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	<title>Medical Devices - Medika Life</title>
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		<title>Wearable Tech Can Catch Health Issues Before Doctors</title>
		<link>https://medika.life/wearable-tech-can-catch-health-issues-before-doctors/</link>
		
		<dc:creator><![CDATA[Pat Farrell PhD]]></dc:creator>
		<pubDate>Wed, 20 Nov 2024 17:46:18 +0000</pubDate>
				<category><![CDATA[AI Chat GPT GenAI]]></category>
		<category><![CDATA[Digital Health]]></category>
		<category><![CDATA[Editors Choice]]></category>
		<category><![CDATA[Medical Devices]]></category>
		<category><![CDATA[Patricia Farrell]]></category>
		<category><![CDATA[technology]]></category>
		<category><![CDATA[Wearables]]></category>
		<guid isPermaLink="false">https://medika.life/?p=20485</guid>

					<description><![CDATA[<p>A simple digital health device might provide a sense of security, but are they reliable, and what do you need to know about them?</p>
<p>The post <a href="https://medika.life/wearable-tech-can-catch-health-issues-before-doctors/">Wearable Tech Can Catch Health Issues Before Doctors</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
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<p id="fe01">The physical body is the latest target of the digital revolution. There is little question that wearable technology is the next logical step in the development of individualized healthcare. Future predictions and technological advances make it a highly attractive area of investment and for consumer purchases. Currently, its&nbsp;<a href="https://kms-healthcare.com/blog/wearable-technology-in-healthcare/" rel="noreferrer noopener" target="_blank">predicted revenue in the healthcare industry will reach $69.2 billion by 2028.</a></p>



<p id="88fd">Top IT firms are racing to attract customers for their wearable tech advancements because of this promising future of the wearable business. Tech giants like&nbsp;<strong>Samsung, Apple, and Microsoft</strong>&nbsp;have released new products in recent years. And digital wearable health devices are showing promise in&nbsp;<em>managing chronic conditions, promoting preventative healthcare, and improving patient engagement</em>, according to research conducted in 2024.</p>



<p id="16c3">Improvements in sensor technology, AI integration, and data analysis are also&nbsp;<em>enabling more personalized and accurate health monitoring</em>. However, there are still issues with&nbsp;<em>data privacy, regulatory frameworks, and device validation</em>&nbsp;that need to be resolved before these devices can reach their full potential. But today wearable devices are adding a new layer of both protection and vulnerability to our health and our health records.</p>



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<p id="58cf">When it comes to&nbsp;<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC9330198/" rel="noreferrer noopener" target="_blank">diagnosing and monitoring individuals</a>, wearables might be useful. Worldwide health systems, like the National Health Service in England, have acknowledged the potential of wearable technology to aid with health care, and this acknowledgment has earned them a spot in the common strategic Long Term Plan. Wearables, however, are not just for patients’ specialized medical gadgets. For customers who are concerned about their health, top IT companies have started investigating wearable health devices.</p>



<p id="066c">With its January 2019 launch, the “NHS Long Term Plan”&nbsp;<em>lays out NHS England’s goals for healthcare over the next decade,</em>&nbsp;including how the organization will spend NHS funds to enhance patient care and health outcomes throughout the country.</p>



<p id="ffd5">According to a large body of research,&nbsp;<em>wearables can help people take charge of their health</em>&nbsp;by facilitating&nbsp;<em>self-diagnosis, behavior modification, and monitoring</em>. If the technology is to be used widely, it requires more promotion and support from providers to encourage uptake; more short-term investment to upskill employees, particularly in data analysis; and overcoming barriers to use,<em>&nbsp;especially by improving device accuracy</em>, are all factors that will contribute to greater wearable adoption and engagement.</p>



<p id="58d0">Participatory health informatics (PHI) means considering the role of technology in assisting individuals with self-management and decision-making by also improving health literacy and the physician-patient relationship so that individuals can become more involved in the aspects of their health and care.</p>



