Mobile Medical Apps & the US FDA Regulatory Oversight Still a Thin Red Line 20140914

we'll get started with today's webinar presentation my name is Don Van Dam and I'm the president and CEO of 1 million solutions in health and we're very happy to bring you this presentation today about mobile mobile medical apps and the US FDA regulatory oversight a thin red line so this is our presentation and let me just give you a little bit of background about ourselves 1 million solutions in health and then I'll give an overview of today's presentation and today's speaker so at 1 million solutions in health our goal is to improve healthcare one solution at a time and we're doing that in the area of life sciences in healthcare and for patients and consumers so we're very excited to be bringing this to the marketplace and expanding it even further how do we help people do that well we help you connect people who are working on initiatives around the globe to improve healthcare to accelerate life sciences research and to share patient and consumer focused ideas and solutions we'd like you to join our community to learn and share your knowledge and ideas through events live events also webinar events like this one discussion forms and articles and help evaluate new science and technology initiatives so if you do have some ideas please send them to us whether you be in academia government if you're an entrepreneur or your business and will work with you to see how we can share your ideas with our full global community around the world so let me give you a little bit of background about today's presentation and then we'll we'll jump into some more information so we know that mobile medical apps have become sort of the darling of the M healthcare or the mobile health care these days no less than physicians healthcare providers and payers and of course consumers themselves have started to adopt and use all of these mobile apps in various ways you've all seen the staff the statistics and we've just scratched the surface the global mobile healthcare market is estimated to grow exponentially over the next five to ten years and no less than silicon valley has joined the fray what with the recent announcement of Google's contact lens embedded glucose monitoring chip that measures glucose levels from one's peers so mobile health has entered into a new kind of error a kind of silicon valley needs dr. Kildare so to speak so I'm probably stealing a line from ramen in the presentation later so currently fitness and wellness monitoring smartass dominate in this early stage of em health global market growth and you can do all kinds of things that are helpful for monitoring and tracking but some of those fall short after that initial gee whiz euphoria you so let me just give you a background on rom and then i'll tell you a little bit more about where we're headed from here so Ron belani has a broad and extensive career he's an experienced pharmaceutical biotech and medical devices IT industry the best business development expert and entrepreneur he is the founder and CEO of FDA smart a pharmaceutical consulting and business development company with wide reach in emerging regions including asia-pacific India China and Africa so bringing some of those technologies into the US market is one of the things that he specializes in or his company specializes in ft x mark delivers US FDA regulatory submissions and GMP services new market intelligence and assessment consulting and training services to the pharmaceutical biotech and medical devices industry in the US and asia for medical devices SJ smart offers consulting services including regulatory submission of 510 k a premarket notification mobile medical apps evaluations for compliance with us fda IFRS from CDRH startup funding and business development or commercialization with its global network and partnerships so rom is a frequent speaker and presenter in the global pharmaceutical biotech and medical devices industry on a variety of topics including US FDA GMP in emerging regions like India and China and he's done a lunchtime series in the in Europe on mobile medical devices etc and he's a regular contributor to various pharmaceutical media print and online publications both in the US and Europe so one thing I just want to explain before we move further is although you're hearing this presentation today from 1 million through 1 million solutions in health we are also or I am also the president of another organization called health connections and I'm just going to flip to that slide if I can in a second okay there we go so health connections is a commercialization company so whereas 1 million solutions and health is a not-for-profit bringing you science and information from around the world health connections is an organization that helps you commercialize your science so health connections has partnered with FDA smart because health connections provide services in the following area strategic planning and consulting market research marketing communications and education and training so after this presentation if you're interested in following up with either health connections or FDA smart about what you've learned today we're going to give you our websites and our information but there's just a quick look at the health connections website I'm sure you've seen it before but we're going to turn back now to the main presentation for today and turn things over to rob so he can give you the presentation and the information all about mobile medical apps and where they're headed for the future so with no further ado as soon as I can click through I'm going to there there we go and I'll turn the presentation over to wrong and let him unmute himself so that he can give you this leading edge breakthrough information about how to look at mobile medical apps in the world over do you wrong thanks dawn good morning everyone