Medicolegal Implications of mHealth

When there is new technology or policies implemented in medicine, physicians today generally ask three questions:

  1. Will this make taking care of patients easier, or harder? This question has a few specifics: Will it be relevant to patient care or just be another regulatory requirement I need to follow? Will this actually improve patient care or is it something else someone is trying to ‘sell’ me on?
  2. Will this take up more or less of my time? What is the learning curve?
  3. Will this increase or decrease my medicolegal liability?

While I am not an attorney nor pretend to have an expertise in malpractice law, I am discussing this from the viewpoint of an outsider and former practitioner. I do not pretend that this is an exhaustive review of the subject.  New technologies, especially mHealth which might become a predominant part of heathcare delivery, deserve to have this subject examined.  Perhaps it is premature, as the technologies are not even in the mass adoption phase. But I thought it good to just discuss on a superficial level.

When I first adopted the use of remote monitoring for cardiac rhythm devices ten years ago, one of the concerns was medicolegal liabilities.  This technology at the time was one which involved the patient actively downloading information from their implantable defibrillator with a press of a button which synched the device with a transmitter in the patient’s bedroom. This was done by scheduled download appointment, whereby the physician knew when to review the data.  The issue at that time was what if a patient downloaded information in an unscheduled fashion?  The data was ‘out there’ without being reviewed.  It was certainly a medicolegal concern.  What I designed was a contract that patients signed after implantation of the device which stipulated that they were not to download unless by appointment.  It worked well.

Some wireless health technologies transmit data without the patient knowing it.  If this involves medical data, there must be fail-safes in place to make sure that if there is information that is critical or significant, that it is brought to the attention of the provider. Such actionable alerts might be either automatically set by the manufacturer, programmable by the individual provider, or both. Other technologies involve active participation by the patient or caregiver.  For example, a medication reminder system with a text messaging platform might require the patient or caregiver to confirm that a dose of medication was taken.  What if the patient’s medication dose was changed and a reminder sent out reflecting the older dose, which was reduced because of side effects or toxicity? Or a reminder sent for a medication that was discontinued? Or no message sent for a new medication?  These have certainly been addressed in these companies’ operational policies, but need to be strictly adhered to.

What happens in the case of a device or sensor’s malfunction or recall by the manufacturer?  There will be many wireless technologies, some patients utilizing multiple products.  An easily manageable ID protocol (devices with unique traceable identifiers) needs to happen with these technologies.  If the device is just a cell phone, it is identified in the company’s data base.

Medicolegal issues increase with increasing developments in medicine whether they are practice guidelines, new medications, or new technologies.  My goal here was not to increase anxiety, but to get one thinking about other aspects of mHealth. Your thoughts?

About davidleescher

David Lee Scher, MD is Founder and Director at DLS HEALTHCARE CONSULTING, LLC, which specializes in advising digital health technology companies, their partners, investors, and clients. As a cardiac electrophysiologist and pioneer adopter of remote patient monitoring, he understood early on the challenges that the culture and landscape of healthcare present to the development and adoption of digital technologies. He is a well-respected thought leader in mobile and other digital health technologies. Scher lectures worldwide on relevant industry topics including the role of tech in Pharma, patient advocacy, standards for development and adoption, and impact on patients and healthcare systems from clinical, risk management, operational and marketing standpoints. He is a Clinical Associate Professor of Medicine at Penn State College of Medicine.
This entry was posted in Healthcare IT, malpractice law, medical devices, mHealth, mobile health, smartphone apps, technology, wireless health and tagged , , , , , , , . Bookmark the permalink.

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