<p id="7da4">Historically, research in the PHI field has predominantly been&nbsp;<em>based on social media and internet-based applications,</em>&nbsp;with&nbsp;<a href="https://pubmed.ncbi.nlm.nih.gov/33622168/" rel="noreferrer noopener" target="_blank">patient empowerment having been identified as the most common theme&nbsp;</a>in this body of research. However, wearables are just beginning to be considered as part of PHI given recent technological advancements. Therefore, similar research is now required to examine whether wearables can empower individuals in ways similar to those regarding domains such as&nbsp;<em>self-management, decision-making, and the physician-patient relationship.</em></p>



<p id="7847">And the&nbsp;<a href="https://pubmed.ncbi.nlm.nih.gov/33622168/" rel="noreferrer noopener" target="_blank">inclusion of patient empowerment</a>&nbsp;must also be calculated and addressed in a world where an almost collegial relationship is formed between patient and physician. This will be a major change from our past relationships where patients were poorly received once they began researching their illnesses on the Internet and questioned their healthcare provider. “<strong>Oh, you’ve been using Dr. Google, I see</strong>,” was a common put-down. Respect is receiving new consideration and pointing out our lapses in possible healthcare education and&nbsp;<em>sensitive training toward patients must be required</em>. Can challenging patients be acceptable, as formerly was the case?</p>



<p id="95a4">Remote patient monitoring using&nbsp;<a href="https://www.nature.com/articles/s41467-023-44634-9" rel="noreferrer noopener" target="_blank">wearables is becoming more important</a>&nbsp;in light of the growing provider shortages that exacerbate geographically based disparities.</p>



<h2 class="wp-block-heading" id="8c9d">Where Do We Need Wearable?</h2>



<p id="c4b1">One area of intense interest is related to&nbsp;<a href="https://www.nature.com/articles/s41746-024-01268-5" rel="noreferrer noopener" target="_blank">patients with potential cardiac issues</a>&nbsp;and here we note that much is yet to be accomplished for these patients. Only&nbsp;<strong>eight studies of the 31,12 papers</strong>&nbsp;retrieved from a systematic search were randomized controlled trials. The research was mostly focused on&nbsp;<em>consumer-grade wearables that were modified</em>&nbsp;to monitor heart failure (HF). The majority of these studies were conducted in the feasibility testing phase. Out of all the wearables that were mentioned,&nbsp;<strong>only two were approved by the FDA</strong>&nbsp;for HF RM (remote monitoring). A major obstacle to wearables’ incorporation into HF therapy is the&nbsp;<em>lack of convincing evidence</em>&nbsp;regarding their actual influence on HF management. This must be a concerning issue.</p>



<p id="42db"><a href="http://the%20complex%20and%20sometimes%20fatal%20syndrome%20known%20as%20heart%20failure%20(hf)%20is%20marked%20by%20high%20expenses,%20low%20functional%20capacity%20and%20quality%20of%20life,%20and%20high%20rates%20of%20morbidity%20and%20mortality.%20over%2064%20million%20individuals%20across%20the%20globe%20are%20impacted%20by%20hf.%20as%20a%20result,%20reducing%20its%20monetary%20and%20social%20impact%20has%20risen%20to%20the%20status%20of%20a%20top%20public%20health%20concern%20on%20an%20international%20scale./" rel="noreferrer noopener" target="_blank">High expenses, low functional capacity and quality of life, and high rates of morbidity and mortality</a>&nbsp;marked the complex and sometimes fatal syndrome known as heart failure. High expenses, low functional capacity and quality of life, and high rates of morbidity and mortality mark the complex and sometimes&nbsp;<strong>fatal syndrome known as heart failure (HF)</strong>.&nbsp;<strong>Over 64 million individuals across the globe are impacted by HF&nbsp;</strong>and we do not truly know the total number because not everyone with potential HF has been identified<strong>.&nbsp;</strong>As a result, reducing its monetary and social impact has risen to the status of a top public health concern on an international scale. Therefore, this should be one of the aims of wearables — helping to reduce mortality.</p>



<p id="4bab">But digitals have a whole host of potential uses currently that include&nbsp;<em>fall detection, glucose monitoring, activity monitoring (steps tracking), sleep quality, blood pressure monitoring, and potentially high-risk pregnancies.</em></p>



