Adoption of mHealth: Can we see the Forest through the Trees?

Posted on May 27, 2012 by

In previous posts, I have highlighted many drivers and stakeholders (patient advocates, healthcare providers, insurers, hospitals, Pharma, and others) as key to the success of the adoption of digital health technologies (. There was a recently proposed amendment to the MDUFA (Medical Device User Fee Act) which places a moratorium on the publication of the FDA’s guidance on the use of mobile medical apps. The mHealth coalition responded with a letter to Senator Harkin, the Chairman of the Committee on Health, Education, Welfare, and Pensions, urging the publication of the guidance document. The bill was passed by the Senate and is expected to pass the House vote. I have expressed my reasons for which I believe that medical apps require FDA oversight. Does the FDA think this is going to fix itself or wish that the industry just go away?

I believe that this action will result in mHealth technologies gaining more footing via consumer tools and apps than on patient, transition, and outpatient monitoring and management ones. While the engagement of people in wellness is not a bad thing, the biggest impact of these technologies is the potential for improvement of healthcare delivery. Development of creative innovation will be slowed and driven overseas. It leaves hospitals and providers with possibly less secure ways of utilizing apps, while paradoxically having the government overregulate the industry until guidelines are furnished.

So the forest is the vision of how mHealth technology and other digital technologies can disrupt in a meaningful way the healthcare system. The trees are the regulatory, reimbursement, and some legal/security issues. Politicians need the help of clinicians and not just telecom companies and others in the industry to convey how important this issue is. They respond to personal stories which hit home and remind them that they too are patients and caregivers. Burying heads in the sand is not going to cut it regarding this issue. Rulings and guidelines need to be rolled out. Politics and amendments should have no place in such important issues regarding the FDA.

Posted in digital health, Election 2012, FDA, health insurance, Healthcare IT, healthcare reform, media coverage, medical apps, medical devices, mHealth, mobile health, pharma, politics, technology, wireless health | Tagged , , , , , , , , , , | Leave a comment

Why Younger Physicians Will Drive mHealth Adoption

Posted on May 17, 2012 by

“Generation C” has recently been defined by Nielsen as adults between 18 and 34 years old, who are entrenched in digital technologies.  They are indeed the Connected Generation and use technology by choice in all facets of life. It is part of their fabric.  Those entering the field of medicine would logically desire and expect to carry that over to their professional lives.  However, there are multiple barriers to the continuity of this facet of their personal lives to their professional ones as they embark on what is perceived as an otherwise high-tech journey into the healthcare world.  What are found are  EHRs which are often not intuitive, high pressurized short patient visits involving complex medical issues and a system in which connectivity is an adversarial roadblock among commercial technology companies rather than an opportunity for better patient care. Young physicians are met with teachers and mentors experiencing burnout (it is estimated that 75% of all physicians today experience burnout) and bitterness fueled by regulatory pressures and the resulting decreased face time with patients. The healthcare system itself has not yet embraced social media, medical apps, remote patient monitoring, telehealth, or informatics as significant tools.  IT (EHRs) has been adopted primarily because of mandates and financial incentives, not due to an inherent appreciation for the technology itself, yet surveys show that younger physicians adopt EHRs at a greater rate than older physicians.

Young physicians will spearhead the use of mHealth technologies for a few reasons.  The BYOD (bring your own device) to the healthcare workplace with use of these devices is greater among young physicians.   They are more engaged in social media than older physicians. Mobile health technologies are discussed more in social and online media (utilized more by younger physicians) than mainstream media. In a recent survey by Jackson and Coker of Physicians in the UK, younger ones (graduating medical school in 2000 and later) were almost 50% more likely to appreciate the value of medical apps than older ones (graduating between 1960 and 1985).   Social media represent a vast opportunity for physicians to adopt mHealth technologies.  Most physicians use social media for personal use, but professional use has lagged behind. This is in part due to physicians being unaware of the positive aspects of social media of as well as hesitancy because of potential pitfalls.  The AMA has recently established and published professional guidelines in the use of social media.   Social media and medicine will be the topic of a few upcoming posts on this site. Social media is a place where mHealth technologies are a hot topic and therefore more prone to be seen, reviewed, and appreciated by younger physicians.  While medicine changes slowly with regards to adoption of new treatments and technology, younger physicians today are taking more initiative in affecting positive changes in the arena.  I look forward to having them become champions of technology which will be more efficient and less complex tools to engage, diagnose, and treat their patients.