and thanks for joining us on this webinar especially when I thank health connections as well in 1,000,000 solutions in health of court for organizing this webinar you can all see from the title of the webinar the US FDA has now weighed in in terms of regulating mobile medical apps or health care for short the park has a title that says it's in red line Wilson crystallized if not mid for the late part of the webinar our goal is webinar obviously to help you understand how the FDA will deal with regulations event healthcare mobile apps including those that are just software present themselves the success released existing medical devices the wearables mark implants or turning a mobile platform into a medical device which can be done with the basic dollars be obviously you think about it USB it's debbie is kind of between a rock and a hard place so to speak they are continued to be expected to monitor and preserve safety and avoid risks and you chronic introduction by their medical devices and yet they can't be so tight with regulations that they stifle innovation which is obviously where were that is mobile medical up steps come in many flavors they can range from standalone through as I said expectorate existing devices they can do real-time physiological data monitoring or just convert mobile platforms into something else so all these complicates the US FDA job by the end of this webinar how you won't all be US FDA em health care experts are regular experts but I hope you all have least on kind of an understanding of the US FDA of mine fifth and hopefully a clear take away as to how the US FDA will rule on your medical apps or devices whether you are a developer healthcare provider payer or just someone like a consumer will be interested in finding out what are all those M care and healthcare apps and how am I going to be protected in terms of what I buy some Google or Apple Store sort of thing so moving on the next slide we look at our agenda we will start with an English people overview projection statistics and surveys no webinars complete without them will do this from three different perspectives of the industry perspective what the numbers look like will present numbers from the health care providers perspective as well as those of the abduction challengers and of course will consumers then I've got a couple quick slides on old-school versus new-school Silicon Valley we go there and Don don't worry I've already copyrighted that phrase and then we'll switch over to medical devices and what I thought we do here is just to even the playing field as far as a webinar listeners if consent start with kind of an overview where us FB rule the medical devices today and then after the mobile medical apps diagnosis relief we could September 2015 so then ground zero for mobile medical apps ruling from the FDA a couple of quick slides and what Washington DC is doing how they're getting involved with trying to get involved with the ant healthcare space and then we will filter out a decision roadmap and wanted two different ways to some examples and end up with our LED diode and my kids own are examples it's just to make sure that it's the people believe in webinar and if we have some time which I think we will without some Q&A is love so this light talks a little bit about the drivers or em health care what's what's really happening here while the hub of all of a sudden were flooded with you know mobile acid and medical information systems monitoring systems also to think to help us get healthier and better faster well three things really the first one first the bullet point talks about the conversion to their mobile devices we can't leave a spot phone he places the medium big data and then the middle slide is what I want to focus on middle slide is a survey with health care provider company looking at what these guys are doing how the viewing this whole tectonic shift in health care and readable percent on the blind of all healthcare co survey exist if customers will transform their businesses versus sixty percent of other things please so that's what the big gaps a do pre-empting how consumers I change the way we do business another another number which is not in this life is that almost all ninety-four percent of healthcare company CEOs plan to alter the customer growth and retention strategy and healthcare and healthcare being a speaking part of that foot folio is something that they're really scheming on looking at and study the simple message through their world with a numbers like first one here is of course Lee a overall and health care and it's a very aggressive number diced 58 million projected like 2020 that the CAG are compounded annual growth 32.3 percent between nine thirteen and twenty twenty the report that I thought the statistics from but the deals is dead and by the way for these reports that I'm drawing number strong not as a theory on his life you'll see to shoot off daughter myself I see how you wish to get more of the links from which this does not this company the grain back to the stat specifically the report says that the critical health monitoring devices that market alone will group 16 billion by 2023 up for ten seventy million in 2015 so quite a huge jump in comparison consumer monitoring applications were smart after medical apps are expected to grow to only seven billion so a big number that's the big gap between clinical health monitoring and those are consumer modeling apps into certainly enough what we see today is just just the opposite it's the it's the driven mostly by consumer monitoring and health and healthcare act at this point the clinical health monitoring from providers and other stakeholders are sort of falling behind and the reasons are fairly obvious our degree clinical health care providers have more regulatory hurdles and position work for integrations you know back-end data systems