Sunday, February 12, 2017

Telemedicine and Informed Consent

Telemedicine & Informed Consent: How Informed Are You?

Telemedicine, and mobile health growth have accelerated more quickly than regulations can be written.

It used to be (back in the old days) that “doing” telemedicine (TM) was so new and foreign to everyone that it was considered research, and thus required—at most institutions—human subjects or Internal Review Board (IRB) approval. Patients had to be consented into a study prior to engaging in any sort of telemedicine encounter.
Thankfully, for the most part, those days are gone. While some institutions may still require IRB consent, that number has decreased significantly. Of course, if you are conducting a scientific experiment using a new telemedicine device or some new procedure, that study will have to go through the usual IRB approvals and involved patients will need to be consented.

This does not mean, however, that consent is gone for “every-day,” routine teleconsultations. What is generally required now is the type of informed consent that any patient signs when receiving medical care. That consent for telemedicine, however, comes in different flavors. Some states just require the standard patient consent to be seen without any additional language about telemedicine. Some require the standard consent to have additional telemedicine language—and the exact wording varies, as does the need to initial or sign in multiple places. Some states require a separate informed consent for telemedicine (often in addition to the standard consent to be seen).

Currently, 29 states include some sort of telemedicine informed consent requirement in their statutes, administrative codes and/or Medicaid policies. You should always determine in advance what the policies and requirements are for your state. The Center for Connected Health Policy (CCHP) ( and the American Telemedicine Association (ATA) ( provide overviews of current state policies.

Some basics to keep in mind, at least for an initial encounter and maybe periodically thereafter if there are additional visits, include:
  • Inform patients of their rights when receiving TM, including the right to stop or refuse treatment
  • Tell patients of their own responsibilities when receiving TM treatment
  • Have a formal complaint or grievance process to resolve potential ethical concerns or issues that might come up
  • Describe potential benefits, constraints, risks (privacy, security)
  • Inform patients of what will happen in case of technology or equipment failures during TM sessions, state contingency plan
  • Inform patients & obtain their consent when students or trainees observe the encounter
  • Obtain patient consent prior to any recording of the encounter (note that the recording will be made available upon request and that release of the recording shall require written patient authorization or court order)
  • Adhere to all applicable laws and regional and local practices as to Patient Informed Consents & Disclaimers
  • Set appropriate expectations regarding TM encounters, including, for example, prescribing policies, scope of service, communication, and follow-up
  • To reduce risk of overprescribing, follow evidence-based guidelines as well as all federal, state and local regulations
  • Have a procedure in place for patients who don’t wish to sign the consent forms or receive care via telemedicine
It is useful to periodically check the status of your state’s current laws and Medicaid policies on informed consent for telemedicine either via the CCHP, ATA or your regional Telehealth Resource Center. Your state may have specific policies on what provider types may obtain the informed consent (especially in the case of behavioral health) and what items the informed consent must include.
And even if your state doesn’t have specific rules on informed consent for telemedicine, keep in mind that informed consent not only informs and protects the patient, but also, according the MedPro Group, protects the provider from the risk of facing consent-based negligence claims.
Much of this is common sense, but every now and then it helps to remind everyone!

Elizabeth Krupinski, Ph.D. is a Professor at Emory University in the Department of Radiology & Imaging Sciences and is Vice-chair of Research.. She is Associate Director of Evaluation for the Arizona Telemedicine Program and Director of the SWTRC. She has published extensively in these areas, and has presented at conferences nationally and internationally. She is Past Chair of the SPIE Medical Imaging Conference, Past President of the American Telemedicine Association, President of the Medical Image Perception Society, and Past Chair of the Society for Imaging Informatics in Medicine. She serves on a number of editorial boards for both radiology and telemedicine journals and is the Co-Editor of the Journal of Telemedicine & Telecare.


Thursday, February 9, 2017

New study finds TytoCare telehealth exams equivalent to in-clinic exams

TytoCare is a handheld device and telehealth solution designed to capture and transmit ear, throat, lung, skin, heart and temperature exam data to a physician.

New study finds TytoCare telehealth exams equivalent to in-clinic exams
Tyto Care announced the results of a study with the Schneider Children’s Medical Center and the Sackler School of Medicine that affirms its solution’s ability to perform physical examinations on par with conventional in-clinic examination tools.
TytoCare is a handheld device and telehealth solution designed to capture and transmit ear, throat, lung, skin, heart and temperature exam data to a physician. The study was looking to evaluate the accuracy and quality of the physical examination findings reached by a remote physician using TytoCare versus physicians using conventional examination tools, including traditional otoscopes and stethoscopes.
The participants were 137 children aged 2-18 who were seeking care from the emergency department of a tertiary care facility. The study was conducted in a combined effort by Professor Yehezkel Waisman, Director of Emergency Medicine, Schneider Children's Medical Center of Israel; and Associate Professor of the Sackler School of Medicine, Tel Aviv University; and Dr. Assaf Sharabi of the Schneider Children's Medical Center.

