Who owns liability when a networked implant impacts patient care?
What happens to your neural data when a BCI startup goes bankrupt?
Does tort law even apply when the attacker is a nation-state?
If you work in health law, regulatory compliance, medical malpractice, or tech policy — your analysis belongs at DEF CON's Biohacking Village. Come meet them.
Submit your talk → https://forms.gle/Fp7jjtkXWDkKHwME7
#healthlaw #biocybersecurity #hospitalinfrastructure #meddevice #DEFCON
Thought experiment: What if we didn’t rush to create a new regulatory framework for #GenAI in #healthcare but simply applied existing frameworks to this new ‘flavor’ of computing?
Pros: Application of existing frameworks enhances predictability and consistency, eliminates the perception that regulatory authorities are ‘playing catch-up,’ allows for consideration of outputs and impact of different kinds of systems with less focus on the internal workings of those systems. We already have approaches to regulating ‘black box’ systems (e.g., #SaMD). Another analog to consider: Do we regulate internal combustion engines that use carburetors entirely differently from the way we regulate engines with electronic fuel injectors?
Cons: #GenerativeAI is actually completely different from everything that has come before so it can’t be regulated in the same way.
What say you? Could existing frameworks work here, or do we need a new way of doing things?
#digitalhealth #innovation #AI #medtech #healthtech #meddevice #healthit #regulation #LLM
This third recall likely worsens already poor consumer trust in Philips.
See: Lizzy Lawrence's reporting that the Philips recalls have been good for their competitors' business: https://www.statnews.com/2023/02/09/philips-cpap-resmed-recall-prosomnus/
CES is often where you’ll see cool health tech concepts, but the FDA clearance process is a hurdle that many companies don’t clear. But while most companies opt to avoid regulation, Movano Health and Valencell are two health tech companies that are trying to conquer the clearance process.
ICYMI — Patients with implants should not be left high and dry by now defunct #MedDevice mfr.
https://www.nature.com/immersive/d41586-022-03810-5/index.html
The Harlow On Healthcare Daily
-- The Companion Reader to David Harlow's #FiresideChat s with #HealthCare #Innovation Leaders on HealthcareNOW Radio https://paper.li/HarlowOnHC/1508522923?edition_id=fe81de30-6689-11ed-b9ac-fa163e1a70d7
#HarlowOnHC #digitalhealth #newsletter #HITsm #podcast *player included* #privacy #dataprivacy #HIPAA #meddevice #medtech #medicaldevice #patientexperience #healthequity
(You can enter an email 'subscription' on the webpage if you like and of course can cancel any time if you find it annoying or useless or both.)
Full disclaimer re: automated newsletter --
And remember, while I gave them some general guidelines, articles shared are selected by 100 chimpanzees working on typewriters. Eventually, they'll reproduce the collected works of William Shakespeare. But sometimes they do dumb stuff.
I’m the Chief Compliance and Privacy Officer at a #medicaldevice company. Anything you read here is shared by the algorithms/ chimpanzees and me, not by my employer.
I’ve been thinking and writing about health care, #healthpolicy, innovation, digital health, #healthdata and more for a very long time.
Finally, please pardon any ads you may run across. Some of them are really silly.
Biohacking Village
cafepharma
David Harlow
Brittany Trang
Anne Miller
