By: Felasfa Wodajo, MD and Iltifat Husain, MD and Satish Misra, MD
A recent editorial piece in the Washington Times would have you believe the FDA’s desires to regulate a portion of the medical apps will be a death blow to the multitude of potential benefits offered by mobile technology.
This isn’t the first time these types of notions have been whispered and raised, and we — the editors at iMedicalApps — have decided to write a response to the original article as it speaks to many misconceptions the general public and even media have toward the FDA’s involvement with mobile medical technology. And as the leading physician voice on mobile medical technology, we thought it was important to highlight the importance of regulation in the mobile medical sector.
In the article titled “FDA’s assault on mobile technologies, New regulations could be death blow to smartphone medical apps”, the writer makes many cogent observations including the real value that mobile medical technologies and applications could offer to improve access to care and reduce costs. In addition, the possibility of monitoring patients outside the clinic and offer real-time prompts could allow for behavior modification that encourage healthier choices, in a way that even the most earnest counseling by health care professionals cannot achieve.
However, the writer also mixes up many aspects of the evolution of mobile health technologies and its regulation to justify what seems to be an ideologically driven argument that regulation intrinsically inhibits innovation.
In reality, the FDA has issued a detailed draft guidance (July 2011) that lays down markers as to what they will and will not regulate in terms of mobile medical apps. Apps that are directed at consumers and which do not offer specific medical advice are clearly exempt as are informational apps for clinicians and apps which function as pass-through entities, providing feedback from sensors without interpretation.
What the FDA is very rightly concerned about are apps that interpret information and, with little oversight, drive clinical decision making. This is both the power and danger of health information technologies. Without careful understanding of the clinical evidence underlying those clinical suggestions and documentation of robust error management and fail safe mechanisms, patients are in danger of being harmed. Here, the rapidity of mobile development — while attractive in allowing for quick iteration and innovation — could just as easily allow harm to proliferate before the cause is discovered.
The writer also included mention of FCC regulation of broadband, the creation of accountable care organizations (ACOs) in the affordable care act (ACA) and the medical device fee. It is not clear what these have to do with FDA regulation of mobile apps.
The writer, while realizing the benefits of mobile technology, does not appear to understand the very real consequences of failure — as summarized by his own example:
For example, a drug manufacturer makes a mobile app to remind patients when to take their medications and as a monitoring device for blood glucose levels for diabetics. A pharmacy benefit manager makes a mobile app to remind patients of prescription refills. These apps are convenient and provide valuable services to patients who seek to better manage their health. Importantly, the apps are cheap or free for consumers, and cost little to develop and distribute. A win for everyone, right?
Sure, a win for everyone if this process works. But what happens if the drug manufacturer’s app doesn’t work when the latest iteration of iOS or Android is released? So the patient who takes four antihypertensives two times a day because their blood pressure is difficult to control misses one dose or two doses — there are real consequences to this. The leading reason for patients presenting with hypertensive emergency is medication non compliance — hypertension that can cause end organ damage, and all it takes is missing one or two doses of their scheduled medication. So while it’s okay if your Facebook app breaks, it’s not the same situation if your medication reminder app fails.
In summary, careful regulation can often promote innovation by setting transparent common ground rules. Patient safety remains a paramount consideration for clinicians and should always be carefully considered, especially when technology is rapidly changing. Finally, the process of regulation making is difficult and slow. This is partially because the FDA (and other regulatory agencies) are bound by law to solicit comment from the public and interested parties. While the slow speed is frustrating, the process hopefully will allow more voices to be heard and to allow us to weigh the costs and benefits of adding more rules to the process.
As physicians, we practice medicine with the oft used motto — “Primum non nocere”, translated to, “First, do no harm”. As we move forward with the promises of mobile health, our primary objective should first be to cause no harm with implementations of this exciting technology.
Link: Washington Times
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No, the FDA is not assaulting mobile technology, Washington Times editorial misguided
By: Felasfa Wodajo, MD and Iltifat Husain, MD and Satish Misra, MD
A recent editorial piece in the Washington Times would have you believe the FDA’s desires to regulate a portion of the medical apps will be a death blow to the multitude of potential benefits offered by mobile technology.
This isn’t the first time these types of notions have been whispered and raised, and we — the editors at iMedicalApps — have decided to write a response to the original article as it speaks to many misconceptions the general public and even media have toward the FDA’s involvement with mobile medical technology. And as the leading physician voice on mobile medical technology, we thought it was important to highlight the importance of regulation in the mobile medical sector.
In the article titled “FDA’s assault on mobile technologies, New regulations could be death blow to smartphone medical apps”, the writer makes many cogent observations including the real value that mobile medical technologies and applications could offer to improve access to care and reduce costs. In addition, the possibility of monitoring patients outside the clinic and offer real-time prompts could allow for behavior modification that encourage healthier choices, in a way that even the most earnest counseling by health care professionals cannot achieve.
However, the writer also mixes up many aspects of the evolution of mobile health technologies and its regulation to justify what seems to be an ideologically driven argument that regulation intrinsically inhibits innovation.
In reality, the FDA has issued a detailed draft guidance (July 2011) that lays down markers as to what they will and will not regulate in terms of mobile medical apps. Apps that are directed at consumers and which do not offer specific medical advice are clearly exempt as are informational apps for clinicians and apps which function as pass-through entities, providing feedback from sensors without interpretation.
What the FDA is very rightly concerned about are apps that interpret information and, with little oversight, drive clinical decision making. This is both the power and danger of health information technologies. Without careful understanding of the clinical evidence underlying those clinical suggestions and documentation of robust error management and fail safe mechanisms, patients are in danger of being harmed. Here, the rapidity of mobile development — while attractive in allowing for quick iteration and innovation — could just as easily allow harm to proliferate before the cause is discovered.
The writer also included mention of FCC regulation of broadband, the creation of accountable care organizations (ACOs) in the affordable care act (ACA) and the medical device fee. It is not clear what these have to do with FDA regulation of mobile apps.
The writer, while realizing the benefits of mobile technology, does not appear to understand the very real consequences of failure — as summarized by his own example:
Sure, a win for everyone if this process works. But what happens if the drug manufacturer’s app doesn’t work when the latest iteration of iOS or Android is released? So the patient who takes four antihypertensives two times a day because their blood pressure is difficult to control misses one dose or two doses — there are real consequences to this. The leading reason for patients presenting with hypertensive emergency is medication non compliance — hypertension that can cause end organ damage, and all it takes is missing one or two doses of their scheduled medication. So while it’s okay if your Facebook app breaks, it’s not the same situation if your medication reminder app fails.
In summary, careful regulation can often promote innovation by setting transparent common ground rules. Patient safety remains a paramount consideration for clinicians and should always be carefully considered, especially when technology is rapidly changing. Finally, the process of regulation making is difficult and slow. This is partially because the FDA (and other regulatory agencies) are bound by law to solicit comment from the public and interested parties. While the slow speed is frustrating, the process hopefully will allow more voices to be heard and to allow us to weigh the costs and benefits of adding more rules to the process.
As physicians, we practice medicine with the oft used motto — “Primum non nocere”, translated to, “First, do no harm”. As we move forward with the promises of mobile health, our primary objective should first be to cause no harm with implementations of this exciting technology.
Link: Washington Times