and today we have doctors Bryant Lin and Oliver Alami with us Bryant Lin is a primary care physician educator and researcher the Cornerstone of Dr Lynn's work is keeping medicine focused on humans patients providers families and trainees and not lost in technology and algorithms his research and educational interests span one developing and testing novel medical Technologies two improving the health of Asian populations with precision and population health and three increasing expression and interconnections in the Health Community with the humanities and arts Dr Lin serves as Stan at Stanford as clinical faculty in primary care and population Health in the Department of Medicine where he has invented and researched new medical Technologies addressing unmet human-centered needs and started the consultative medicine clinic evaluating patients with medical Mysteries Dr Alami is a clinical professor of vascular and endovascular surgery at Stanford University and the Palo Alto VA and serves as the Director of Stanford's biodesign for digital health he is the course director for biodesign for digital health building for digital health and co-founder of the open source project Cardinal kit developed to support sensor-based mobile research projects his primary research focuses on clinically validating the sensors and smartphones and smart watches in patients with cardiovascular disease and translation of digital Health Solutions Dr Lynn and Dr Alami thank you for being with us and I will hand the controls over to you for your presentation thank you very much uh Jacqueline uh it's great to be here welcome everyone we have quite a few slides to go through so I'm just going to run through here are disclosures so our learning objectives today to understand a framework to evaluate new technologies articulate value propositions the limitations of digital health and also appreciate the economic impacts of these new techno Technologies I'm going to just start from the very top and talk about kind of why now why is it an interesting time and we're basically on an unsustainable uh trajectory currently with regards to costs of Health Care um the U.S spends about 17 of its GDP on health care and this continues to go up about three to five percent a year and you layer on top of that despite this crazy spend that our outcomes aren't that great uh compared to other nations that spend a fraction of what we spend at on top of that that we have a silver tsunami or an aging Society and then you add on top of that that we just aren't producing enough clinicians or providers to help um address or meet the needs of all these people that will have chronic conditions so any is the government realizes this and for that reason any new innovation that comes out that you know that will be supported needs to meet the triple aim or quadruple aim it really needs to have better outcomes than what currently exists at a lower cost and to be scalable and this just happens to be the sweet spot for digital Health which we believe or we Define as the convergence of data connectivity and compute power to increase access and provide personalized Health Care to improve outcomes at a lower cost and this is just a high level framework you know it all starts with the patient and the data generated around that patient whether it's through mobile app an in-person visit in a clinic devices wearable sensors that data data is then analyzed in a way and insights are gathered from that from that data which then feeds back to the whole system and Healthcare is very very very complicated it's very different than the Consumer world when you think about innovating in this space you have all these stakeholders to think about uh whether it's the insurance companies the government um CMS what's unique about digital Health when we do our needs finding for example around this space when you think in the through the scope of digital Health you have to include the patient at home as another stakeholder and that's what makes this field so exciting and there are certain enabling changes around data Regulatory and reimbursement as well as covet most recently that have really pushed things afford and I'm just going to touch at a very high level on what these have been it all started in 2009 with a high-tech act the U.S government again was very aware of this unsustainable trajectory and we all have heard of the adage that if you can't measure it you can't improve it and um so it was very clear that a lot we had a lot of paper charts we didn't have digital charts and the US government had a very hard time even knowing like where where is the spend what are the outcomes like in these various settings it was hard to measure so there was this huge incentive to digitize the electronic health record and there's various meaningful use stages where it was kind of a carrot and stick model where they were providing funds to Hospitals and Clinics to implement electronic health records however they had to meet certain criteria and it started with just basic implementation electronic order entry drug drug interactions for Meaningful use stage one and then it went to uh five percent uh patients need to be able to view download and transmit data which ended up just becoming the patient portal for Meaningful use stage two and these are just small segments of of these requirements but what you're seeing here is are the the government kind of mandates which pushed not only the digitization but also now bringing the patient into the the picture and and realizing that um they needed to make sure that this benefited and that the patient had the ability to view this data it was kind of the sap Oracle moment you know that way back in um 2009 when you know this really happened in the 1970s and all in the other Industries and by 2016 about 96 of the U.S Healthcare System had certified electronic health records however there's still the government still realized that even though the data was digitized it was living siled in these these various institutions or Health Systems and so the next evolution of meaningful use had to be around not only allowing patients to view their data through a portal but how can we get the data to flow outside of the electronic health records so they said that the data needed to be available or accessible electronically via an API and at that point they hadn't quite specified which API but that was the beginning of the hs7 fire standard being implemented slowly and coming on onto the Horizon and we'll talk about that more in March of 2020 the 21st century cures act final rule was passed and this is a huge rule um and this can is also it has an information blocking component as well uh which is really important uh and it and it mandated as this fire the fire standard based API to be the API so now Define the business rules of how data needs to be exchangeable and how the data should flow and then on top of that they uh they also man mandate that all