Risk Insider: Jeff Driver

Hooba-Dooba! Digital Health Care Reality: Part II

By: | August 15, 2017 • 4 min read
Jeff Driver is the Chief Risk Officer- Stanford University Medical Center and the Chief Executive Officer - The Risk Authority, LLC. He can be reached at [email protected]

As discussed in Part I, digital health care use is on the rise, and while in many ways rewarding, is not without risk. At TRA Stanford, we identified cyber security, misdiagnosis, and informed consent as three pressing issues risk managers will face.

Cyber security: As medical devices are increasingly connected to the internet, hospital systems, and other medical devices, there is a higher risk of hackers collecting sensitive information, or worse, interrupting “life critical systems” that protect human life.

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In 2015, the FDA and Department of Homeland Security provided a warning that medical devices could be tampered with by hackers.  Devices, such as IV pumps, could be accessed remotely through a hospital’s network which would allow an unauthorized person to control the device and change the dosage of medication delivered to the patient.  The vulnerability is the same for digital health apps and wearables.

A variety of clinical risks may arise through the use of digital health apps.  One such concern is informed consent and the question regarding what consent means when care is supplemented through the use of digital health apps.

The risk mitigation strategies between medical devices and the devices used to transmit or receive data through digital health apps and wearables are very similar. Due diligence efforts should ensure that digital health apps are provided through HIPPA compliant platforms and appropriate security measures are in place. Some measures include, for example, a technology backbone and infrastructure to support the function, remote device integration with real-time data sharing, reporting and cross data correlation; interoperability, data analytics and big data management, and privacy and security. A thorough risk analysis of all potential vulnerabilities is indispensable.

Misdiagnosis: While rife with potential for preventative health care, many apps have been developed without being validated for diagnostic accuracy or utility using established research methods. The use of digital health apps and any technology requires an overhaul of existing processes and procedures, as well as a process to evaluate and revise workflows. The following due diligence may help mitigate operational risk related to validity and ethicality:

  1. Research whether the app does what it says its going to do. Developers should be able to provide information about testing and provide disclaimers that their apps are not medical devices and are not approved by the FDA, when applicable.
  2. Prepare the patient, practitioners and organization to utilize the digital health app.
  3. Carry out a mock trial run of a patient encounter utilizing the technology before it is actually incorporated into patient care.

Informed consent: A variety of clinical risks may arise through the use of digital health apps.  One such concern is informed consent and the question regarding what consent means when care is supplemented through the use of digital health apps.  For example, patients may be given a code to download a specific app.  When the patient downloads the app, does that mean the patient consented to the use of the app?  Of course the clinician should complete the risk and benefit conversation with the patient, but when is consent complete?

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Clinicians should follow existing guidelines for informed consent and revise the process as necessary to conform with the unique nature of incorporating technology into patient care.  There are multiple criteria for informed consent that are applicable to this process, such as:

  1. Evaluating and documenting the patient’s competence to understand and to decide.
  2. Voluntary decision-making.  This is important because the patient should not be coerced into using this technology if he/she does not want to.
  3. Disclosure of material information is a key component of the consent process. It should be clear to the patient how the information gathered will be used in their treatment plan.
  4. The patient should expressly, in writing, authorize the plan.  The plan should include when and how the patient should access the digital health app, and a process should be in place to follow-up with the patient to determine whether the patient has accessed the app at the designated time and whether the patient has been able to utilize the app as intended.

Digital health apps will quickly become a regularly used tool to complement existing patient care practices.  There are many upsides to the risk, including more expeditious care through transmitting information in real-time, greater patient satisfaction, greater practitioner satisfaction, chronic disease management, and opportunity for competitive advantage. There are potential risks, too, but these risks can be effectively managed when proactively identified.

More from Risk & Insurance

More from Risk & Insurance

2018 Most Dangerous Emerging Risks

Emerging Multipliers

It’s not that these risks are new; it’s that they’re coming at you at a volume and rate you never imagined before.
By: | April 9, 2018 • 3 min read

Underwriters have plenty to worry about, but there is one word that perhaps rattles them more than any other word. That word is aggregation.

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Aggregation, in the transferred or covered risk usage, represents the multiplying potential of a risk. For examples, we can look back to the asbestos claims that did so much damage to Lloyds’ of London names and syndicates in the mid-1990s.

More recently, underwriters expressed fears about the aggregation of risk from lawsuits by football players at various levels of the sport. Players, from Pee Wee on up to the NFL, claim to have suffered irreversible brain damage from hits to the head.

That risk scenario has yet to fully play out — it will be decades in doing so — but it is already producing claims in the billions.

This year’s edition of our national-award winning coverage of the Most Dangerous Emerging Risks focuses on risks that have always existed. The emergent — and more dangerous — piece to the puzzle is that these risks are now super-charged with risk multipliers.

Take reputational risk, for example. Businesses and individuals that were sharply managed have always protected their reputations fiercely. In days past, a lapse in ethics or morals could be extremely damaging to one’s reputation, but it might take days, weeks, even years of work by newspaper reporters, idle gossips or political enemies to dig it out and make it public.

Brand new technologies, brand new commercial covers. It all works well; until it doesn’t.

These days, the speed at which Internet connectedness and social media can spread information makes reputational risk an existential threat. Information that can stop a glittering career dead in its tracks can be shared by millions with a casual, thoughtless tap or swipe on their smartphones.

Aggregation of uninsured risk is another area of focus of our Most Dangerous Emerging Risks (MDER) coverage.

The beauty of the insurance model is that the business expands to cover personal and commercial risks as the world expands. The more cars on the planet, the more car insurance to sell.

The more people, the more life insurance. Brand new technologies, brand new commercial covers. It all works well; until it doesn’t.

As Risk & Insurance® associate editor Michelle Kerr and her sources point out, growing populations and rising property values, combined with an increase in high-severity catastrophes, threaten to push the insurance coverage gap to critical levels.

This aggregation of uninsured value got a recent proof in CAT-filled 2017. The global tally for natural disaster losses in 2017 was $330 billion; 60 percent of it was uninsured.

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This uninsured gap threatens to place unsustainable pressure on public resources and hamstring society’s ability to respond to natural disasters, which show no sign of slowing down or tempering.

A related threat, the combination of a failing infrastructure and increasing storm severity, marks our third MDER. This MDER looks at the largely uninsurable risk of business interruption that results not from damage to your property or your suppliers’ property, but to publicly maintained infrastructure that provides ingress and egress to your property. It’s a danger coming into shape more and more frequently.

As always, our goal in writing about these threats is not to engage in fear mongering. It’s to initiate and expand a dialogue that can hopefully result in better planning and mitigation, saving the lives and limbs of businesses here and around the world.

2018 Most Dangerous Emerging Risks

Critical Coverage Gap

Growing populations and rising property values, combined with an increase in high-severity catastrophes, are pushing the insurance protection gap to a critical level.

Climate Change as a Business Interruption Multiplier

Crumbling roads and bridges isolate companies and trigger business interruption losses.

 

Reputation’s Existential Threat

Social media — the very tool used to connect people in an instant — can threaten a business’s reputation just as quickly.

 

AI as a Risk Multiplier

AI has potential, but it comes with risks. Mitigating these risks helps insurers and insureds alike, enabling advances in almost every field.

 

Dan Reynolds is editor-in-chief of Risk & Insurance. He can be reached at [email protected]