Posted in digital health, education, Healthcare IT, mHealth, mobile health, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , | 2 Comments

The Medical App is a Patient Advocacy Tool

Posted on May 8, 2012 by

In his book ‘The Creative Destruction of Medicine’, Dr. Eric Topol highlights a few areas important to the transformation of medicine; wireless sensors, genomics, information systems, mobile connectivity, the Internet, social networking, and computing power.  I believe that all of these sectors have significant utility in patient advocacy.  I will discuss the medical app as a patient advocacy tool insomuch as it represents a convergence of many of these areas in some finished products.

The merits of wireless sensors, genomics, social networking, and computer power have been discussed elsewhere with regards to their potential for benefit to patients, many of which are incorporated directly or indirectly into a medical app. Though benefitting patients, these apps may or may not be seen as patient advocacy tools. However, apps may benefit patients in ways which are not direct and which involve support of the patient by supporting a caregiver. In a previous post, I discussed the pivotal role of the caregiver as an important focus of mHealth.  Medical apps will become  an important focus of mHealth, and thus a tool of the caregiver and other patient advocates.

In its simplest terms, patient advocacy “regards any activity which ultimately benefits a patient. Using that definition, it can apply to care giving for an individual patient, to groups that develop policies and advice that help patients, to government groups that develop legislation to improve systems or processes for patients” (Trisha Torrey). I won’t go into specific apps, but their role in general as applied to patient advocacy.  The most common types of patient advocates are family members, friends, non-profits, and professional advocacy companies.

Apps supporting advocates may cover educational, social and financial aspects of care offering advice, references, and EHR and patient monitoring portals for caregivers.  Any app which offers a portal available to a caregiver should be seen as a patient advocacy tool, for it recognizes the importance of the caregiver role. There have been more than a few ‘five best or ten best medical apps for caregivers’.  Among these, there is a spectrum from those benefitting solely the patient to one I saw benefiting only the caregiver (Angry Birds).  There is no ideal caregiver app.  The focus of the app may be on the patient, with a portal for the caregiver to monitor progress of the patient, or on the caregiver.  A caregiver-focused app might provide support related to the navigation of the healthcare system or in direct support of the caregiver’s daily tasks or well-being.   Regardless of the scope of the app, if it generates meaningful support of the caregiver (which ultimately benefits the patient), it is a patient advocacy tool.

Whether apps contain SMS text messaging programs, simple or more complex medical tool apps, video conferencing, or remote patient monitoring, they should all consider the caregiver as an either the user or co-user of the technology.  If that is done, one need not go back to the drawing board to realize complete success.   I would hope that any medical app has as its mission to be a patient advocacy tool.

Posted in digital health, Healthcare IT, medical apps, medical devices, mHealth, pharma, technology, telehealth, wireless health | Tagged , , , , , , , , , , , , , , | 2 Comments

Medical Apps Use Gaining Support by Providers

Posted on May 2, 2012 by

There have been some significant developments and noteworthy observations which are creating an atmosphere conducive to the institution of medical apps into widespread use.

On the nursing front, a recent nursing survey which included almost 4000 nurses and nursing students revealed that 71% of nurses use their smart phones for work and 66% of students use it for school. 85% of both nurses and students said they desired an app version of a 2013 drug handbook. In addition, computer tablets have become mandatory for some nursing schools as reported in a New York Times article.