elements eventually need to be exposed via an API or electronically and interestingly this just this just um because of Coba things were delayed quite a bit in terms of men when it was mandated but on October 6th of last month or October 6 which is last month of this year is when this finally came into um you know came into law and it's it's not being enforced quite yet it's not clear how it's being enforced you can imagine there's a lot of pushback but uh this is very much uh a reason why the data is now available and being um and being made available if we talk about reimbursement there have been also a lot of changes um which make or try to create an ecosystem right for digital Health most of the US is still fee for service based meaning that you get incentivized for heads and beds doing procedures keeping the care within the four walls of the hospital and again the government realized that this is not really in line with long-term with lowering costs and preventive health and and their the government's one of the biggest uh Spenders you know they they pay over approximately 50 percent of all the health care bills in the United States and because of this they've implemented a lot of quality uh payment programs and metrics there have been various various iterations whether it's through an ACO more recently what's gained a lot of um traction and growth is the Medicare Advantage program which is basically Medicare managed by Insurance other outside insurance companies such as Optum chenmed Oak Street Health Humana Kaiser at another they all participate in Medicare Advantage plans and what's unique about this is that these insurance companies or Healthcare delivery organizations actually going at risk for these patients meaning they get a bucket of money at the end of the at the beginning of the year and all right are then challenged to take care of these patients um and they're very incentivized to reach out to patients Implement all the digital Health tools they can for preventative measures telemedicine whatever it may be so some example some other examples of where digital Health has grown or integrated delivery networks such as Kaiser Ochsner health system is another nice integrated delivery Network system in the in the south in New Orleans and I believe personally that they're one of the most Advanced Health Care Systems with a really Advanced Digital Health offering currently they have antihypertension programs CHF Management Programs diabetes management pregnancy programs they have something called an O Bar which is kind of like a Genius Bar where um I'll walk you through a patient's story for example if I was diagnosed with hypertension in Epic they'd put in the order for me to become to join this program I would walk out of the clinic to one of these o bars pick up a subsidized blood pressure cuff they would connect it with my phone right there at the at the O Bar and then I would get text messages telling me to check my blood pressure several times a week that would go to Epic and a pharmacist would then review the meds and based on a protocol would send text messages back to tell me to either go up or down on my blood pressure medication and they have solid data on this showing that they can get much better tighter blood pressure control in a much shorter time so it's a great success story of how digital health and the right setting with the right incentives can really benefit patients self-insured employer employers are also very very interested in digital health programs at Starbucks for example pays more for health insurance for their employees than they do for coffee beans to roast other coffee so they also have the freedom to implement any sort of programs to better manage and uh chronic conditions and or any condition really that their members have and turns out musculoskeletal conditions such as lower back pain joint pain is a huge is a huge spend for all these organizations and they've for example implemented hinge Health which is a remote physical therapy program to help again navigate patients away from surgery and more towards Physical Therapy which is shown to be as effective if not better or more effective and then I wanted to touch on the regulatory as well FDA has been very forward thinking in terms of addressing all the AI software or other software and will it be regulated will it not be regulated they've put out quite a few guidelines that are available online they also have a website the the digital Health Center of Excellence website which you can go to there's a link posted here and they're actually very good at responding to questions so if you have any question about whether your solution is going to be regulated or not regulated you can go ahead and send them an email it takes them a while to respond but they provide a very comprehensive response and I highly recommend folks to do that if they have any questions they also made it very clear that we you know they will not generally regulate wellness products and I'll go into an example of that and the future such as omada omada health is basically took a program that was delivered in the YMCA in person which was a diabetes prevention program digitized it uh added you know connected scale coaching group sessions that are remote as well as health education and their program is uh not currently being regulated by the FDA so it's considered a general wellness program as an example and then you have other kind of software you know the Apple watch itself isn't isn't a regulated device however the software The Irregular Rhythm notification for afib is while other metrics that have come out such as the passive walking speed passive six minute walk test VO2 max or temperature gauge they've chosen not to go through FDA clearance so just to give you a high level view of the complexity of this and and really in some I would say for this first section that you know what has what is really a I think a huge Insight is that there's been a lot of clarity from HHS the Department of Health and Human Services onc the office of the national coordinator that really they want the patient in their View um they want to drive things towards a consumer or patient authorized data exchange so give the patient the key to unlock Health Data and if you are an innovator in this Healthcare space and you you would like you know to have access to your uh someone you're trying to serve or help with your product that they the patient or your customer has the right to to ask for that data and now we have a defined way to get that data through the fire apis and so on at least that's the vision um so I can I wanted to just plug Cardinal kit but we can get into that a little later and I'm going to hand it over to my partner in crime Dr Landry great thanks so much Dr Alami uh for a fantastic uh Whirlwind uh overview of uh the structural changes uh that have been happening that have encouraged and some could argue discouraged digital