<h2 class="wp-block-heading" id="2f9b">Unaddressed Issues of Wearables</h2>



<p id="3369">Concerns about privacy and data sharing&nbsp;<strong>are only two&nbsp;</strong>of the many hazards and difficulties linked to wearable technology. The literature has mainly&nbsp;<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC9931360/" rel="noreferrer noopener" target="_blank"><em>addressed technological or ethical concerns</em></a>, treating them as distinct domains of study; nevertheless, wearables’ potential to enhance biomedical knowledge acquisition, development, and application has received scant attention.</p>



<p id="ca02">Three areas that have been inadequately studied include&nbsp;<strong>screening, detection, and prediction.</strong>&nbsp;Screening involves searching through datasets obtained by monitoring for particular diseases and the people linked to them. Passive sensors that monitor things like&nbsp;<em>motion, steps, light, pressure, sound,</em>&nbsp;etc. are typically the basis of wearables used for this purpose.</p>



<p id="80f6">One application of wearable technology is screening for&nbsp;<strong>sleep apnea</strong>&nbsp;by tracking the wearer’s heart rate and breathing patterns while they sleep. Detection is a process that is closely connected to screening. It is common practice to employ wearables to detect conditions and notify individual users when monitoring particular conditions in populations.&nbsp;<strong>Detection involves looking for patterns</strong>&nbsp;and features in the data gathered from wearable monitoring devices that could be indicative of certain medical disorders. Once we have this data, the possibility of greater detection of issues may emerge.</p>



<p id="792f">It is still&nbsp;<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC7263786/" rel="noreferrer noopener" target="_blank">very difficult to predict clinical outcomes</a>&nbsp;following hospital discharge. There has been little success with strategies aimed at predicting and preventing death after discharge, readmissions, and trips to the emergency department (ED). Early interventions on modifiable risk variables might minimize morbidity, death, readmissions, and emergency department visits if predictive models could be improved. Wearable technology can monitor activity levels, sleep patterns, and tachy- or bradyarrhythmias, some of the modifiable risk factors for these clinical outcomes. Wearable digital devices might make significant differences in the ability to predict future health issues.</p>



<p id="524a">It has been shown that using&nbsp;<a href="https://dl.acm.org/doi/10.1145/2971648.2971750" rel="noreferrer noopener" target="_blank">more aspects of complex data from wearable</a>&nbsp;technology would most likely enhance prediction models. One study that made use of 89 Fitbit data characteristics had an&nbsp;<strong>88.3 percent success rate</strong>&nbsp;in predicting hospital readmission. Compared to other models, theirs&nbsp;<em>performed far better</em>&nbsp;in predicting readmission&nbsp;<em>using typical retrospective clinical data.</em></p>



<p id="c241">Are digital, non-invasive wearables a viable and important contribution to healthcare now and in the future? Unquestionably, they are providing information as a continuous monitoring system in real-time and can prevent fatalities. The cost of the devices, availability, and insurance reimbursement will undoubtedly factor into how many patients can avail themselves of this technology. Lower-income patients and those in health deserts will be less likely to have access to them.</p>
<p>The post <a href="https://medika.life/wearable-tech-can-catch-health-issues-before-doctors/">Wearable Tech Can Catch Health Issues Before Doctors</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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		<post-id xmlns="com-wordpress:feed-additions:1">20485</post-id>	</item>
		<item>
		<title>Clinical Trials As a Care Option – the Time is Now</title>
		<link>https://medika.life/clinical-trials-as-a-care-option-the-time-is-now/</link>
		