It has already been reported that 85% of physicians have smart phones, and many use them for work-related purposes. More specifically, another survey from the UK has recently shown that the value of mobile apps is more highly appreciated by younger physicians (65% of those graduating in 2000 or later) than older ones (48% of those graduating between 1960 and 1985). In the USA, 40% of emergency physicians and over 30% of cardiologists, urologists, nephrologists, dermatologists, gastroenterologists use medical apps (Jackson and Coker survey, 2011)

This adoption readiness and desire to use medical apps as tools for education and patient support is key to widespread use. Patients will in an overwhelmingly fashion use medical apps if their providers recommend them. Sure, older patients need access and education about technology. However, caregivers will be more than willing to monitor and help patients with this in order to improve their own efficiency, gain more firsthand knowledge about the patient’s medical progress and both coordinate and follow the care among providers. Coordination of care with emphasis on sharing data pertaining to medications, appointments, care instructions and remote monitoring is probably the essence of the potential worth of medical apps.

The importance of providers’ interest and initiative in the use of medical apps has profound repercussions. They are the ones who would push the hospitals to adopt hospital app stores and platforms. This in turn will hopefully lead to BYOD (bring your own device) policies and improve IT security standards. Hospitals will start adopting apps which improve their own efficiency and surveillance. Administrators, nurse coordinators, and others will utilize them. So the term ‘medical app’ has implications for operations, education (administrative, provider, patient, caregiver), as well as patient monitoring and care.

The interest that is gaining in medical apps by providers is the first wave of adoption coinciding with the interest by consumers in general to push apps into mainstream healthcare. There will be a Darwinian selection process of the best apps (assisted with third-party evaluators Happtique, Johns Hopkins Univ School of Medicine and others) and then development of future generation improved products and platforms. But the undeniable interest and growing adoption of medical apps by providers and consumers alike, the front line of healthcare, is something which is encouraging and sustainable. I look forward to their downstream effects.

Posted in FDA, Healthcare IT, informatics, IT security, mHealth, mobile health, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , , , | 1 Comment

Can an EHR Save Your Life?

Posted on April 27, 2012 by

    Every year it is estimated that 400,000 people die of sudden cardiac arrest (SCA), the number one cause of death, in the USA.   There are usually no warning signs or symptoms. This is different than a heart attack, a result of cholesterol buildup which then cracks and causes a clot formation, leading to a clogged artery and subsequent dead heart muscle portion. One might therefore characterize a heart attack as a ‘plumbing’ problem.  Sudden cardiac arrest, in contrast, is an ‘electrical’ problem.  It is sudden, as the name suggests, and is actually a very rapid chaotic electric rhythm, which, if not treated with a shock from a defibrillator, will result in death in a few short minutes.

Clinical studies have shown that people at highest risk of SCA may be identified by simple non-invasive tests done at the office of a cardiologist.  Most patients who experience SCA have prior heart damage and a decrease pumping function, called the ejection fraction, or EF.  Studies show that the best numerical indicator of an increased risk of SCA we have to date (though it does need to be taken in context of other issues) is an EF of less than or equal to 35% (normal being greater than 55%).  The cause of a low EF is usually a prior heart attack or weakened heart muscle from a variety of causes, sometimes unknown.  All patients with a history of a heart attack or congestive heart failure (CHF) should know what their EF is.  A patient with a low EF should have a referral to a cardiac electrophysiologist (a cardiologist with specialty training in the evaluation and treatment of heart rhythm disorders) for consideration of implantation of an implantable cardioverter defibrillator (ICD).