health I just wanted to zoom out a little bit it's hard to have a discussion about the future excuse me of digital Health without talking about technology and Medicine generally you know sometimes as technologists we always view technology is always a good thing and in medicine it's a complicated question because uh you know we have a principle among Physicians that are Hippocratic Oath of Do no harm and it's not always clear that technology is beneficial you can see a company like intuitive surgical a well-known company this is from a an article an editorial in nature one of the nature magazines uh and just a quote talks about how intuitive is loved by surgeons and patients alike for its ease of use and faster recovery times it's less invasively conventional procedures but the robot's two million dollar price tag and negligible effect on cancer comes is sparking concern that it's crowding out more affordable treatment so you know not clearly uh Do no harm and maybe there's some benefits but they're also some concerns as well about cost and potentially potentially preventing other Innovation from occurring and then you know as a doctor it's hard not to talk about epic uh Dr Alami talked about emrs a few minutes ago uh and uh you know there's a lot of resistance to adopting emrs initially and epic of course is the the biggest most influential uh EMR out there but you can see you know sometimes there are benefits even though it was painful can be painful to implement this was a study looking at the implementation of an EHR in the critical care setting and it didn't affect length of stay but did decrease the risk of mortality decreased mortality rates in the ICU and that was thought to be due to potentially medication error decreases as well so not always good not always bad we need to have a framework to evaluate technology and Medicine in particular digital health there are lots of perspectives in our digital Health course Dr Alami and I really look at a product development perspective and that's the entrepreneur corporate perspective but there are a lot of different perspectives out here just like you know if you ever visit the Leaning Tower of Pisa where are you in this big crowd can give you a really different view of what the Leaning of Tower Pisa is and what it looks like and how it impacts you and there's so many stakeholders in this environment Dr Lami talked about the seven-headed monster eight-headed monster and lots of different goals you know around improving Health but money saving money making money curing disease preventing disease many many goals around Health in general and digital Health in particular for example in entrepreneur can use this framework you know what do I worked on do I look at a large automatic clinical need do I look at something that's scalable has a pathway has a regulatory pathway a business model easy way to distribute and sell the product uh do you have any competitive Advantage you know are there other uh things you need to prove that it works like clinical trials how to use analytics to show that your your solution is something that helps outcomes or helps some sort of goal that you're going after such as saving money or making money now of course there's a broad societal framework looking at population Health can we you know from the government and um from societal point of view we want to improve the health of populations where you know we'd love to of course improve the health of individuals but looking at it apart from a population Health that can help you Marshal resources you know how do you put your money behind certain Solutions uh so they can help the largest number of people looking at prevention and management of disease value-based care this is where the dollars come into place and then this this is this new part uh which really digital Health enables how do you analyze this how do you use traditional research but also new methods of analysis to show that new Solutions are actually doing what they intend to do and not causing any harm again um so I wanted to also just briefly touch on what population health is um so the CDC defines population health is uh bringing significant health concerns into focus and addressing how those resources can be allocated to overcome the problems that drive poor health conditions in the population so that's again one perspective from the CDC so you can see how depending on your perspective you may use a different framework to evaluate technology so today I'd like to go back to as Dr Alami talked about the triple aim uh from the ihi and the triple aim again just to remind you is focus around improving patient care the patient experience of care which is around both quality and satisfaction improving the health of populations and reducing the per capita cost of Health Care so today we'll provide a few cases and talk about how we use that framework to evaluate new technologies new digital Technologies so we're going to talk about mental health oncology a couple of cases on collagen as well as I didn't include here a wearables Dr Alami will talk about case studies and wearables as well so digital mental health is really an incredibly exciting area lots of unicorns billion dollar startups in this area uh focused mainly around virtual care connecting people to Providers and tools not quite sure if they improve outcomes it's not clear here are some potential benefits um you know this is from a practical prospective a functional perspective notifications you can monitor perhaps track your own mental health you can share what's going on connecting to a professional being part of community and then having a dashboard just have a really big overview either from the provider clinician side or even from the patient side about how your care is going you can see here they're just focusing in the therapy aspect of mental health you know traditional approaches uh are in a uh looking at uh acceptance and commitment therapy act CBT PDT cvt's cognitive behavioral therapy and PDT psychodynamic therapy and then of course in B there's traditional treatment traditional face-to-face treatment and digital Health which sort of the digitization of uh A and B as well so kind of how do you convert these approaches uh and enable them digitally so just our case today we'll talk about cerebral so the cerebral's been in the news um you can see from their website it's just a screen capture from their website their tagline is expert help for your emotional health connecting you with professionals basically at a subscription fee um this is again from their website talking about what their results are what their outcomes are eighty percent of members have a niche visit so great Improvement in Access and it makes sense uh decrease in depression symptoms they don't really talk about how they track this or what the metric is and then uh you know significant impact a large number of people saying their anxiety is better so great these are you