and so on that'd be great with so they're creeps towards serving this markets going to take a little bit more time another interesting number for you 2013 mobile health news as there were two hundred five apps with hospital brand so you can see we've gone beyond this consumer fans here even the stakeholders the providers are finding the fake too developers deliver solutions this makes light shows a few numbers from the providers perspective on the dachshund from the clinical go on the focus from em health care act right now are collecting data are constantly check the police artifact monitoring clinical data lagging behind that up from 27 34 is still a lot of capturing things from the political possible health care providers study right that's the big difference the bottom the bottom bullet point is equally interested in that when the lag that I mentioned in replied earlier not only thirty percent as well so does a ticket comfortable at this point in going mobile health apps and one we're Duke ocean a function these numbers they're obsolete the Minotaur produced by whoever produced them shall elected to guide and not really Bible numbers become Susie could change for the time from the scene of time I I grabbed offices today's webinar second slide shows numbers this time promptly consumers perspective quite impressive 20 47 million downloaded mobile out there after twenty blog and consumer electronic Association projections goals for twenty-nine percent of mobile phone users with health problems will try their own this reflects out there on the bottom bullet point you can read off you're not just using mobile phones and although the ways including healthcare became all right looks like it's interesting I it produces just to create a a benchmark on on where we're headed with the future flights coming up so I see I see em health care or medical devices and sort of the old world in the world old world establish device manufacturers platform provider until we have the folks like BP well talon IDM Cisco's and throw and polycom with a color health product so data collection at the healthcare setting as i mentioned portable not necessarily reno time or wearable for that matter and short only the archiving historic and cloud-based solution in contrast to that new world changing very rapidly emphasis here is on consumers measuring and sensing their own physiological parameters or health tracking stats anywhere anytime so oftentimes wearable and some cases implantable focus on sharing a day day doesn't do me much good if i know my blood glucose levels my doctor goes in fact I'm not a physician after all and then of course with the sharing comes electronic health records being a cloud storage access anytime anywhere by whoever i enabled to the leader right stick slides interesting a TV image of the iphone that's not by accident and overwhelmingly it's it's an iphone world out there in terms of the number of apps seconded by iPads and Android comes first now of course these are likely like this came to see me forward also those of you that are diehard blackberry users are just myself or just gonna be out of luck because if you can tell the blackberries way up there and just flr call for and now that's on on our business birthday gas that can see the switchboards Android or iPhone iOS so a little bit of a drill down on the new world scenario the new world em health care as we Apple stands to frame we've got google as well as i was light on them coming up on this on this deck laughter apple and i Scout you what's going on with with apple and the things that stood up for recent happenings are basically their apple health care just get sorry clinical trials going on with stanford university hospital and not study they're trying to connect diabetes diabetic children with the deficient tracking their blood sugar levels on another study with Duke University their enabling physician subtract blood pressure weight and on the physiological data patients of the diagnosis heart disease or cancer so these two seem to pop up the middle bullet point you all know about of a chain the celeb Fiasco with the photos a lot of work that we can get done with the backend storage and thought storage closet because of security and you should I got here is at the iphone or the Apple people aren't leaving a two step process to help secure lat gap and a lot flies very less the bullet point I'm very very interesting shows that despite us fda being out there looking out for us they ain't gonna be monitoring every apps about you can download either apple store a middle school and so buyer beware there's one that stuff it's still very interesting with the FDA corner and I see floppy arielle vendor us imagine a blood pressure application with an iphone camera and that's little bit of time system and assess the message here just be on the lookout for what you download is there for mental health care app applied on Google we Google of course we should most development the in the early early stages of a prototype contact lancer and dotted mention that another blog googled level three tiers their latest pathology fairly they've embedded coolio zune software contacts life administered embedded wireless chip insensitive and then either be good level community about that's really a while there but even even more of a while is nanotechnology there are studies underway that are using carbon ality without technology to actually float into your bloodstream and do the same thing as your blood glucose levels with real time communicating capability to the outside world we truly state-of-the-art but in development we should strangest right now so last bullet point talks about Google calico i'm not sure if you folks are familiar with out that the new spin-off company that google started focusing healthcare their main objective here are to look at how they can liver jam health care