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Course video 68 of 123

TECH MeD: Transdisciplinary Education for Critical Hacks of Medical Devices

佛罗里达大学

This course seeks to create an informed public, aware of the technical, medical, legal, and ethical issues associated with implantable medical devices. The course features conversations with experts from a variety of relevant fields to discuss the present and future technological, ethical, legal, and social challenges associated with implantable medical devices. DISCLAIMER: This course is intended for educational purposes only. None of the information provided in this course constitutes medical or legal advice. If you have medical or legal questions, contact your physician or attorney.

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教學方

Lauren Solberg
Assistant Professor
Michael Bachmann
Associate Professor
Adam Shniderman
Assistant Professor
Molly Weinburgh
William L. & Betty F. Adams Chair of Education
Brittany Bachmann

腳本

It is already a very hard and important question,

what gets classified as a medical device as opposed to a medical service?

And that distinction, I think,is going to get blurred, and that might cause,

might be caused for regulatory reform in a bigger way,

in a more meaningful way, or at a higher level of generality that

affects more things than just wirelessly connected devices.

If robots are performing surgery is that robot a device or a service?

We're already there, basically, and the fact that our regulatory

system is based on a world that we don't live in anymore is a problem.

And so that's really the concern with all the regulation or

not thoughtful regulation that I'm worried about.

Then again, that's where I think standards make more sense than bright line rules.

No absolutely, I agree and I wouldn't want let's say that Google puts out for

sale eyeglasses that correct vision and provide other functions.

Is that a good or a service?

It seems pretty clearly to be a good, but what if on the back end,

they could provide all sorts of analytics and send you email updates about

how you're behaving and maybe make suggestive changes, right.

Now it starts to sound like a counselor and that's more like a medical service.

And I wouldn't want, if that ends up being a useful service,

I wouldn't want them not to provide it out of some fear that the regulatory system

is going to apply to them in a way that would be overburdensome.

So again, I'm not pro regulation or anti regulation in this space.

It's just a question of crafting sensible regulations that strike

the right balance between risk and

reward in an area where there's a huge amount of reward potentially, right?

There's amazing lifesaving applications for these devices, but

there are also a number of risks.

And so we have to strike the right balance in terms of entrepreneurship, in terms of

intellectual property protection, in terms of our international partners.

And I think in terms of setting the rule nationally, but also allowing people in

the individual decisions they make with the sellers of the goods that they're

buying and with their doctors, how do we structure that interaction so

that people can make meaningfully informed choices?

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