		<dc:creator><![CDATA[Irfan Khan MD]]></dc:creator>
		<pubDate>Wed, 04 Jan 2023 23:22:16 +0000</pubDate>
				<category><![CDATA[Digital Health]]></category>
		<category><![CDATA[Diseases]]></category>
		<category><![CDATA[Editors Choice]]></category>
		<category><![CDATA[General Health]]></category>
		<category><![CDATA[Healthcare Policy and Opinion]]></category>
		<category><![CDATA[Mental Health]]></category>
		<category><![CDATA[Public Health]]></category>
		<category><![CDATA[TeleHealth]]></category>
		<category><![CDATA[Biotech]]></category>
		<category><![CDATA[Clinical Trial Investigators]]></category>
		<category><![CDATA[Clinical Trials]]></category>
		<category><![CDATA[Decentralized Clinical Trials]]></category>
		<category><![CDATA[Health Disparities]]></category>
		<category><![CDATA[Irfan Kahn MD]]></category>
		<category><![CDATA[Medical Devices]]></category>
		<category><![CDATA[mental health]]></category>
		<category><![CDATA[Pharma]]></category>
		<category><![CDATA[Racial Equity]]></category>
		<guid isPermaLink="false">https://medika.life/?p=17149</guid>

					<description><![CDATA[<p>Creating more effective, safer medicines starts with empowering new communities to join in on clinical research</p>
<p>The post <a href="https://medika.life/clinical-trials-as-a-care-option-the-time-is-now/">Clinical Trials As a Care Option – the Time is Now</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
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<p>When patients participate in clinical trials, there is the promise their participation could help <em>all</em> of us live longer, healthier lives by playing a critical part in bringing a new treatment, vaccine, or device closer to FDA approval. But clinical research also has the potential to provide participants with a novel care option if they are living with chronic diseases that are the focus of new research. Unfortunately, patients who might benefit directly are too often unaware that clinical trials are happening in the first place.</p>



<h2 class="wp-block-heading"><strong>The current clinical trial landscape</strong></h2>



<p>In 2020, <a href="https://hints.cancer.gov/docs/Briefs/HINTS_Brief_48.pdf">41% of Americans</a> reported not knowing anything about clinical trials or their potential as a treatment option. That’s a huge percentage of the U.S. population that isn’t participating in research that could help them address serious health issues they’re facing. To correct this, we need an ecosystem-wide effort aimed at building awareness for patients, their advocates, and physicians.</p>



<p>Essential to this effort is a concerted, intentional approach to increase clinical trial access for communities historically underrepresented in clinical research. <a href="https://clinicaltrials.gov/ct2/results/map?cond=&amp;term=&amp;cntry=&amp;state=&amp;city=&amp;dist=&amp;recrs=a">While there are currently 24,602 clinical trials recruiting participants in the U.S.,</a> 50% of FDA trials are conducted in only 1-2% of zip codes in the U.S., which means that millions of patients are shut out of research based solely on their geographic location or socioeconomic status. This primarily impacts people of color and those living in rural communities.</p>



<h2 class="wp-block-heading"><strong>Benefits of clinical trials</strong></h2>



<p>It’s a status quo begging to be reimagined. Drugs can have a <a href="https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.61?casa_token=TsCaY6vC4pEAAAAA%3A0FjmuKiGUEbzvSvXC1LnmIpG9reMTMEeQ9VdjeszKoOwHzhBOrNuoipu2MJLatShuoGtQGW1aCI">different effect</a> on patients depending on their race and ethnicity, which emphasizes the importance of increasing diversity in trial participants to ensure safety and efficacy of therapeutics. And, even though every American who has taken over-the-counter or prescription medications has benefitted from a clinical trial, <a href="https://hints.cancer.gov/docs/Briefs/HINTS_Brief_48.pdf">only 8.9%</a> of us report being asked to participate in one.</p>



<p>Beyond the benefits to drug development, participation in clinical trials can provide participants with important advantages too. Patients can gain access to new treatments before they become widely available. They also receive regular, careful medical attention from physicians and other care professionals on the trial’s research team.</p>



<p>For some patients, participation can result in cures; one recently reported <a href="https://www.nytimes.com/2022/06/05/health/rectal-cancer-checkpoint-inhibitor.html">trial</a> that evaluated a colorectal cancer treatment remarkably led to remission for every patient involved. Other recent trials have helped shrink tumors for patients with <a href="https://healthblog.uofmhealth.org/cancer-care/how-a-clinical-trial-expanded-options-for-a-patient-a-rare-cancer">bile duct cancer</a> and provided relief for those dealing with chronic <a href="https://www.washingtonpost.com/wellness/2022/09/12/ketamine-therapy-explained/">depression</a>. But clinical research provides no benefits if patients don’t know about them – and before we solve the participation challenge, we have to solve the awareness challenge.</p>



