FDA Regulation of Mobile Health Report Released

FDA Regulation of Mobile Health

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



Developing Nations Lead the Way in mHealth

Mobile eHealth Solutions for Developing CountriesIn many markets disruptive innovation and technologies that were once the domain of developed countries with extensive University and private research networks have been overtaken and surpassed by developments in emerging markets.

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.


Healthcare To Pair Well With Bluetooth 4.0

Blue Tooth 4.0Often when we think of mobile Health we focus on mobile as in cellular devices however there is a great deal innovation taking place in other areas of this market that will have impact beyond the iPhone. Bluetooth is one of these technologies that is a rather silent but potentially huge game changer.

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.


New England Journal of Medicine iPhone App

New England Journal of Medicine iPhone App

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.


Apple Files iPhone Heart Rate Patent

Apple Heart Rate Patent
Apple has filed a patent that could be the first step in a larger plan to merge mobile and consumer health devices into the iPhone platform.

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.


GE Launches Centricity Advance EMR SaaS

GE Centricity Advantage

Leveraging the acquisition of MedPlexus, GE today announced the launch of Centricity Advanced, a SaaS EMR including physician office management with an integrated patient portal. This is an interesting release in that rather than porting an EMR from the client server world, Centricity Advance has been designed and built as a native web application and is therefore created with the web in mind, not as an afterthought.

The advantages of an EMR SaaS are wide-ranging. Rather than building, managing, upgrading and supporting their own in-house system, Physicians can leverage the new platform to offload the majority of their IT needs in exchange for a single monthly fee. The cost advantages of a $4,000 to $9,000 start up fee with monthly payments averaging $500 per month versus $20,000 upfront for in-house self-managed system provide a compelling business case. The real return on investment however is driven by freeing up time, resources and possibly office space allowing clinicians to focus on providing patient care rather than providing IT care.

Generally when things are less expensive, the price is paid in lost features or performance however GE is adamant that the system will not disappoint.  One of the main innovations worth a look is the integrated Patient Portal that will allow patients to securely access their personal medical records, schedule their own appointments, request refills, access billing statements, lab results and communicate privately with authorized clinicians.

For Physicians looking to modernize their offices or perhaps provide better means of connecting their practice with their patients but who do not want to spend a great deal of time or money upfront, SaaS may be a leverage point that offers the best possible value for money.

Resources:
Read the full news release on GE’s site here,
And an excellent summary artical on Computer World here.


4 Must Read Healthcare Social Media Articles

What do Doctor’s and Nurses really think about Social Media and it’s potential and place in Healthcare?

Here are 4 must read articles that explore the subject from a number of angles, attitudes and perspectives:

Social networking impact on patients, doctors, and non-profits
Dr. David Nash outlines effective uses of social media and the differences between mainstream sites like Facebook and healthcare focused sites such as PatientsLikeMe.

How social media can make physicians better doctors
Mike Hennessy, founder and editor of MD Net Guide explores the challenges, realities and possibilities of social media for Doctors.

Doctors who are not on Facebook, Twitter and blogs risk becoming irrelevant; my USA Today op-ed
Barbara Ficarra, RN, BSN, MPA argues that patients need Doctors online to ensure that medical information is timely and accurate. If they don’t, the information vacuum will be filled but by who and at what risk?

Social media starts the patient dialogue with doctors and nurses
Barbara Ficarra, RN, BSN, MPA explains that there is no need to apologies to your doctor or nurse for wanting to take an active role in your own well being.


Mobile Health 2010 at Stanford University

Presentations from the Mobile Health 2010 Conference at Stanford University are now available online.

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.


Study concludes CPOE saves lives

Lucile Packard Childrens Hospital at Stanford Logo.gifThe Wall Street Journal has reported that a study conducted at the Lucile Packard Children’s Hospital at Stanford concludes what many in the industry have believed for years; that the implementation of CPOE can have a meaningful and immediate result on patient outcomes.

The study found that monthly mortality rates dropped by 20% to .7 from 1 per 100 discharges. While this seems a small factor, it is estimated that 36 fewer deaths occurred over the 18 months that the CPOE system was studied after being launched which is quite material.

Resources:
Read the WSJ article here,
Access the study on the Journal of American Academy of Pediatrics site here.

Lucile Packard Children’s Hospital

Gov 2.0 meets Healthcare

On June 4th, the US Department of Health and Human Services (HHS) officially launched a public sector / private sector collaboration dubbed: The Community Health Data Initiative (CHDI). The initiative will make data sets pertaining to public health open and easily accessible.It is hoped that this will result in innovative, creative and practical uses to improve both individual and public health.

Data sets released include information on: smoking rates, obesity rates, access to healthy food, and utilization of medical services and a host of other health related data stores, all available in open and downloadable formats.

The result of the data being released has become evident almost immediately. Within the 12 weeks that HHS posted on an interim site, citizens took up the challenge and began writing apps and mashups including the following examples:

  • An interactive community health dashboard that allows civic leaders and citizens to see a “report card” of health performance in their county and learn about the latest best practices that other communities have implemented to improve their performance;
  • Integration of patient satisfaction ratings from Medicare’s Hospital Compare database into web search results for hospitals – bringing this information to your fingertips
  • Amazing new health mapping tools that help consumers, providers, and policymakers focus on the right questions and make better informed choices
  • A brilliant new combination of GPS device and app that allows asthmatics to have their inhalers automatically transmit the location and time of each use – producing an anonymized, real-time map of asthma incidence that can provide crucial guidance regarding how to target interventions to reduce the burden of asthma
  • A (highly addictive) new online card game that engages you in a discovery of your community’s health and well-being status and how it compares to other communities in a head-to-head clash
  • And more!

HHS plans to capitalize on this early success by continuing to expand the supply and release of data over the coming months.

Resources:
Read the formal White House release here,
Read the formal HHS release here,
Watch the video of the event here,
Directly access the data here.


Social Media for Candian Healthcare

John Sharp from the Cleveland Clinic was recently in Toronto to give a presentation on Social Media for Canadian Healthcare at the Toronto Academic Health Sciences Network Education Day for Healthcare Communicators .

While a good majority of the Social Media strategies that U.S. Hospitals are using are designed to attract and retain patients which is somewhat irrelevant in Canada, he does have some excellent ideas on how and what could be leveraged successfully here.

An example he explores on his blog is Social Media for Hospital Foundations.  Charged with fund raising for capital purchases, Social Media provides an excellent means of directly engaging with and staying connected with donors.

Even if not all the information translates directly to the Canadian market, it’s very interesing to see what the Cleveland Clinic is doing online. His complete presentation is embedded above and is very insightful and well organized. His blog is also a excellent source of information on the topic and he has made available additional presentations on slideshare.

Resources:
Go to the source,
John Sharpe’s Blog,
John Sharpe on slideshare.