for aging problems or problems or healthcare issues that the right of lack of ability of the age and mental health Oh big differences i as i wrap up the apple raqesh google look is that for the apple has actually already met FDA Commissioner Hamburg and B she's looking for more things they can do how can they become more of a you need to zealots in terms of and healthcare emotions they call themselves the fact as well they consider and health care as kind of a moral obligation seal on the falafel and served ability wish i were as google to bring her said look it's really a difficult market in your into it finally regulated I don't know what we can do pollution our foot Silicon Valley we use it innovation free rein that's not only TV Webster FDA's fooling with okay so we are going to start getting to the meat of the webinar sure but while you were interested in listening not all the prior stats and trends and I apologize if you already know all of those um when I consider ground zeroes we fit the number 2013 that is when the US fda released the mobile radical happy guidance and for those of you are not the familiar with other US FDA works and guidance kind of a suggested way or here how to get the eighth innings policy not necessarily Warlick legally binding so it's housing mph going to be approaching complex this guidance they released it on the 2013 was actually in the making for years they've had a first rap early since July sequester king and the reason for that is the FDA third for active in something soliciting what the public wants to see what the embassy wants to do in put those you know what may work what will not work for all the stakeholders out there but you can imagine a lot of excitement after the FDA's weighed in with the mobile medical apps regulatory oversight a lot of confusion some of the confusion comes from believe it or not the folks we elected in Congress and in Senate plan PDF of the slides on those later on so key points for FP a regular with regulatory mission here how do we now regulate mobile apps right give it some great range of innovation creeping without compromising the safety and you can or risk the old medical devices world of these fellows they're going back to the old medical devices free and healthcare world at the SF be a dozen long it's just kind of a primer the usat looks at medical devices a certain way you know can't go into too many details do at the time we have essentially nothing bulk of it is that the FPA looks at 1700 dinner if device types they're grouped into sixteen different panels each panel mathematical sexual things I the flight coming up that will illustrate back a little bit and they have the class categorization here class 1 class to class 3 class 1 in the least risky device class to Shawn brisket flat 3 we have to do a DNA so you know class one comes in with what's numbers general controls general controls life includes things like registration of the medical device manufacturer their establishments listing with a hefty edge at the Aiken fact we doing what and so on and so forth that and that's for class 1 general Coco's glass do fbhs well your uncle joes are good and you must have that your control goes for all classes but we need special controls as well the special controllers women queens are things that are device specific so you know the device performance standards the post-marketing surveillance data on on that particular medical device lasering requirements specifically for that device so on and the last one is a one class ring the most risky or elected to the this Kelly will require a premarket approval application similar to a drug clinical trial the 510k actually fits in class 2 and more warrant on 510 K coming up in the next month so once again just distract how the FDA looks at things today device to the FDA is an apparatus instruments implement machine in class anything that it intended for use in the diagnosis of disease or other conditions or the Cure medication Chris mental prevention and we be in that are animals the bottom bullet point fold so addresses what the device is the courses definition that is it's not a drug it's not consumed orally as realizing sniffling the metabolism or transformations chemical sue to be defective that in essence the definition of 58 we got to a medical device some samples that I alluded to there looking at the middle part cardiovascular so cardiovascular is a panel it is regulated under TFR whatever whatever God takes 70 I am I provide you a link out there so you can kind click back and as you've been gone I think this presentation will be uh it's being recorded and will be available and I'm not sure whether on request to us or download will be made available for the dog can address that later on so just a little bit of a walk through in terms of how the FDA regulates that is good about this today now as far as and health care of mobile medical devices as off this gate which is 2016 at the bottomless life there's been a hundred and three mobile apps registered as either platform let's see what we I don't have a breakdown so I can't share them with you but I can share from this live at the bottommost bar there a TV set for healthcare provider cool without Holly 30 blocks go started 40 apps we've got cardiovascular death in the middle and diabetes even a little bit more that caused the vessel so just kind of a nice way to look at what's in a food from the map out there by yes yes a few words about 510 K I'm not sure again the audience the wide spectrum here with that developers that established medical device people maybe it was in regulatory experts out there but for the most part ninety-eight percent of devices are introduced in the market go through what's known as a premarket notification by grant submission and where's only two percent have to go through the pre-market approval equivalent to drug studies clinical