So how does this relate to digital health technology and an EHR? The EF, once determined commonly by way of a sonogram of the heart (echocardiogram) or nuclear stress test should be recorded in the EHR. Therefore, with a diagnosis of CAD (coronary artery disease) or CHF cited in the primary or secondary diagnoses of the EHR’s ‘front page’, the EF should be either affixed next to the diagnosis or linked to it.  Some EHRs can readily be mined for the information.  A clinical decision support tool for patients with a low EF could be implemented, suggesting referral to a cardiologist or electrophysiologist for consideration of an ICD.  With paper charts, the diagnostic tests to determine an EF might not be sought after or difficult to locate (especially if performed by a specialist, outside lab, or hospital).  The EHR might be programmed to deliver a ‘tickler’ to obtain an EF measurement if a new pertinent diagnosis is entered. In this way, the EHR may act as both an informational organizer and decision support tool for either a primary care physician or cardiologist to not lose sight of the potential increased risk of SCA of a patient.  Clinical decision support tools like this are reasons why Meaningful Use is extremely meaningful, especially if it is YOUR loved one’s life at stake. In addition, patient portals containing this information will be useful if public awareness campaigns about sudden cardiac arrest are combined with progress in portal access. A single click of a tablet screen may save a patient’s life!  For more information, see http://www.hrsonline.org/PatientInfo/HeartRhythmDisorders/SCA/index.cfm).

Posted in Implantable Defibrillators, medical devices, mHealth, sudden cardiac arrest, technology, telehealth, wireless health | Tagged , , , , , , , | Leave a comment

mHeath Apps Prescribing Will Change Health Care

Posted on April 25, 2012 by

There are over 15,000 medical apps available, many with patient management programs and tools.   The mHealth industry is envisioning these apps to become integral parts of healthcare practice, being touted to improve efficiency, decrease medical errors, and improve patient outcomes. If the apps are going to have the opportunity to do all this, certain initiatives need to be undertaken.

Educating both the public and health care providers about the existence, importance, and role of these types of apps and their ‘prescribability’ is necessary for widespread adoption to take place. Awareness campaigns by payers, the industry, telecommunications companies, governmental agencies, and professional health care organizations (medical specialty societies, patient advocacy groups, and non-profits) will undoubtedly contribute to the effort.

Getting the apps to patients and even more importantly, getting the most appropriate apps to patients will be an important goal.  Connectivity will initially be an obstacle with some wireless environments.  However, open architectures and institutional app ‘stores’ will be common solutions to this problem.  Informatics-guided clinical decision tools will recommend personalized app programs (one or a combination of apps) for a given patient. A hospital knowledge officer or the patient’s physician might then oversee and either approve or amend the program before it is prescribed.  Technology will allow the provider to electronically prescribe the app as a prescription, much like a medication.  The app might be emailed, or delivered in another electronic form.  One could also see that an e-prescription of an app would automatically go to the app owner to deliver any necessary hardware to the patient’s home.

I think that the most exciting aspects of prescribing apps will be the possibility of personalized prescriptions based on mining the patient’s clinical data found in the EHR, as well as the automaticity of the process itself, from prescribing to monitoring or wireless provider-patient interactions.  Prescribing apps at points of care (office, hospital, other outpatient facility) will, in my opinion, become the way in which these apps will gain the most acceptance.  The Department of Health in England has recommended 500 apps to general practitioners to prescribe to patients (http://www.telegraph.co.uk/health/healthnews/9097647/Doctors-told-to-prescribe-smartphone-apps-to-patients.html).  Efforts such as this will promote the use of the technology.

Of course, patient adherence is a concern.  The download must be completed.  The ancillary equipment, if required will need to be set up.  Patients or caregivers must comply with active data entry or messaging.  Actionable alerts, if programmable need to be adjusted and fixed by the provider. While the automated technology involved with prescribed apps make the process easy, there are still human aspects which are required.  Hopefully technology will never replace that side of health care.

 

 

Posted in digital health, informatics, mHealth, mobile health, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , | 1 Comment

Is Telemedicine Good or Bad For Us?

Posted on April 21, 2012 by

Telemedicine, as defined by the American Telemedicine Association is: “the use of medical information exchanged from one site to another via electronic communications to improve patients’ health status.”   Multiple factors are driving the attraction of telemedicine.  The ACA paving the way for millions of previously uninsured people to possibly be covered (pending the SCOTUS decision), the aging of the population with baby boomers hitting the Medicare eligible age, incentives for healthcare cost decreasing initiatives, and the economic stimulus package of 2009 earmarking money to increase bandwidth for rural telemedicine technologies. In addition, advances in technology itself as well as increased connectivity are easing the advancement of telemedicine.  Telemedicine is a part of wireless health technologies which, in concert with digital and mobile technologies will transform the diagnosis and treatment of disease as well as the healthcare experience as a whole.

