When Robert Delano was diagnosed with early onset Parkinson’s at the mere age of 30, he was deeply unsettled by the subjective nature of his diagnosis.
Doctors would say, “You’re young and your tremor is fast”, and other observations, he explained in an interview with NPR in Atlanta “When I asked what fast is, the definition they gave me was that it’s faster than most”.
More than 10 million people in the US suffer from tremor-related disease, including Parkinson’s, essential tremor and multiple sclerosis. (Boelen, 2009) This presents a major business opportunity for a forward thinking innovator to develop a Smartphone App capable of capturing and contextualizing patient tremor data remotely in real-time for purposes of developing a truly objective and standardized diagnostic protocol.
Delano, along with his co-principal investigator Brian Parise of the George Tech Research Institute (GTRI), believes their iTrem Smartphone App is precisely such a solution.
[Ed. This is the first of a three part series examining the past & present of FDA regulation of mHealth ]
By: Felasfa Wodajo MD, Rene Quashie JD
As many of our readers know, the role of the FDA is evolving with respect to mobile medical software and devices. There is no question that the FDA has jurisdiction to regulate medical software, not to mention a responsibility. The difficulty for outside observers and software developers has been predicting what level of stringency the FDA will apply to medical apps and devices in the future.
Two well known examples of medical apps which have sought and been granted approval by the FDA are AirStrip, a cross-platform app for live fetal and ICU vital sign remote monitoring and MobileMIM, an iOS app for viewing CT & MRI images. The year long process until MIM Imaging finally obtained FDA approval in December 2010 was retold by Mark Cain, CTO of MIM Imaging, on this site, providing an insight into the challenges for both sofware developers and the FDA.
Another important recent event with regard to the FDA is the February 2011 publication of the final rule on Medical Device Data Systems (MDDS). This ruling, first offered in draft form in 2008, allows certain types of medical devices to seek approval as Class I devices, thus avoiding the more complicated involved processes required for Class II and Class III devices. Finally, on July 19, the FDA marked an important milestone by releasing a draft guidance on its intended pathway to regulation of mHealth apps.
These are important developments but what do they mean for the development of mobile medical apps ? In these three articles, we will aim to demystify the role of the FDA and seek to learn more about its past and possible future role in mobile health.
In 1994 no state in the Union contained a population of obese individuals greater than 20%. By 2009, the only state with an obesity rate under 20% was Colorado. In 2008, obesity related health care costs amounted to 9% of total spending, or $147 billion, versus $78.5 billion in 1998.
BodyMedia, has made the fight against obesity its central corporate mission. The Pittsburgh-based company has developed a patented wearable sensor device and complementary software applications that track users physical activity levels, calories expended and sleep patterns for the purpose of helping people lose weight, improve performance and lead healthier lives.
Telemedicine is quickly gaining momentum for its potential to increase access to health care while offering significant cost savings. This trend towards supplementing and replacing traditional in-person consultations with remote care, especially in the critical care setting, raises many questions. Is this technology an effective proxy for face to face medical care? How will insurers incorporate these services into their coverage? With our country in its current budget crisis, these questions are quickly becoming more and more relevant.
The CMS has recently proposed increasing its coverage of telehealth services. While Medicare has covered telemedicine dating back to 1999, it has historically used a “comparability standard” in which physicians had to prove that their specific telehealth service was equivalent to in-person care. Now, the CMS may switch to covering telehealth that has “proven clinical benefit.” This would increase the range of services eligible to be covered, and in turn could increase access to providers, especially in rural and under-served areas.
Most of the mHealth buzz centers around smartphones and tablets – wireless access to imaging and medical records, apps for evidence based practice and many other advancements that are revolutionizing developed health systems. It’s easy, however, to overlook the potential that traditional cell phones have in the context of mHealth. In rural areas and developing countries especially, health care infrastructure and access to care remain extremely limited, but SMS text messaging is quickly becoming an effective way to reach these populations. Programs to take advantage of SMS to improve health care access have recently started to gain momentum – our recent post highlights some of these campaigns in South Africa.
The American Diabetes Association (ADA) and the CDC are partnering to pilot a program that uses texting to help patients understand risk factors for diabetes and connect them with appropriate resources. People can answer a short series of lifestyle/medical and family history questions via text, and then based on their apparent risk for diabetes, they get information on clinics, physicians, or even online forums about diabetes prevention.
Being able to scan and read journal articles is integral to clinical practice and teaching. However, with so much information and new research available, sorting through the publications can be a daunting task. Even Orthopedics, considered to be a specialized field, has over 50 American publications and journals.
Dr. Jeffrey Wint, an orthopedic hand specialist in cooperation with Hand Fed developers created Bone Feed as a way for orthopedic surgeons at all levels of training to have access to abstracts from popular orthopedic journals using an iPhone. It is a good concept, but does the app perform?