"The results are clear — examination findings achieved with TytoCare are on par with those reached by conventional examination tools," Professor Waisman said in a statement. "Beyond that, the quality of the readings as well as the overall user experience received positive ratings from physicians, a great testament to the solution's promise to provide accurate and confident diagnoses via telehealth technology."
Patients were examined and assessed by one physician using conventional examination tools and again by a second remote physician using exam data captured by TytoCare. The two result sets were compared and analyzed using standard statistical tests for agreement. In addition, the quality of the data retrieved and the user experience of TytoCare were evaluated on a spectrum from 1 (poor) to 5 (excellent), with adverse events recorded. Results showed a range of good to excellent agreement for all exams conducted using TytoCare and conventional exam tools, with a p-value
"The proven success of TytoCare signifies a major advance in the telehealth industry," Tyto Care Founder and CEO, Dedi Gilad, said in a statement. "By providing reliable, remote examination data, TytoCare delivers 'the missing link in telehealth,’ expanding the ability of physicians to reach confident diagnoses miles away from their patients."
TytoCare has recently announced a strategic partnership with American Well, a leading telehealth technology and services company in the US.

This device has a form factor that is usable and efficient. The entire examination can be performed by changing the adapter. There are individual adapters for ear and throat exams, heart and lung, temperature, and skin images.  

Tytcocare was developed in Israel.It is not yet apparent if the company has applied for a CE, IDE or FDA clearance.

New study finds TytoCare telehealth exams equivalent to in-clinic exams

Sunday, February 5, 2017

The Bots, Who's watching Them?

This article was written for other industries, such as retail or sales organizations. However much of it’s content can be extrapolated to medicine, health and wellness and technology/

However, who watches the algos, or the bots ?

Most humans are conditioned to trust authority but what causes people to decide whether a computer is authoritative or not? That is, are we more or less likely to trust a piece of information when it comes from a computer versus from a person? Researchers continue to study this question but it’s one which may become increasingly important in a future of bots – is it a human? a computer? Will the phrasing of the response change based upon the bot’s degree of confidence in the answer? And to what extent will regulations play a role in this, especially in areas of legal or medical advice?
Rather than it being too early to start considering these questions, they’re exactly what came to my mind when reading a recent article about technology companies now hiring writers, poets and other professionals to try and figure out what communicating with a bot should feel like.
“Now she’s applying her creative talents toward building the personality of a different type of character — a virtual assistant, animated by artificial intelligence, that interacts with sick patients” the article says of one woman who used to write scripts in Hollywood.
And later in the article, “how human can — and should — the bot sound? Should the virtual assistant be purely functional or should it aspire to connect emotionally with the user?”
Should a shopping bot provide positive affirmation about the clothing items I have in my virtual shopping cart? “Oh you’ll look hotter in this,” the bot coos as it pushes a $150 sweater as an alternative to the $25 sweatshirt I was considering. Is that a lie? Doesn’t a salesperson at a store do the same thing? Is it better or worse when it’s done by a computer simultaneously to 10,000 customers?

Will multivariate testing of our bot future contain ethical parameters in addition to performance measurement? Techniques like priming can be used to dramatically impact behaviors. For example, asking you if you are a “good person” and having you answer in the affirmative, before I request something of you, increases the likelihood you’ll do what I want, driven by a need to live up to the identity you created for yourself.
My friend Anil Dash talks about the need for CS departments to teach ethics and I’ve always nodded but as we move towards a conversational, AI future maybe we’re about to see a step-function in the importance of teaching these concepts.

Monday, January 30, 2017

Are those Mobile Health Apps reliable ?

The line between pharma and health information technology is blurring. SAAD (Software as a Device) stands alongside  SAAS (Software as a Service)

The progress is punctuated by the FDA which will require vetting of health software when it is linked to treatments.  No such requirement has been proposed for electronic health records, but is now being required for mobile health applications and/or remote monitoring.

In the past the FDA (Food and Drug Administration) was responsible for the safety of food stuffs. It is also responsible for the safety and efficacy of pharmaceuticals, and medical devices.  The vetting of pharmaceuticals is complex and very expensive.  The cost of new drug development is quoted as between 450 million dollars and 900 million dollars.  Pharma uses these figures to justify the cost of new proprietary formulations. The patents are valid for 16 years.  When a new drug makes the 16 year mark it becomes available to other pharmaceutical companies to be sold as generic drugs,  and the cost drops significantly.

If and when SAAD becomes available for diagnosis and treatment some SAMD will require FDA approval. Usually this takes at least 12 to 24 months, unless there are urgent medical considerations.  I would expect a price increase for SAAS.

FDA floats new draft guidance, created by international group, on software as a medical device

Therefore it is not at all a guaranteed win.

Finally, mHealth is the winner : Software as a drug? - Health Files by Rajendra Pratap Gupta | ET HealthWorld