The question that comes up in almost any deep and detailed discussion related to the emerging mHealth market is: how does or will medical device regulation apply? Sometimes it surprises people, especially outside of the industry, that this is even a consideration. Is a Doctor’s Blackberry really a “medical device”? The answer is a resounding: maybe.

The FDA in the United States is the primary focus of most of the relevant information and speculation and to date there has been very little consolidation of facts available to healthcare executives and the vendor market to review.

To fill this gap MobiHealthNews one of, if not the leading online site covering the mHealth market has published a free report entitled “FDA Regulation of Mobile Health” which covers a great deal of this ground. The report is written by Bradley Merrill Thompson who leads the Medical Device Regulatory Practice, the Clinical Trials Practice and the Connected Health Practice for law firm of Epstein Becker Green, P.C. and who clearly knows a thing or two about the subject.

What is a “Medical Device” then?

The report begins with a few definitions that provide context for further discussions as well as a little overall clarity. The definition used for a “medical device” is the FDA’s own, coming from Section 201(h) of the Federal Food, Drug, and Cosmetic Act:

… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or] intended to affect the structure or any function of the body of man or other animals.

Components and Accessories

The two other distinctions the report points out are that of a “component” and an “accessory”. Both are regulated but to different extents and as a vendor, understanding this distinction is the key to minimizing or managing the level of compliance required.

Interestingly, the difference is defined not so much by the actual equipment or technology, but rather by who is purchasing it. End users buy “accessories” while manufactures buy “components” even though for all intents in purposes the actual device may be identical this distinction governs the regulatory compliance that will need to be met.

Summary

For those with an interest in the topic the report is extremely accessible even though it covers very technical and legal subject matter. For vendors or manufactures developing products in the mHealth market, the report is a must read if nothing else to ensure that your understanding of regulatory compliance is in line with the FDAs.

Resources:
Download of read the report online at here,
And find more mHealth news and reports at MobiHealthNews

If “necessity” is the mother of all invention, then there is no greater necessity than access to quality healthcare in developing nations and it is this fact that is driving innovation at a pace that developed countries just cannot compete with.

Mobile Health solutions are not only a necessity due to long distances, lack of infrastructure and high clinician to patient ratios, but they also make the most sense in nations where the mobile phone is the key communications device for individuals, business and sometimes entire communities.

This focus on mHealth, lack of hang-ups with existing infrastructure and communications legislation and will to bridge the gap in quality care with developed nations has been the catalyst for incredible growth. So much so that it’s now worthwhile and even advisable to be looking to developing nations for simple, efficient and effect solutions to global health problems.

If this is an area of interest or you are simply looking for a great primer resource for the mHealth market than have a look at the Mobile Health Solutions for Developing Countries 2010 published by the International Telecommunication Union (a United Nations Agency).

The report is 122 information packed pages and does a great job of capturing the requirements of an emerging mHealth market, outlines the technical aspects of the infrastructure requirements and provides excellent real world examples from a diverse group of emerging and developed nations including Algeria, India, Russia, Uganda and Nepal.

Resources:
Find the complete report online and available for download here,
Visit the International Telecommunication Union site here.

When most people think of Bluetooth, they think of headsets for their mobiles however this technology can be adapted for a number of uses in Healthcare. Basically take any two devices in relatively close proximity that do, could or should exchange information and Bluetooth can provide the solution.

A brief walk through any ward in any hospital around the world would be all that is required to complete a business case for evaluation or adoption. Take note of all of the hardwired devices and imagine the benefit of removing the tangle of integrated wires from the environment; then consider the medical and other equipment that could transmit patient data directly to a nursing station, a handheld or even an EHR without all the hassles, expense and power requirements of WiFi. It’s probably a good size list.

There have been limits to the Bluetooth technology that have made it’s integration into Healthcare technology somewhat limited to date, namely battery life. The average mobile headset can last a day or maybe two on standby but drains very quickly when in active use. A four hour charge just won’t work for for a nurse on a 12 hour shift so overcoming this hurdle seems to be the key to the technologies future success.

