps and devices the FDA cleared in 2016 |

Over the past year, 36 devices have received clearance from the Food and Drug Administration. 

There are ongoing significant changes for monitoring devices.  Apple is working closely with the FDA according to some email conversation Digital Health Space has obtained.


Scoop: Emails show FDA asked Apple to advise on Software as a Medical Device

Scoop: Apple emails show plans for two FDA-regulated cardiac devices

As the world’s medical device regulators work to harmonize how best to regulate software as a medical device (SaMD), MobiHealthNews  learned via a Freedom of Information Act request that the FDA invited Apple to join an international task force focused on shaping this future regulatory framework. Apple executives quietly joined a working group within the International Medical Device Regulators Forum (IMDRF), a group of regulators, scientists, legal experts and physicians from the US, Canada, the European Union, Australia, China, Russia, and Brazil to pursue harmonization of the regulatory approach to standalone medical software.

In addition to this information the International Medical Devices Forum has held meetings regarding devices, to which Apple has attended.  In the United States the FDA is represented by  
  • Bakul Patel
    US Food and Drug Administration
  • Dr. Doug Silverstein
    US Food and Drug Administration
The contestants thus far are:

Biogaming      
Dario     
Sensimed   Triggerfish     
Quell   
Trak system (male fertility measurements)       

AgaMatrix      

Temp Sitter.     
InPen and mobile app      
FreeStyle Libre Pro     
PeriCoach,    
AirStrip ONE

TytoCare      
Ellipta inhaler.     
SimpliECG,     
Lumify ultrasound system, Cardiac U/S
Clarius Mobile Health

These devices and many others are in the FDA pipeline. Many companies such as software companies are unfamiliar with the FDA device approval process.  Many are in 'sleuth mode' to avoid tipping off their competitors in the health market.

The consumer market is still hazy and most consumers do not know how to acquire information or where to purchase the devices.

Options available are:  Amazon, BestBuy, CVS, RiteAid and by prescription via an online pharmacy.

The devices may be acquired through a health plan buyer's group or Pharmacy Benefits Manager.

The investor risk is substantial, and companies are hedging their bets by entering the market gingerly




Thirty-six connected health apps and devices the FDA cleared in 2016 | MobiHealthNews

Thursday, December 29, 2016

Google Search and other Search Engines for Health Care

Are you current in health information technology and it's impact on your business. There are many sources available. A recent study reveals how MDs access information using the internet.


"GOOGLE" is now a noun as well as a verb. When one thinks about search, "Google" is the first engine which comes to mind.

Google search reveals the following when I searched for the top search engines for health.

7 Trusted Medical Journal Search Engines

Finding a medical journal search engine

Search engines are designed to integrate with an online academic database of archived published literature.
Large medical journal databases index articles from thousands of journals all across the world. Here are just a few databases commonly used by credible medical search engines:
Ovid, Science Direct and Scopus require individual subscriptions and/or       
institutional links.

The cost of some of these paywalls is very high  in many cases, and only suitable for academic research with formal research grants. They are not appropriate for individual searches.  PubMed, Medline are the most useful from personal experienc and will direct users to the source abstract and/or citation.
And of course Google Search will bring you to all of these search engines.