know sounds like all great things so what's their business model well it's um you know really a monthly subscription fee you may be able to get insurance to pay for part of this uh but there's a 30 monthly access fee that is not covered by insurance and then you may be able to get insurance to cover for extra things as well as medication but there's a problem with this model you know incentives are misaligned Wall Street Journal had a series of articles about how uh they really had a great increase in number of patients that they're managing but it seemed like a significant percentage of these were coming to cerebral for access to ADHD medications uh and there were problems with how cerebral evaluated these patients and their misincensives disincentives well misaligned incentives uh for people for their providers to actually provide easy access because they don't want to lose customers um if they are deemed not to be needing these types of medications which are controlled medications and uh you know resulted in more bad news you can see that they cut out recently Wall Street Journal reported they cut 20 of their staff um due to this bad publicity so you know these are challenging right this this is a company that did improve access seemingly improved symptoms uh but there was a negative side due to uh the incentives and conflicts of interest inherent in the way the company was structured so again let's go back to our framework uh improving the patient experience of care well one could argue that the satisfaction was improved right so some people did benefit you could argue about quality Wall Street Journal focused on the case study where there was one person under treatment who had a very bad outcome so this is unclear this first bullet on our framework uh did it improve the health of populations main maybe again depends on the net net benefit we don't know we don't really have enough data this is all secret to us right at least we only know what they've reported I don't know if that many uh peer-reported peer-reviewed reports from cerebral and then reducing costs again unclear whether they really reduce costs there's this additional monthly fee that's required so from a Health Equity standpoint it's not really improving access unless you're able to pay for it let's move on to oncology seven more Adventures a well-known Venture from in the area of digital Health has a great and I encourage you to take a look at their website a great kind of overview of how digital health is involved in oncology and this is a quite a broader review and you can see it's there are many areas touched including care navigation put around clinical trials detection and diagnosis we research and data management and clinical decision support so really a lot of companies in the space very popular area you can see how different Technologies and again the goal today is not really to delve into these details but you can see how different Technologies can really impact potentially possibly many stakeholders and benefit oncology care let's focus on this case here so this is I think the simplest case of where clearly digital Health impacted um the health of patients undergoing oncology care something called patient reported or e-patient report electronic patient reported outcomes systems so there are many objectives for these systems but we're really going to look at you know how this affected uh patients care and as part of a clinical trial but improve the outcomes for patients who basically self-reported their symptoms through electronic digital means so this is a system developed out of Memorial slim Kettering uh and you can see again the details aren't that important but patients were able to report their symptoms that they're uh having as they underwent treatment for uh cancer and uh they of course would they're someone who was looking at this information uh the clinical team and was able to potentially the ideas they were able to intervene early uh and so uh improved treatment and accessibility for the patients and this is looking at Survivor survival so we always think about oncology in terms of you know months of survival for drugs and treatments uh you know really advanced technology and this is really uh kind of a workflow intervention right you're enabling patients to report their symptoms to their care team you can see it here it's really amazing uh you can see the dark line as these are survival curves uh so usual correct care there was a higher mortality with usual care than in the patient report symptom monitoring group uh by uh and the difference was quite Stark so this was a seminal article in the space and led to the American Society of clinical oncologists to put this in their guidance documents that this is recommended for anyone receiving clinical Cancer Care uh so let's go back to our framework talk about improving patient experience and Care clearly you know patients are able to talk about their symptoms their their undergoing uh seem to improve quality mortality improve the health of populations decrease mortality and we don't know about the costs yet so that's something interesting but these Frameworks are fairly low cost didn't seem to require additional clinical Staffing um so it seems like it checks all the boxes for us let's talk about another case in oncology this is Grail Gallery um so this is what's called a multi-cancer early detection test so it's basically they're looking for tumor DNA and you basically pay it's a blood test it's around a thousand dollars or so uh and they will do tests looking for the presence or absence of tumor DNA in your blood and uh you know you can see here again this is from their website around 70 of deaths are caused by cancers that aren't screened for so this is part of the push for how do we screen for more cancers we have very few cancers such as colon cancer breast cancer uh cervical cancer uh and um some could argue prostate cancer that we actually can screen for uh but most of cancers we can't screen for so this is how they look they look at sulfur DNA from cancer cells you know different than normal cells this is what they're detecting um this is a performance from their large study which was published High specificity so 99 1.1 specificity uh but really not great positive predictive value so 38 so if you have a positive test what's the likelihood that you do have cancer so less than 50 percent um and then the negative predictive value is very good but you know of course most people are not going to have cancer and you need to screen 189 people in order to detect one cancer and this is from a different study kind of a value-based study you looked at and you can see that the mced plus usual care so Gallery plus usual care pushed diagnosis to earlier stages which presumably will enable uh better treatment and lower mortality we don't know that yet and you can look here the costs of course it did increase costs uh increased costs of screening um