trials and so on so premarket notification 25 sep a really not a very difficult concept to understand but not so easy to implement and it is why the five different a premarket notification is is more or less peril to what angers to NBA to abbreviated ND age to NBA jean-eric through innovator draka so the intent here was to speed up the process of bringing new medical devices in the market in the united states and the way that this is done is if I am a new medical device manufacturers I would look for existing legally marketed products the devices as close to my products as possible the notice predicate and then base my submission on that now my mission to prepare this is what's known as substantial equivalence basically why do I think that my device is equivalent or not exactly identical that closely good list but explaining the differences of my submissions to what existing so it's kind of a arts and that attractive same time besides for coffee because fundamental factor I sure know everything to know about the device and design the data to this and ariella but how do i begin to choose the closest equivalent to my device and that's really key to preparing 510 case we was just prayin for that for the company at ps1 and oftentimes we have to explain to our clients why we take a little bit more time than others to look at the credit experts face because in the end that closed down a custom all the technology differences that either need to justify to the FPA so that I provide the essential coolest justification presence alright shall get back jump back to do a guidance September 2013 and that was released by CDRH center for device I do like to go health and division of us fda as I've said earlier was published 2011 leave a year after the linker actually point you to the actual guidance we're not going to go through that line by line but what I've done in this webinar is created so the way a two-part roadmap and the first part is why we're looking at that the federal response right standalone mobile apps right looked at the view by the FDA in terms of how they meet the definition of a medical device which is this guy like so the first question comes to mind is is it a medical device does it meet the definition laid out by 2018 but the FF VI if it does next question becomes does it pose great risk or compromise safety if yes and it's regulated by the FDA if not we're talking about mobile medical apps now devices if not then the usf team uses its discretion for regulatory oversight this is where the funding thin line comes in and what is that word mean discretion so discuss a little bit more later on so another way we looking that this whole thing is with examples so on the first bullet point of their medical after meat medical device definition device we version is laid by the FDA and clearly subject essk regulatory enforcement what's a good example of that well and good example of a medical well sorry a good example of a mobile app that can be construed to the medical device is one that uses a censure or LED leads that is connected to a mobile platform that measures and displays electrical signals produced by the heart an elective artograph a BCD change somehow peered into a mobile apps and that would def radicals like GPS NLCS or so forth with the under-21 50 of our 870 regulatory saw parts of their field the second bullet point talks about medical devices a medical apps I'm sure that our medical devices but may not require USS they register environment unfortunate because they pose no risk well what is an example of a example of rocks could be a apps that create reminders for taking co perhaps an app that provides motivational guidance to smokers to try to quit or an applicable well after using GPS location is amazing solar sucks mattox of alarma conditions are in that may cause ask my sister right last one clearly no need for concern it does not meet the definition of the medical device and where it free reign to do whatever it is that we do example the lap would be mobile apps that provides informational sex education with nature perfect portals that provide patients and disease specific information and this you to be aware educational or empowerment portals mobile app enabling trance claimed the ordination of women coat so on and so forth so kind of summarizing the usf be a fan of mobile app i initially mentioned coupon for farmers and loans with the stuff that second part or actually the bullet points at the bottom of it slices so apps that intend to be used as an accessory the regulated medical device or an app that transforms a mobile platform and go regulated medical device and these are equally under the purview of the US FDA and needs to be considered your respective life on a factor or potential buyer the technologies into the technology a couple of slides on what's going on outside of the FDA that involves Washington DC or rulers at be in New Zealand first one is known as the respect acts ah gotta love acronyms perfect is some beefy this was bad for preventing regulatory overreach to enhance care technology right basically what this is I believe these are Republicans weighing in trying to paint believe it or not the ssds maniacal overreaching regulatory agencies for the stifling innovation in the nature and health industry that Republicans in charge of the FVA sir expand on the enforcement I'm sorry discretion by regulating the dynamic mobile health and mobile applications market with September 2013 belief in the final guidance medical mobile apps that surprising we have a people such as the IBM verizon female health you know the establishment supporting this standard position what what it means to the FDA we discussed what it means for the mobile devices industry not are you sure the text act I believe if they ask that even what a fart saying that look we need to transfer some of these oversight of mobile medical