Karen Boyd, ASQ CQA A double-edged sword IMO, and I see that the FDA agrees it is a growing opportunity / risk, whereby the risk-to-benefit ratio should be weighed and the onus is on all stakeholders to properly mitigate and manage medical apps against cybersecurity threats. http://www.fda.gov/MedicalDevices/DigitalHealth/ucm373213.htm

Sean McGee Joanne and Karen, thanks for your comments.
I think that the FDA and other regulatory bodies may need to allocate a greater share of their efforts towards consumer education, so that the consumer starts to help support the regulatory agencies in their efforts to control the market. Thanks

Sean McGee Joanne,

Good point re eBay. While they are only the distribution channel for many medical devices, I do think that they have some responsibility for the distribution of unregulated devices. I wonder in time will such distributors be tasked with implementing some significant level of self monitoring. Thanks Sean

Karen Boyd, ASQ CQA I've seen illegitimate knock-offs or otherwise used (previously sold) medical devices up for sale on eBay. It is illegal, with respect to the devices being re-sold or re-distributed in a public forum and should be void of warranty from the OEM. The OEM suffers, as their name could still be on the product or it could be generally recognized as their product. OEM's should be vigilant, place a disclaimer / warning on their website, about unauthorized sellers and report any of these off-market sightings to the FDA. Unfortunately, it's buyer-beware last I've known....?

Karen Boyd, ASQ CQA Also, the OEM could try to buy them back when these typically low-balled knock-offs or illegitimately marketed devices show up on eBay or other auction sites.

Julie Omohundro What type of education would you want to provide to consumers to address this issue? And what kinds of actions would you hope to see them take as a result?

Julie Omohundro Yes, me too. I'm just not sure what information that would be. I don't know of any way a consumer could confirm that an item being sold as CE Marked on eBay is actually CE Marked.

Joanne D, I think you just swerved into a key item for consumer "medical devices & apps" and that is defining what "informed" should include.

Medicine is so complicated for both devices and drugs that getting people to stop and spend enough time to become informed is something a lot, maybe a majority of people won't do. Then some people are not capable of doing it, too.

I know 75-80% of adults check the Internet for medical information each year, but I wonder how many actually learn & retain enough on their specific medical issues to be fully informed?

In the app I am now designing, I will include a lot of links to consumer pdfs from medical organizations and the CDC, but my ultimate recommendation is to consult with their doctor if they think something is going wrong with their health to confirm what is real and what is not.

Ginger Cantor I'm more frightened about resale of more advanced high risk devices like X-ray machines on eBay. FDA has had discussions with eBay and Amazon on this, I hear.

Joanne, the field is so broad that some things are relatively simple and don't interact with other treatments.

Then others like for a person taking 2-5 prescription medications, especially when combined with Aspirin, NSAID painkillers & some "herbs", are anything but simple. Those combinations can have serious risks. It is those decisions that really do need a doctor, in spite of some meds being over the counter. The FDA does not require a drug to be tested against other drugs which might be used at the same time, so it is up to a doctor and patient to understand how to recognize symptoms of something going awry with medications.

On links, the items I would expect to use are ones from professional medical societies aimed at the consumer (and there are very good ones out there) plus the CDC & Medicare brochures also aimed at consumers.

I agree that clinical articles are virtually impossible for a non-clinical person to decipher, and are often paywalled anyway.

Sean McGee Considering some of the issues being raised in just the short preceding conversation, it will be interesting to see how the regulation of the medical apps market progresses into the future.

I'm not a pharmaceutical statistician, but given the number of different medications, both prescription and OTC, it is obvious that any clinical trial could NOT be large enough to cover all possibilities of mixes of different medical conditions, drugs, male/female, old/young possibilites. The number of different situations to test quickly become infinite.

Pharma companies can give generalized warnings about obvious potential side effects, but there can always be unusual and occassional side effects that exist, and they often exist once the number of medications becomes 'high.'

An example was a radiologist cousin who's mother at 90+ was taken to the hospital with 'problems.' My cousin comes in to see what's happening and the doctors want to put her on an additional medication. He looks at about 10 medications and tells the hospital, first we are taking her off all medications and then we are going to watch very closely what happens.

At the end of it, my cousin's mother went back on a single medication.

Sean McGee Burrell, many patients end up on a multiplicity of medications, especially the elderly. There is definitely potential for induced complications which doctors cannot predict, nor can the provider of a pharmaceutical product predict. Often the best approach is as you detailed, for the patient to be taken off all medication and "start again".

Karen Boyd, ASQ CQA Complicating this problem is the fact that there's no single, universal healthcare portal or app that can allow prescribing doctors to identify / review all of a patient's medications (and potential contraindications). The onus is on the patient to relay medication info to each separate healthcare facility or doctor. Otherwise, if the patient has all prescriptions within one pharmacy, perhaps that could be a 2nd source of identifying contraindications; again on the onus of the patient.

Karen Boyd, ASQ CQA (I agree, the elderly often suffer most in being over-prescribed.)

I agree with the concept that a person or their insurer or a single database should keep a list of all medications each individual person has, so doctors can see what the range of medications and doses are for any patient they see.

My cousin's mother was an exception in that she was a life long hypochondriac. So every time she felt she had a new symptom she went to a doctor (often a new doctor) and had wound up with nearly a dozen medications. She was actually quite healthy overall and lived to her mid 90s.

Julie Omohundro Certainly doctors should have access to information about concomitant medications from some source, preferably the patient. That said, I think the value of this information is still limited because I think Bo is correct that there are too many potential combinations for even the majority of potential interactions to be identified.