Enter Bluetook 4. iMedicalApps has a great article on the future of this technology which outlines why Bluetooth 4 is going to be a game changer for healthcare and one of the key components is a set of standards that will see battery charges last for weeks or possibly months.

Resources:
Check out the iMedicalApps article online here,
Or for more technical details try the Bluetooth Directory here.

The New England Journal of Medicine has launched an iPhone app and judging by the reviews it’s been very well received thus far.

As Dr. Bryan Vartabedian points out on his blog 33 Charts, “the way to a doctor’s heart is through his smartphone” (perhaps doubly so for cardiologists?) and the application’s developers have certainly understood and embraced this.

Not only is this an excellent markeitng move by the Journal, it may also be a good thing for patients too. Access to Journals by clinicians  increased dramatically when they were originally ported to the web, however “webified” versions certainly do not leverage technology beyond “distribution” in most cases. Not so with this next generation of medical journals.

The integration of multimedia, pod casts and other communication and collaboration channels behind a fire-walled website limited thier accessibility and therefore effectiveness, however now Doctors can browse the Journal anywhere, download audio material to be listened to via the iPod portion of the iPhone and collaborate via social media immediatly with thier Colleagues.

This means, more clinicians keeping up-to-date, more collaboration and greater distribution of information, data and ideas.

With the advent of the iPad and other mobile technologies, it will be interesting to see how medical journals, now faced with the same challenges as other traditional media adapt, survive or become irrelevant over the coming years. Clearly, the NEJM has set the bar high for all others going forward.

Resources:

Download the app directly here,
Read a great review on 33 Charts.

It makes great business sense for Apple. Many people exercise with their iPhone whether it be jogging, walking, cycling or at the gym. With the device already attached to the person, why not extend it’s capabilities to monitor heart rates and provide other physical data that can improve workouts? Create new interactive games? Sync music to the level of activity? The opportunities are endless.

For patients living with heart conditions, the presence of a heart monitor in the form of a cellphone seems a non-invasive to an individuals lifestyle and could also involve a great deal of added services and protection. If a patient were to suffer a heart attack, could the iPhone not immediately alert a physician or even call 911?

Integrating health monitoring capability into the market leading consumer mobile health device is a shrewd move on Apple’s part and it will be interesting to see if they actually leverage such technologies in the future.

Resources:
Go straight to the patent filing here,
Read additional summaries on Medgadget  and Engadget.

The decks are simply fantastic and excellent information resources on their own, however it’s a shame that there appears to be no audio or video for any of the presentations. Perhaps that’s by design as an incentive to attend next year.

Attendees learned how today’s mobile technology can improve the health of everyday people.

What was special about this event?

Mobile Health 2010 had a precise and practical focus: We highlighted how today’s mobile technology can improve the health of everyday people. The emphasis was on what’s working to change behavior, right now.

Our speakers did not waste your time talking about unproven solutions that are “just around the corner.” And our speakers did not give sales pitches. (Too many events make these mistakes. We won’t.)

Mobile Health 2010 at Stanford was single-track. That meant everyone heard all the speakers. This improved the conversations during breaks and each panel Q&A. On top of that, each talk was short. This time constraint caused speakers to get to the point quickly. This was much appreciated by attendeest!

With Mobile Health 2010, we built on the success of our two previous events at Stanford: Mobile Persuasion and Texting4Health. These were high-quality learning experiences. These events also led to new partnerships, research, and innovations. More

Executive Director: BJ Fogg, Ph.D., Stanford
Managing Director: Tanna Drapkin, Stanford
Co-managing Director: Diane Brodalski, CDC

Resources:
View the presentations online here.

“After years of putting up with medical software that was designed without attention to the demands of a busy anesthesia provider, Drs. Truxillo and Trask decided to create a solution that fit the day-to-day work style of the end user.”

Attention to user experience and integration into the workflow of clinicians is at the core of each app. The portfolio includes: Pedi Safe, Case Logs, Drug Infusion and Instant ECG. Prices for each app range from $2.99 to $29.99 and all are available at the Apple App Store.

Resources:
Check out the apps at the source iAnesthesia,
Or check out the iAnesthesia channel on YouTube.