and you can see at every level uh did increase costs across almost across the board except for stage three and stage four because they're pushing more people into early stage detection and you can see here this is this is again I won't go into the weeds with the quality of quality adjusted life years uh but uh setting the price around a hundred thousand dollars uh per quality adjusted life years something a lot of these studies do and you can see there's a tremendous variability so we don't really honestly have the data to assess this yet so because of that um you know it's interesting because it's a it's not reimbursed by Insurance there's a lot of false positive risk um you know if you offer this to every Medicare beneficiary you know according to Dr Welch you could bankrupt Medicare so this is of concern so we really need to study these Technologies uh quite well before they're approved by insurance um of course because of this we don't know on a randomized basis uh so the National Health Service in UK is studying whether randomizing people to um Gallery testing versus usual care you know what the outcomes are in the long run and then of course they'll track costs as well so that'll be very interesting this randomized controlled study so looking at the framework for gallery you know it's possibly we're increasing quality and satisfaction hard to say you know false positive risks of course are not something we want as patients or providers uh potentially improving the health of populations again what's the Cascade of false pause of the diagnosis hard to quantify and the costs may increase uh overall so unclear on this framework whether this type of test is something that as a society and fulfilling the triple aim something we should support so stay tuned um going to hand it back to uh Dr Alami to talk about the next guest perfect thank you so I was gonna get into a little bit about wearables now Rune Labs is a really fascinating company their Precision neurology company and they basically not only ingest data from Imaging but what's unique about this FDA 510 kfda clearance that they got received recently this year their strive PD software or ecosystem you know leverages the Apple watch in order to kind of track symptoms so something that's really hard for neurologists is to get that feedback from patients you know did the medication adjustment improve your symptoms or worsen your symptoms and through this kind of strive PD ecosystem you they can more objectively track how the medication is affecting the patient system so here's an example where a wearable a consumer wearable really um combined with some other components and clinical factors was wrapped into this FDA approved product by a roon lab so that's a really interesting case study the neurology space this is more forward looking but I thought it was pretty fascinating again a consumer device so it's a a watch that can detect atrial fibrillation there's a big study that was just awarded a massive Grant it's going to be multi-institutional study led by Northwestern in Chicago where for patients with atrial fibrillation who would normally stay on a blood thinner and anticoagulant to help prevent strokes and so on they actually would monitor the atrial fibrillation uh because there is a subset of these patients that go in and out of atrial fibrillation so while they're when they have afib the uh study would then the study app would tell them to take their pill uh their blood thinner and if they don't have afib um they wouldn't so here's another just interesting kind of forward-looking um study to see how wearables could be used and mixed into the clinical practice or or just care and again remember digital health is you know care outside the four walls of the hospital where most most people live most of their time they don't we don't spend much time in the clinics or the hospital so that's what makes this really exciting and then this is a really I'm surprised alio doesn't get more attention so this is a another wearable it's a patch with sensors multiple sensors that you put over um what's called an arterial venous fistula and EB fistula or AV graft and this is something that dialysis patients have and need for long-term dialysis access and what's really challenging with dialysis patients is that they're fluid and electrolyte shifts are quite dramatic and they actually have to report when they go to their dialysis centers they need to report you know what were their potassium levels what it was their hemoglobin hematocrit and this patch through artificial intelligence and all the sensors is able to provide and they received FDA approval for this is able to provide a potassium prediction hemoglobin hematocrit prediction you know blood count predictions can monitor all the vital signs oxygen saturation and what's another really interesting thing about alio is that they not only provide the patch but they've spent a lot of time thinking about the clinician portal how is how are we going to deliver this information number number one and number two on the patient's side it's really Plug and Play so the patient gets this Hub that you see here on the on the screen right and that plug that Hub just automatically automatically syncs with the device when they're home or close to the hub so there's very little um you know work or or it's very passive it doesn't require much uh on the patient side which is huge because uh you know we can all dream up these great ideas for monitoring but if it involves a lot of work from the on the patient side it's actually um it you it's really hard to get significant engagement so the more passive something can be the um more likely you are to be getting quality data not to have what we call missing data so that is um kind of the summary there I'm going to give it back to Dr Lynn to close it out here great thanks Dr Alami so yeah just to sum it up it's already here we're already in the digital future we'll continue to evolve evolve evolve we really need to watch out for misaligned incentives so uh the reason why there's so much attention in this space is because there's thought to be a lot of money at stake lots of you know very valuable companies uh so from a healthcare perspective we need to watch for that and make sure that and that benefit is there uh looking at the benefits versus the risks so there's some unexpected risks unpredicted risks uh but there may be some unexpected benefits like you know I would not have expected epic to change mortality uh among ICU patients uh and then lastly we need to study these digital Health tools interventions um with traditional Technologies traditional methods clinical trials but also we need to constantly constantly have feedback constantly have analytics to show that really we are not causing harm uh and showing that hey how can we do better the beauty of digital care is that there are a lot of incremental things we can change it's not like a surgical