devices into niche the National recipie Standards and Technology away from the FDA so very controversial either thing that's that's where that is there a second part to this is coming from the Democrats with a few Republicans you know few them do it and this is known as the software act and accents with sensible oversight the technology did that is very very efficiently another winner of an acronym from our folks and easy who should portrait those Democrats will appeal Republican an elective provided link here that will get into the leak of what's what is just about but very briefly in the time we have remaining they address this in terms of three parts the first part is what's known as the medical software affection in here if we must align themselves with the prior ruling of the FDA in France's what medical software is they focus on things that are intended for human family intended to be marketed to change the structure of any function of the body of manner animals second thoughts of the pieces is political software where they claim that it's anything that captures which analyzes changes the presentation the population clinical data information that may recommend courses of clinical action that does not directly change the structure of any function of the bodies pay for that second part of the regulatory anchor that they walked away in the third one they consider itself software they could be those that have significant support of operational aspect okay no the health risks or they of cursory or potential of touch point here sense of mobile medical devices show both sides of these you weighed in and at this point in time a lot of noise not nothing we worth mentioning in terms of progress or milestones tablet with the the protect tactical of big slow clap right so in the end when the women houses USFDA really regulate mobile app boils down to the definition of what the intended users of the mobile app back what is the intended use for the mobile app and there's a big label Africa will bring up a second that illustrated with examples this example likely comes from the link that points to the USFDA mobile medical guidance I alluded to earlier and it's a simple example that does bring on the points though first you staged we're looking at an LED light emitting diode in the first few space you know it's used merely as a way to light up the space or room obviously a standalone not a device notice this close no safety concerns nothing you take the same LED and you it into an abdominal scope for another group mounted system diagnostic and all of a sudden it is concerned in terms of what that mobile app they they detail as far as regulatory older type it could be used for diagnostic can be used quite certain that series regiment and so on and hope the whole scenario had changes at that point the same the same diode used in a different context and really what that means intended use means the context of where it is with the twist that's coming up my example a little bit alright just kind of amusing but I think it does bring up the point we've all gone to tip and yaki places you know where their chefs like this and divers of food cooks it wanna lesson if you look at the left hand photograph of the ginzu knives example I use your leave behind closed kitchen doors away from restaurant goers drop on mini be celery and so on intended use there it is no risk to anyone that case in the best when you go on the right hand side image and that same window knife now changes its its usability right now it's not useful it's not that we used to chop up the food in front of you although there is some of that happening and now they're curling and and flinging this gives real nice in front of six people saying right across the sitting at the table same instruments just like the only be earlier example but now intend to be nice if I intended you now poses a risk if i'ma the Japanese chef there whatever actually I am working at dipping active excellent and the bullet point on the top gear says us fp8 houses it's the intended use of the device and here's the missing point of the flight fire coupled to the level of risk to one's health and safety right could become failures in the Hughes the really drives the overwhelming mindset of the FDA terms of how they step then how they stepped up went with a regulatory enforcement of whatever devices your mobile apps in this case that we may have and a little bullet point on the bottom to something I let go their house makes me hungry to think by Thursday how I know what with that I finish my presentation and i believe on we have a few minutes for Q&A so I'm going to turn it over to go on as well yeah thanks wrong actually I think you're led example went by really really quickly so could you just go back a couple slides and show us that one again right so the LED example right is a similar to the Ginza one but in this case the first case scenario is if the standalone good mount so it's used somewhere just to bring in a little bit of light not embedded into any Diagnostics that may be used to you know treat or diagnose patients and so on now that same Led posed in terms of karma scope changes context right now it's become part of their not spitting device and the phonology looks at your eye during examination and contender diagnosis on your retina and so on and so forth the same Led different context usage that becomes different concern out but this is actually a good example and this is the example that the guidance actually means it's on that makes it okay if you guys r answer the question yeah that's great thanks so much you could go to your your last slide there so I'm just going to tell everyone i think i forgot to mention it in the beginning but we did put it into the chat box that we would love you to send in any questions via the chat box and then i will ask ron belonging your question and then he will