Pedi Safe
An advanced airway management and cardiac resuscitation app. In an emergency, healthcare providers can quickly identify a patient’s weight or Broselow color, and then Pedi Safe displays all appropriate weight based dosing, equipment sizes, and normal vital signs. An excellent reference during a code for doctors, nurses and paramedics!

Case Logs
The Case Logs anesthesia logbook makes tracking patients easier than ever. Geared specifically towards anesthesiologist, fellows, residents, CRNAs, SRNAs and anesthesia assistants, you can create, manage and total your case logs on the iPhone. The Case Logs app pairs with the CaseLog Database to provide a secure data back-up so you will never lose your cases again.

Drug Infusion
Drug Infusion was designed specifically for the ICU nurse or anesthesia provider as a quick reference to ensure accurate calculations for dose, concentration and IV rate. The app offers both weight based and non-weight based calculations with conversion flexibility. Designed by anesthesiologists, this IV Med Drip Rate Calculator is quick and easy to use in point-of-care environments.

Instant ECG
The Instant ECG iPhone App teaches the basics of electrocardiogram (ECG) electrophysiology, myocardial action potential, waveforms, intervals and segments in order to help you develop the framework needed to analyze ECGs. Our full screen high-definition movies use pattern recognition to help you learn over 30 of the most common rhythm disturbances. Instant ECG also teaches you how to distinguish between various myocardial ischemia or injury patterns on a standard 12-lead ECG. All this education is bundled into one convenient iPhone App.

Where you live: It impacts your health as much as diet and genes do, but it’s not part of your medical records. At TEDMED, Bill Davenhall shows how overlooked government geo-data (from local heart-attack rates to toxic dumpsite info) can mesh with mobile GPS apps to keep doctors in the loop. Call it “geo-medicine.”

Resources:
Go to the source TED

“Your organization needs to license Haiku and be on Epic’s Summer 2009 version and will determine the exact feature set and any applicable charges for your use of Haiku. If you are unsure whether you can use Haiku, please contact your administrative staff,” the app description advises.

Although there are close to 2,000 iPhone medical apps available via the Apple App Store the vast majority are consumer focused such as stand alone PHRs (Personal Health Records).

Epic is only the second major EHR vendor behind Allscripts-Misys to release an iPhone application in the clinical EHR market which makes this release significant and in terms of adoption rate, one to watch.

The company’s developers reported worked to pilot the app before release with the Stanford Hospital & Clinics and this level of support along with fact that there are no additional licensing costs should provide significant credibility and assist to drive overall adoption of the application.

Resources:

Go right to the source Epic System’s home page,
Have a look at some actual screen shots at App Shopper,
Track the background info on the release at The Medical Quack and Fierce Mobile Healthcare.

There is an opt in option that will allow users to share their data anonymously to Asthma researchers. Once aggregated, the information can provide real time data to Doctors which can better help them to treat patients.

It’s interesting to think of how applications like this will begin to evolve on mobile platforms and the creators of AsthmaMD have put a great deal of thought into how best to leverage the mobile platform for better outcomes.

In an e-mail posted on TechCruch by Salim Madjd one of the creators of the app outlines a few of the possibles that they are exploring:

Just imagine what might be possible now with the data we gather from this app. For example, since we have precise location of patient and the time of their asthma activity we can correlate that against local pollutant count, adverse weather changes, and different type of pollutants. Or imagine if one area in a city shows higher per capita asthma severity than the rest, we can clearly show that in a map and alert the parent of a potential pollutant by a nearby business. Or imagine this data mashed up against a real estate site. For parents or to-be parents they can also look at the asthma activity in any specific area and make more informed decisions about where they want to move.

There is also ability to better understand the effect of different medications, on age groups, gender, on managing asthma caused by different type of triggers from pollutant to exercise, etc.

We can even alert users of higher asthma chances in real time if we detect users of similar asthma history reporting asthma issues. Ultimately we could even send tweeter streams with zipcode or geocode of areas with asthma flare ups on real time. This app has the potential to make an impact on people lives unlike anything we’ve seen before and on personal level is one of the most exciting projects I’ve worked on.

Resources:

Read the release article on TechCruch,
Go right to the source AsthmaMD’s website.