device where um you know the days are gone where you can tweak a surgical device and you know immediately have that out in the market there's a lot of things that you need to do from a regulatory standpoint digital health is not the case there are a lot of things you can do and change about digital Tools digital applications digital interventions for health that don't require regulatory change they can be adjusted on the fly in conjunction with workflow issues thank you for your attention today and I hope you will also check out our class and I think Jackie will talk about that as well okay let me begin with the first question here um could you elaborate on why the government through HIPAA is holding on to EDI standard to transmit patients claim data to Clearinghouse organizations instead of payer receiving claims data directly via much better insecure encrypted systems what was that Sarah could you repeat the question which standard the ADI uh can you repeat about holding on to EDI standard so I you know I I'll be frank you know I'm not you know I don't know too much about that in particular because it has to do with the payers and I'm assuming we're talking about claims data going from um the hospital to the payers so I I don't know much about that but I I do know that they are trying to move everything to more like fire-based um protocols and standards that's that that's something I do know uh that's I don't know if you know much more about that Brian I don't know if it's the government really holding on to it there I mean there are definitely standards that are mandated um but like anything there's a lot of slowness and you know how do you enforce these things so I think it's sort of there you've got to have a stick right you have standards but you also anytime you have standards you need to some sort of have some sort of incentive how do you make sure that everybody is kind of uh following the mandates and the rules that are set up um so yeah my perspective is just that's not necessarily built in there really yet um you know just sort of like uh you know um you know how when bmrs came out right uh you know when when you're talking about you know are you actually using emrs the way it's supposed to be used so you know they had incentives and and and carrots and sticks there as well so yeah but definitely not not an expert in that area yeah okay thank you and the next question is how are the advances in Sharing Medical Data impacted by HIPAA it seems like there are many areas where data sharing may cross over the line that HIPAA seeks to protect yeah so I I love this I love to I'm sorry Brian I'm going to jump in here just because I'm really bullish about this I I think HIPAA is there to protect us you know hip is not a bad thing it's a it's actually a good thing and I'm truly believe it's there to to help us and again the government is really pushing back against hospitals that's that you know is trying to hold on that are trying to hold on to their data and not share their data again it goes back to that one slide I gave or I showed where I talked about the consumer driven data exchange so it's really the patient has the power and the government's made it very very clear that you as a patient if you want to get your data and now you can get it electronically or at least you're supposed to be able to Via the fire API and this is really an important detail because if you're an innovator in the space and you want to pull data from you know from one of your users um EHR you you now have the business rules to be able to do that so you have in theory you should be able to design something and with your users permission you should be able to or they should be able to pull the data on your behalf and I mean to help them ultimately I hope that answers your question I don't know Brian if you have anything to add I totally agree I think if it's there to protect patients and yes there is bureaucracy like in anything when you have regulations but you know they're surmountable for the entrepreneur and for people working in this space it's a lot about familiarity and remember HIPAA is not it's it's a comedy this is where it's challenging right it's a combination of you have to have processes in place and certain software standards so that's what part of what makes it complex uh but I agree with you uh Oliver it's it's you know I think patients are in control I was talking with a company called Crescendo Health where they're trying to enable this uh where people have control and then if they want to provide their data for research or whatever they can do it so we're making inroads it's it's a slow process yeah I'll also just say that for HIPAA it's very much a shared responsibility meaning like if I'm a startup and I'm you know and I want to make sure I'm HIPAA compliant it's a shared responsibility meaning I as Brian Brian said I have to have certain processes and procedures in place in terms of you know making sure that everyone is trained on how to handle the data um we need to make sure that we have a role well-defined roles in access controls to the data you need to make sure to have a business associates agreement in place with all your contract you know server providers and database providers so it's it's a kind of a shared responsibility between you and your partners um you can't just buy it necessarily so it's it's a complex it's not as complex as it seems I mean I'll I'll just put it that way it's just more of a process and procedure um thing so all right there was a question about um as far as sharing data from the patient isn't there a risk of patients misreporting their condition or their information yeah Brian I don't I mean I can start there again yeah go ahead I think yeah okay yeah I know 100 I think I'll give you a great example the Apple watch irregular Rhythm notification 100 it never calls an afib or an irregular Rhythm from just one one Rhythm detection it needs to read I believe it's I don't I may misspeak here but it's at least five separate readings five separate consecutive readings that need to be consistent before the confidence you know their confidence goes up to make a call like that this isn't a regular rhythm because you're right in the real world when you're talking when you have sensors you're going to have artifact you know did you bang your arm against something or are you walking are you jumping so these these are real that's a really good question um from a sensor standpoint now whether a patient puts in the right data or not uh you know that I agree that's something that um you almost have to have like a double triple check you have to ask a question maybe in three different ways to make sure that the answer is very consistent I don't know Brian if you have anything else yeah I think oh sorry I think um yeah it's it's I mean it's constant about race this is kind of even separate from digital Health right we patients can tell us whatever and and I think