By: Manoj M. Lalu, MD
“Is it safe for me to perform a regional or neuraxial procedure on this patient taking anticoagulants?”
This is a question we are often faced with in the operating room when dealing with patients taking anticoagulants. Answering this question has become increasingly difficult as both the number of anticoagulant drugs and the indications for these drugs have increased recently.
Fortunately, practice guidelines have been published by both the American Society for Regional Anesthesia and the European Society of Anaesthesiology. Unfortunately, the bulk of these documents makes it difficult to find the quick answers we often need. This is where Coagulate, an app for both the iPhone/iPod Touch and the iPad, comes in. This app was developed by LJ Cubed Apps and is a steal for 99 cents.
[Ed. This app review is part of our continuing series at iMedicalApps to find the best ECG apps]
Börm Bruckmeier Publishing LLC have published 38 i-Pocketcard applications for the iPhone, iPod and iPad. One of the most recently updated is the ECG application.
According to iTunes, ECG i-Pocketcards is described as:
- a quick reference for identifying all common ECG findings, such as hypertrophy, AV conduction defects, arryhthmias and more
- a concise summary of how to record and read an ECG and a standardized evaluation sheet
Read on to find out how it fares as a tool to help understand and evaluate ECGs.
It is estimated that in 2007, $174 billion was spent on total costs just for patients diagnosed with diabetes. With the disease prevalence on a steady incline, nearly all specialists will continue to encounter the disease in some form, whether it is an intensivist dealing with diabetic ketoacidosis, an ophthalmologist dealing with proliferative retinopathy, or a surgeon performing an amputation.
However, long-term management of diabetic patients is mainly the domain of internists, endocrinologists, and family practitioners. Treating patients with diabetes requires a broad and up to date knowledge of complex medication regimens and its many potential complications.
This is the goal of Diabetes Mellitus i-pocket by Borm Bruckmeier Publishing: to help provide clinicians with the most current recommendations. The app, for the iOS platform (iPhone and iPad versions), was created by Mount Sinai endocrinologists, Drs. Brett and Mechanick for use by physicians at all levels of training. Read below the fold to see our review of the iPhone app.
ClearPractice, makers of the popular iPad electronic health record Nimble — that we reviewed — have now launched Eden Practice. And for all those physicians who are Apple lovers, they are going after you. Eden Practice is being marketed as a comprehensive medical office solution for the Apple Mac, iPad, and iPhone — all connected via the cloud.
The desktop version was made for Safari, and runs four times faster on Safari than accessing the desktop EMR on a Windows computer with Internet Explorer.
Eden Practice will launch in September, and it will have native apps made specifically for the iPhone and iPad
(Nimble is the EMR app for the iPad that is part of the Eden Practice suite that we reviewed). Unfortunately, their iPhone app, aptly called “Fetch”, will be limited to fetching.
As with other iPad EMRs, such as Dr. Chrono, there still isn’t a good EMR solution for inputting patient data and encounters into an iPhone. I understand the 3.5 inch display isn’t conducive to storing a great deal of text, but I’m surprised that EMR developers continue to neglect that physicians would want to dictate and create patient notes on their iPhone.
Nonetheless, the Eden suite looks very exciting. We have a beta copy of Eden and we’ll be publishing a review soon.
For more information on the electronic health record, check out the ClearPractice Eden website.
Since the beginning of this year, there have been clues that the FDA will be heading toward clarification of the complex regulatory issues posed by mobile health devices and software. We have previously reported on testimony and public comments by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH) alluding to coming guidelines.
Today, the FDA finally released a detailed draft guidance of how it intends to regulate this rapidly exploding sector of mobile medical devices and software.
This is what the Emergo group, regulatory compliance consultants, has gleaned from today’s FDA press release:
The guidance focuses on mobile applications that either function as accessories to medical devices currently regulated by the FDA; transform a mobile communication device into a regulated medical device via attachments, sensors or other medical capabilities; or allow users to input patient-specific data in order to obtain patient-specific results, diagnoses or treatment recommendations for use in clinical settings.
In the same article, the Emergo Group also notes that the FDA plans to separate draft guidances on the following:
- Wireless safety issues
- Classification and submission requirements for clinical decision support software
- How quality systems apply to software
- Regulation of mobile applications that analyse or interpret data from multiple medical devices
The FDA is accepting written comments on the proposed rules for 90 days.
This is an important milestone in the maturation of mobile health and will eventually provide important guidance to mobile medical software publishers and device manufacturers. In the coming days, iMedicalApps will be publishing a three part series on the past, present and near future of of FDA regulation of mHealth.