Whenever new technologies and paradigms in healthcare or business are introduced, there is invariably an abundance of enthusiasm by their developers, authors, and cheerleaders.  As always, the proof of success is in the pudding.  In science, one would like to see clinical studies to evaluate the success of a diagnostic or therapeutic test or treatment both before and after adoption.  There has been attention focused in the past few years about clinical trials which are not published because of unanticipated neutral or negative results.  The suppression of the data has usually been at the request of the study sponsor, a drug or device company.  This led to the mandate of registering studies with the NIH registry of clinical trials (see clinicaltrials.gov).

Recently there have been a few clinical trials involving telemedicine which have presented conflicting results.  In February, a study performed by Geisinger Medical Center in PA demonstrated a 44% reduction in rehospitalization rates utilizing a combination of Bluetooth-enabled scales, interactive voice response (IVR) messaging, and alert-prompted interventions with telephone calls from nurses or physician visits.  The study of over 900 patients was performed over two years and initially involved patients with congestive heart failure, but expanded to include hypertension and diabetes (http://www.healthcareitnews.com/news/remote-monitoring-helps-geisinger-cut-readmissions). Another study just recently released in a preliminary online version, of 205 elderly patients with ’multiple health issues’, did not show any differences in a primary composite endpoint of readmissions and emergency department visits.  What was interesting was that a substantial increase in mortality (14.7% vs 3.9%).  There is much information yet to be made public about the study. However, one might theorize that telemedicine might have prompted increased interventions which themselves contributed to the increased mortality (see http://archinte.ama-assn.org/cgi/content/abstract/archinternmed.2012.256v1?ijkey=6b464ac6a47c35147339c60f065a490841e0b0e6&keytype2=tf_ipsecsha).

So what does all this mean? Is telemedicine good or bad? Is it good for some types of patients and not others? Is there a difference among the many types of technologies? Are results more closely related to how the data is managed rather than how it is collected? All of these questions are pertinent.  There are a few points to make.  Firstly, clinical studies are important.  Negative outcome results provide as much and sometimes more revealing information than positive outcome studies. The more patients are enrolled and the longer the follow-up, the more meaningful the data might be.  Secondly, one must compare methods including types of patients, technologies utilized, endpoints, length of follow-up, and whether the study is commercially sponsored or not. Interestingly, there have been thousands of telemedicine studies to date. We might learn from going back to many of those instead of highlighting and creating policies from a few current ones (http://www.medetel.eu/download/2010/parallel_sessions/presentation/day2/The_Evidence_for_Telemedicine.pdf).

Posted in clinical trials, healthcare economics, Healthcare IT, healthcare reform, media coverage, mHealth, mobile health, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , | Leave a comment

Is mHealth the American Bandstand of the 21st Century?