answer it so i offered up to you to go in and put in any questions in the chat box and then we'll take it from there here is our contact information you saw the health connections website previously and here's the FDA smart website and wrongs direct connection information so wrong I'm going to ask you to or have the I saw the host flippy the ball back to me and then we'll go into the question so I'm going to ask you a question here that's come in wrong and we'll take it from there so the first question is most mobile apps today our fitness and health tracking applications yet as you indicated it's the clinical smart consumer driven chronic disease management that will make and a significant impact in the future you can can you explain more about that and why that issue that is the case right oh I think the the comics from from google kind of brings on the points of a star the fact that fergie brings that you know they that they find the medical devices and health apple highly regulated there's some truth to that gender is a necessity devices you don't want every convict and I ought to be introducing new things out there without any any oversight however the start of thick today is from into the news from folks of our startup not from the healthcare establishment in other words so these guys are the last are going to jump in most of the times we've seen in other industries when we market forces them to react a certain way will they actually come to the picture show and going to the example of healthcare providers they are starting to recognize that more and more folks are demanding access the information and you know away from the clinical setting and so you know it's a question of time where we will see the shift from a consumable only consumer driven and have their universe into more and more were the clinical hospital caregivers are involved with after all closing what's wrong with us that is no good if you don't have our expert doctors informations and a guy occasioning and that baby discount this way in so that's that's what I'm not bother okay great thanks wrong so yeah just please send in some more questions and again at the end we will also have a little questionnaire that we would like you to fill out to give us some feedback on this webinar and what you'd like to see in the future so on the next question for you rom is if an app is intended for pregnant women if an appt attend intended for pregnant women provides information such as ways to identify a maternal or baby disease would that be potentially regulated by the fda if not who controls the quality of the medical information they receive quickly reports and all little one sure if an app is intended for pregnant women and and that app provides information such as ways to identify a maternal or baby disease would that be potentially regulated by the FDA hmm I think that's one of those that lie lie only in the you know in the middle you recall one of the categories we had that yeah they can be looked at medical devices that cookie low risk and you know it depends only appeared to take a look at sia you know I guess the details of how the app works and what is entailed so let's kind of a middle ground little crowd middle ground cajun re over here not clear-cut ya go you know go out there and use it all all the heck that they're not exactly one that I think he shoots a super highly regulated at the clinical setting either so that's got the top one I guess the answer I can give is I don't know maybe yes maybe no I guess part of the question revolves around is just an app being used by physicians is it being used by nurses is it being used by patients I would say if it was being used by patients that would be pretty you know pretty severe because of the second part of this question was if if not regulate by the FDA who would control the quality of the medical information station that's being received buyer beware we mentioned that somewhere only are one of the slide step it down it's a bonanza out there and the FDA is doing its best to work with the issues that can't do it alone and you know it's just a difficult difficult environment but one they realize they can't start in the way off because the progress happens and they've got to let go some of that closures that they've had in the past ok so I'm here's another question for you so in your webinar you talked about the fact that intended use and level of risk are the two key factors to consider when dealing with US FDA regulatory oversight and mobile medical apps is this correct and can you just highlight a few of the points there right right pocono from intended use of course is what say what the system was designed to do start with and we're coming up on here where you know medical devices was very clearly medical devices and there was no he weighs about it like once once he got the clearance p a PM a week for the root of the 510 K you know it was he was fairly fairly clear ready to go not quite the same with himself would be application site it's quite challenging in the sense that the intended use sometimes can be can be modeled depending on not only the user that the case scenario is it's used and in fact that's why I think the FDA's left itself an out and that's in that fight I showed where the old days with either a medical device or not in this case now they're saying oh it could be a medical device that get what to use a discretion in respect way though these are these are good questions very difficult and unfortunately not something like this okay so another question that's come in is if an app is made outside of the US can the FDA regulated and maybe I'll just add a little bit to that question and say I think there's a difference you know there's a question of the app was made outside the US and maybe the company is outside the US I guess yeah which one is it that would help clarify our answer well the