we're as Physicians are trained to really well we're supposed to get an appropriate history and physical and really assess the real life part of that's assessing the reliability of course the default is to trust what the patient's doing um you know we're there for the patient you can't always be in a situation where you're not trusting uh what the patient's telling you uh but you know you want to verify especially if it's something you're going to hinge your opinion on but we do that even for other things like pathology right if somebody comes in with a cancer uh we at Stanford have asked them to bring their get their slides and their pathology slides and our Pathologists will then look at them just to confirm the diagnosis so you know there are certain crucial times where that data and verify today is important sometimes it's not so I I think it's an issue but I don't think it's a issue Central to digital Health it's it's an issue just generally with information flow and health can you speak to access to these products or tools more Equitable but the design of them as well so localization multilingual I'll make a comment I think we would do a terrible job I'm the director of the center for Asian health research and education just from the language access point I think it's horrible you know when we when we have epic my health right I have you know we kind of buy this big compendium of pre-canned instructions for patients and I've had many patients tell me oh this looks like it was just translated directly it doesn't it's really lost a lot of this it's almost like they just took their English version and Google translated it and then just using my health right it's it's in English right and then you know changing the language and then there's of course digital health literacy uh so I think we're doing a terrible job I I'm not aware of I don't know Oliver if you are if there's any good system level efforts I think there's a smaller level and they're very much like Stanford we're trying to do better I just had a meeting with our um health patient experience people at the hospital trying to improve this for non-english speakers uh so to me it seems to be really done at the lower level the hospital and the clinic level I I don't know of any broader efforts to do this at least at the government level I don't know Oliver have you heard of it well I know I know um I know it's definitely in the in the radar or uh is because it is becoming more and more part of the requirements for uh certain grants I know the state of California for example the California Department of Aging just put out a huge RFP for um just training home care workers and part of it was it was very clear they uh it needed to be accessible um or accessibility was a big uh factor and that that speaks to the digital divide as well as literacy um and so on so I I think you know we're not great because you see the most implementation the greatest implementation is typically uh for those that can pay and that's the top of the wealth pyramid and so it's not necessarily Fair because the bottom of the wealth pyramid is often you know is often overlooked but I'll be honest in the last there's been a huge push around uh you know just innovating for the bottom uh of that wealth pyramid to make sure that more people can benefit uh from you know from all these Innovations but nothing um I just I want to just say that at least we're talking about it at least we're um we're you know thinking about it and they're definitely I mean it's very clear there's a digital divide there's a literacy divide that we need to address to make things more equitable I mean I'll give another quick I mean this is kind of tangentially directed I mean the CMS just last week expanded the um kind of the um the rule to for example we know that the postpartum uh African-American women have a much higher mortality rate than let's say white counterparts and it turned out when they did the research that a lot of this mortality postpartum came after 60 days and currently the federal federally mandated Medicaid coverage is only up to 60 days and they've because of this uh finding they expand they extended the federally mandated coverage for Medicaid for women up to a year and 40 of births in the U.S are are under Medicaid and most often those 40 percent or many of those women would lose their insurance after 60 days before this rule so there are you know there are efforts uh to provide continual support um you know when you're thinking or looking through the equity lens thank you um questions too with regard to kind of data privacy um let me put one here um and also access so actually first question um can you discuss the about future directions between uh interoperability between data from these Home Health devices and integrating these this data with existing EMR systems that's a tough one I mean I know I believe this is the case still I mean we have some very very we have few examples where we can actually write into the EHR but um we don't have I don't think we have a great system you know to take that data and to put it together intelligently um currently um for patients instead of in places such as Ochsner what they have done is they basically create reports because it's a lot of time you can imagine the time series data for example a watch or activity or something it's a lot of data and so they try to condense that data into reports that then you can click into from the EHR through a a hyperlink so that's what I've seen and these are through these dashboards and I know we even at Stanford they do they do that quite a bit for certain projects um but that's it's not definitely not a norm for these data streams to be integrated with the EHR I would say it's an exception but it can't be done and that's what fire is trying to imp is to enable yeah I agree with uh Dr alamio oh we just make a comment that in the cases where they are enabled like you know I'm a primary care doctor I get and I cover my colleagues and some colleagues are great about getting patients you know their devices connected and we get these reports and there you have these huge time time series data but the vast majority of people send nothing so it's amazing you know we see and I click and I click and it's like patient reported nothing and then you know again some of my colleagues are great and they've got like half their patients on this with high blood pressure and it's like click click click nothing nothing nothing nothing nothing nothing so even when it's enabled a lot of people are either not checking it or not sending it uh or there's some technical issues so so it's interesting I think there are multiple areas and I really agree I think Oliver I think you hit the nail on the head is this how do we intelligently use this right you know you ask any doctor they don't want more stuff in their inbox right um so you know how do we intelligently use this data you know how do we put in systems