Posted on April 20, 2012 by

The recent death of American music and pop culture icon Dick Clark made me think about how his television show which began in 1957 is similar to mHealth. It initially introduced a type of music, rock and roll, via live performances of the up and coming stars of the day. Rock and roll was rapidly becoming the rage of music for teens. Dick Clark had Elvis and Chubby (no surname necessary), and subsequently Madonna as demonstration projects for the masses, beyond the young crowd. The show did not invent music nor claim to do so. It redefined how it was marketed and accepted. Mobile health technologies, likewise, will not invent but redefine health care.
American Bandstand (AB) presented music types and artists that had just shortly before caught on with young people. It was an outlet for the expression of generational independence and a self-expression. It was a place where one did not need to hold a dance partner and gyrate to the music on television without being self-conscious. How liberating. Who would’ve thought that music would get ‘points’ for having a good beat to dance to independent of its lyrics or melody? Mobile health is one facet of the impact of mobile technologies on our society. There is now what is known as ‘the mobile generation’, a sector of the population which does not use desktop computers. (See http://newlearninginstitute.org/film-series/a-21st-century-education/technology-and-21st-century-learning). Younger people are the predominant adopters of direct to consumer fitness and wellness apps. They are more likely to have smart phones and to use the internet to research health-related issues. However, significant strides are seen in the diffusion of mHealth technology use among older people.
AB was the stimulus for many changes in music. It was both influenced by and influenced changes in popularity of various genres of music. Many types of music showcased there did not fit into a neat marketing label and created a sense of individuality for many until Madison Avenue finally commercialized it. Mobile health technologies are being developed in response to needs of the health care marketplace, but are also changing the way in which providers will approach the delivery of care. They will redefine medicine in terms of personalized approaches to diagnosis and treatment.
Rock and roll showcased on AB was developed out of the love musicians had for the new expressive freedom intuitive in the music. It encompassed many cultures and influences. One need only to think about the introduction of Santana‘s Latin or Bob Marley’s reggae influences to America’s youth. The show broke down racial and cultural barriers. mHealth will hopefully decrease digital and health care divides (see http://davidleescher.com/2012/01/10/decreasing-digital-and-health-divides/).
Music is an integral part of my soul. So is my passion for digital health technologies. So it was natural to put Dick Clark’s passing in terms of what AB was to music and its analogy to mHealth. Comments?

Posted in digital health, education, healthcare reform, mHealth, mobile health, music, technology, telehealth, wireless health | Tagged , , , , , , , , , | 2 Comments

Can Digital Health Technologies make People Better Health Care Consumers?

Posted on April 17, 2012 by

By now, many have either heard Dr. Jon Cohen’s talk firsthand or read articles referring to it. Dr. Cohen, CMO of Quest Diagnostics was a speaker at the recent TEDMed conference where he commented on how poorly educated and motivated people were as consumers of health care compared to other goods and services. I will not review the talk itself, but will refer you to a couple of other pieces which do: http://mhealthinsight.com/2012/04/14/do-patients-make-poor-health-care-consumers-or-does-a-lack-of-documentation-just-make-choices-too-difficult/ and http://healthbeat.areavoices.com/2012/04/16/undermining-the-patient/. What I would like to do is to discuss how digital health technologies may improve consumer education when it comes to health care. As a matter of disclosure I have no financial interest in any of the companies mentioned below.
There are apps which assist in informing people of the price of care. LowestMed is designed to allow consumers to locate the cheapest price of a medication within ten miles utilizing their smart phone’s GPS feature, or expand the search by inserting a zip code. GoodRX is another comparative drug price shopping app. Canopy Financial has an iPhone app, available May 18, which is aimed at people with high deductible health insurance plans. It claims to provide an average price of a medical procedure in their local area or searchable via zip code. Prices are estimated from Medicare prices and the company’s own health insurance clients, so they are estimates at best, but do provide both ballpark figures and comparative data. Various health insurers have apps which allow people to shop for personalized health plans.
There are thousands of fitness and patient education apps. These apps, by providing disease awareness, help people seek appropriate providers, ask more targeted questions, and ultimately participate in more high level shared decision-making. Some of the more elaborate and focused education tools are Emmi Solutions (which are specifically provider-prescribed, and Orca Health. The British National Health Service has an app called NHS Direct which allows the user to check symptoms and get advice on how to relieve them, often without seeing a provider. Without having access to the app and evaluating it, I won’t comment on the merits or pitfalls of such an app.
Not all apps need to be focused on the patient. Caregivers are important health care consumers and the efforts they put forth on behalf of their patients and loved ones may be very dependent upon their consumer education. One reference for 12 handy apps for caregivers may be found at: http://www.care2.com/greenliving/12-handy-apps-for-caregivers.html.
Patient portals are portions of the electronic health record to which patients themselves have direct access to and can contribute to and amend. The utilization of these portals (albeit only by 10% of patients initially) is mandated in Stage 2 of Meaningful Use EHR mandates. There has been substantial pushback by physicians over this requirement, because of their lack of confidence in consumer motivation, healthcare literacy level, and compliance. Consumer and patient advocates are pushing hard for maintaining this standard because of its importance in the participatory medicine movement. I believe that patients will become more educated consumers of health care by being more knowledgeable about their diagnoses, medications, and medical history. They are the most invested in the success of this portion of the EHR mandate.
I am confident that people will become better consumers of health care. They simply must. Health care institutions and providers likewise need to become better consumers of goods and services, and most of all need to realize that patients should be the focus and beneficiaries first and foremost of the economic decisions which they make.