question specifically is made outside of the US can the FDA regulated but I guess it all depends upon whether it's know the person is just at both it's it's made outside of the US and the company exists outside of the US but I suppose this person wants to market it in the US or maybe you know right welder the key piece is pocket in the US it doesn't much matter which produced its needs to go to it it needs to go to a 510 K of peace process in other words or ok so so to just no matter where it's made doesn't matter where the headquarters is it is if it is going to be offered in the US then it needs to be you know considered from that perspective absolutely right yeah everything falls through the US FDA when it lands here it doesn't matter what come from it it's cfpa that we need to tackle this okay so here's more a future-oriented question for you health care providers have been slow to adopt electronic health records you think that the rising adoption of mobile health care with consumers will speed up or force the adoption rates with the health care practitioners and healthcare provider networks and things like that that's a really good question and I think the answer is yes definitely obviously the whole anchor of the one felt is the electronic health record and we're entering a world where it's moving away from discrete procedures into outcomes-based right big thing with Obamacare we need to be more outcome-based now rather than procedure based and that's going to be very very difficult to do if we don't have a repository for everything that happens adopt me on around the right to share regardless of who the stakeholders at once to look at it though I think we will see electronic health records getting adapted faster and faster with the advent of the team mobile medical apps of which being a good time okay the other thing that occurs to me is just even if you look at the meaningful use payment schema that in there there's probably some ways that you know physicians are required to record some of what their activity is or the patient's activity and the medical appt certainly help in the collection of that data so that might be a way to incentivize the physician and the healthcare community to get more involved in action and use them more exactly oh yeah absolutely i think electronic health records will be shift its popularity is going to speed up here quick okay another question here will the u.s. do you feel continue to lead the global mobile healthcare and mobile apps innovation or do you see other rising places that are going to participate in this process good question i think yes i can have a day of a shofar answer for that once that look at health innovation technology innovations a lot of it starts from the US however about with an industry for business you look at the markets out there and we've got people in India 65 million diabetics out there and in China about the same number so any type of solution aggressive be easy is likely going to be a big big interest to people out there but there's going to be some competition and in terms of like think one space app for knowledge established that i still feel in the end the u.s. is a head of the pack in terms of innovation and you know we are looking at things they're like what I cited earlier a nano technology that one can confuse a little blood stain measuring Lukos levels with it now these are like a fantastic boys movie made real thanks those kinds of innovation I still believe will will start on the u.s. not exclusively but overwhelmingly I think we'll still company you up okay great thank you so just a reminder to everyone that the survey has now put been put up in the chat box and we'd love to get your feedback on this webinar and also your ideas for future webinar presentations and also just to remind everybody that there is still a minute or two if you have any questions that you want to ask again please put those into the chat box which typically is in the middle of your screen on the right hand side so um here's another question for you rom how does Apple's vision for em health care vary from that of Google vision for mobile health care ok I excluded that earlier dawn basically Google is a little bit more cautionary in terms of how do you wanna play into the healthcare space DM healthcare space they are the opinion it's two very highly regulated compared to what Apple things were Apple is more or less very much eager to support the status quo they've been to the US FDA visiting with Margaret Hamburg very proactive there so and that's one slide showed Apple does lead the way in terms of and healthcare apps that we've seen those you know dynamics are going to change that that's I think the main difference between these two companies we may finally be you know do a reversal for keynote that Silicon Valley after all or nothing Space Shuttle stay stagnant for sure for sure okay bull rom do you have any closing comments that you'd like to make but we wanted to say thank you very much for this excellent informative presentation and hopefully it's going to give people a lot of thoughts and ideas about how they can move forward or how carefully they should move forward so anything goes co4 thanks for the opportunity of making this presentation I'll attack the audience we joining in as well we'd love to hear from you guys in terms of feedback not just on this webinar but on thoughts ideas generally on health care after all it is 1 million solutions and help that we have in front of us there we'd love to hear from you email us or connect with us on Twitter or LinkedIn happy to happy to do so once again thank you all and have a good day great thanks very much again wrong and we appreciate everyone's attendance today and look forward to joining us our next webinar take care have a great day

Leave a Reply

Your email address will not be published. Required fields are marked *