where we can do this and make it scalable where there's not necessarily always a human being like me covering people's boxes you know clicking through and and acknowledging them uh and then because otherwise we just end up going through this episodic care right this this encounter based care and it's sitting there but nobody's doing anything with the data so a lot of of interesting points with that challenge I would add as another really great insight for all successful programs I'll give you an example the VA has launched quite a huge preferred diabetic foot ulcer prevention there's a company called podometrics they have a smart mat it's like a scale and it does a heat generates a heat map when you step on it every day more than the technology this is what they've told us so the podiatrist at least they feel like they've seen better outcomes in patients who are part of these programs not necessarily because of the technology but because the technology connects them to a care coordinator who follows up on you know things so if if nothing else this technology if you can build it in so that it gives you easier connection to the health system and you're someone with a chronic condition that needs better monitoring oftentimes it's that human connection that you know is the magic sauce so I'll just I'll just say that as an Insight that's great you know my you know I've got another hat on is like medical Humanities and arts guy and yeah I mean all these tools are just to support the human interaction really at the end that's great because there's actually a question next about at the risk of digital Health further distancing patients from Physicians so I think you kind of answered that question in a way um right yeah it's a tool we it's like anything else some tools are good and some tools are bad you can use them inappropriately but you know it's I to my mind never going to replace the human interaction the goal would be to make it more efficient better higher yield uh where I'm not sitting there spending a lot of time you know trying to figure out somebody's insurance and what meds are covered right that's not a good use of my time uh I'd rather spend time to talk about what the patient wants to talk about yeah and Brian also another another really important point for successful programs that I've seen is is to um you know if you have you need to have some sort of a coordinator or someone to help you know engagement is really tough you said you had a few patients Brian that had zero engagement others said I had great engagement and I know from Ochsner again that when they they had a full-time coordinator who just responsible for pinging patients if they didn't see blood pressures coming in checking in you know oh we haven't seen a blood pressure from you today that that's really important for in successful programs because it's otherwise hard to get engagement for today this is also also um you know what is preventing State pharmaceutical companies from using this data that's being collected um to develop drugs for profit and do you have any thoughts on that you know it's funny I was at a talk for we have this there's this Bay Area in a medical informatics society and the the informatics fellows hold like a symposium twice a year and uh one year they had um uh the gentleman who's the head of the Mayo's digital Health uh basically yeah yeah used to be at Harvard and then went to Mayo and uh you know they are basically spent all this time anonymizing their entire Mayo health record for part of the goal is to you know for drug Discovery and to let this open and and uh I was kind of being provocative you know I like to poke the bear and I said I I send a question in and and the fellows were the fellows are moderating it much like Jackie you're moderating and I said hey well you know what do the patients get right and uh there are models out there I think that you know the correct venters working on this and you know the human genome Guy where patients will get paid based upon sharing their data using their data Mayo's response was you know kind of I was less enthusiastic it was like well you know this is helps everybody right it's kind of the general well this is research this also helps everybody but you know it's kind of different I I my I come down in that well if you you kind of signed this blanket statement oh you can use my stuff you know there's kind of uh not a sort of Damocles but there's a leverage there right you're like well I want to get my care I'm here at Mayo or wherever at Stanford wherever to get care so I'm just going to sign whatever because I need to see the doctor right as opposed to you're in a clinical trial somebody specifically explaining to you what's the risk and benefit and who's the benefit so so I'm I'm with you there I think patients should be somehow I don't know if anybody's figured that out compensated for use of their data I mean you look at companies like Google right they have access to hundreds of millions of people's records right it's quite scary right um I don't know if I trust Google with that data uh even though they you know it's a company that's like don't do evil I'm like I want a company that does good not just doesn't do evil right so it's quite scary and I think that's quite concerning I'm not sure what to do about it yeah I would just add that there's I mean there are big companies billion dollar companies that were formed around this you know flat iron health for example was bought by Roche and what Flatiron did is they provided an electronic health record system for free to oncologists who were managing people with cancer and that then selling that data to Pharmacy or pharmaceutical companies and Roche just went out went out and bought them I think it was I can't remember how many billion but it was definitely over a billion so it's very valuable it is an issue there's a great appetite for that data data is really the the oil you know for the future um right it needs to be refined to get all the insights thank you for that okay I think we actually went a little bit over so I think we're gonna wrap up the webinar today thank you for all the questions I know there are a lot of questions that um we didn't actually get to so um thank you for submitting those and um if you'd like to learn more actually from Dr Lynn or Dr Alami uh feel free to um check out their course which is digital Health product development um again you can click the QR code here you can visit us on Stanford online to enroll um and we definitely encourage you to check this out as well and a link to the recording of the session will be emailed to you within the next week or so so feel free to visit this content um again and once again thank you for joining us today we hope you have a great week and we hope to see you at our next session thank you so much for presenting to us today all right thanks thanks so much thank you everyone have a great rest of the day
2022-11-18