Posted in digital health, education, FDA, healthcare economics, Healthcare IT, healthcare reform, informatics, mHealth, mobile health, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , | Leave a comment

Medical Device Recalls: Implications for Digital Health Technologies

Posted on April 12, 2012 by

Everyone has heard of a recall of a consumer product such as a component of an automobile, child’s toy, or an over the counter medication. A recall of those types of products often implies taking them off the market as well as replacement or repair (in the case of device or car components). During my 20 years as a practicing cardiac electrophysiologist, I witnessed firsthand the evolution of how implanted medical device ‘recalls’ are viewed and dealt with by industry, the FDA, lawyers, physicians, and patients. Specifically, I experienced a few major ‘recalls’ of implantable cardioverter defibrillators (ICDs) and pacemakers. The companies at that time left it up to physicians to inform patients. Unfortunately, the public found out from mass media before physicians were even informed by the device manufacturers. Physicians received little in the way of guidelines from either companies or the FDA with regards to managing affected patients. Today, much is different. There are both professional and FDA guidelines on how physicians approach many ‘recalls.’ We have learned both to create registries of affected patients and to use remote patient monitoring to more rapidly and completely identify the problem at hand. The word ‘recall’ is not appropriate in most circumstances, and the term ‘advisory’ is used. This is because most advisories do not necessitate the removal of the device or component. It unnecessarily makes the issue a black and white one, conjuring up a lone solution consisting of device replacement. In fact, most advisories are today solved with device software reprogramming. There is currently an ICD advisory which has evolved into a public relations battle being fought in the mass media. I believe that advisories, like the manufacturing of the device itself, should focus on the patients themselves. The sensationalism only decreases confidence in the entire industry and might result in fewer people choosing to avail themselves of lifesaving technology, creating potentially more harm than that done by the recalled product.
So how does this tie in to digital health technologies? Firstly, it must be said that advisories or recalls affect an extremely small segment of most devices. Device advisories and recalls will occur with mHealth technologies as well. These devices are not 100% immune to defects. Most defects when they do occur, affect components which are not critical. Some will affect direct to consumer types of devices, which would translate into a voucher for refund or replacement. Others, however, will be of a potentially more significant nature, possibly affecting the accuracy of remote patient monitoring data (though in over 12 years of remote patient monitoring of ICDs no significant defects have been seen regarding the monitoring capabilities itself) or technical glitches possibly resulting in wrong advice being given. It is when we get into the more sci-fi types of technologies where defects may affect patients more. Implantable monitors, drug or DNA transporters or monitors injected into the bloodstream, or artificial type skin with sensors, where an advisory or recall approaches new territory. The FDA is moving to tighten post-market surveillance of implantable devices, in part with the institution of a unique device identifier (UDI) system (see http://blog.medicaldesign.com/perspectives/2012/03/15/bill-focuses-on-udi-system-to-ensure-patient-safety-improve-fda-oversight-of-devices/). I believe that mHealth products will be able to be tracked much easier than by UDIs by virtue of their own technologies’ tools. Quality control of mHealth should not be any different from other medical devices, and should therefore fall under the auspices of the FDA (see http://davidleescher.com/2012/02/14/five-reasons-why-digital-health-technologies-need-fda-oversight/).

Posted in digital health, FDA, healthcare reform, Implantable Defibrillators, medical devices, mobile health, technology, wireless health | Tagged , , , , , , , , | 6 Comments