<h2 class="wp-block-heading"><strong>Building networks has far-reaching effects</strong></h2>



<p>To raise awareness of clinical trials and encourage involvement, we must start by expanding the network of potential clinical trial sites and physicians who administer them. Too often, the community health centers that serve <a href="https://www.nachc.org/about/about-our-health-centers/#:~:text=Today,and%20urban%20communities%20across%20America.">over 30 million Americans</a> – including many members of the underrepresented groups that biopharma companies are seeking to reach and include – are simply left out of the equation. </p>



<p>A positive step forward would be to build up a new, expansive and inclusive network of trial sites and clinical trial investigators who can more effectively bring clinical research as a care option to their patients and communities. No one company can do this alone, but, as an industry working collectively, this is an achievable goal.</p>



<p>Additionally, digital technologies can be used to identify and provide information on clinical trials to people with particular diseases who may benefit most from trial participation, regardless of location. These technologies can also be leveraged to assist in communication throughout the trial process in order to enhance site design and patient experience, helping to boost engagement and prevent dropouts. &nbsp;</p>



<p>Too many Americans don’t know enough about clinical trials to evaluate and choose participation, but we can take steps to solve that problem. We can work together across disciplines to identify and create sites in underrepresented communities, involve new physicians more directly to reach patients and encourage their involvement, and seek patient engagement and feedback throughout the trial process to enhance their experience and encourage future participation more effectively. </p>



<p>By empowering new communities to join in on clinical research, we can reach more patients to offer clinical research as a care option – and at the same time, enlist their help in creating more effective, safer medicines for those who will need them to live longer, healthier lives.</p>
<p>The post <a href="https://medika.life/clinical-trials-as-a-care-option-the-time-is-now/">Clinical Trials As a Care Option – the Time is Now</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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		<post-id xmlns="com-wordpress:feed-additions:1">17149</post-id>	</item>
		<item>
		<title>The Medical Device That May Lead to Harm in People of Color</title>
		<link>https://medika.life/the-medical-device-that-may-lead-to-harm-in-people-of-color/</link>
		
		<dc:creator><![CDATA[Pat Farrell PhD]]></dc:creator>
		<pubDate>Tue, 13 Dec 2022 14:51:01 +0000</pubDate>
				<category><![CDATA[Cardiovascular]]></category>
		<category><![CDATA[Diabetes]]></category>
		<category><![CDATA[Digital Health]]></category>
		<category><![CDATA[Diseases]]></category>
		<category><![CDATA[Editors Choice]]></category>
		<category><![CDATA[For Doctors]]></category>
		<category><![CDATA[General Health]]></category>
		<category><![CDATA[Healthcare Policy and Opinion]]></category>
		<category><![CDATA[Public Health]]></category>
		<category><![CDATA[Type 1 Diabetes]]></category>
		<category><![CDATA[Type 2 Diabetes]]></category>
		<category><![CDATA[BIPOC]]></category>
		<category><![CDATA[BMI]]></category>
		<category><![CDATA[BP]]></category>
		<category><![CDATA[Medical Devices]]></category>
		<category><![CDATA[Patricia Farrell]]></category>
		<category><![CDATA[People of Color]]></category>
		<category><![CDATA[Pulse Ox]]></category>
		<guid isPermaLink="false">https://medika.life/?p=16767</guid>

					<description><![CDATA[<p>Testing medical equipment is aimed at ensuring that it applies to every patient, regardless of their race, but one piece missed the mark.</p>
<p>The post <a href="https://medika.life/the-medical-device-that-may-lead-to-harm-in-people-of-color/">The Medical Device That May Lead to Harm in People of Color</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p id="278b">Several biological indicators used to assess our physical health have come into question;&nbsp;<a href="https://www.mdanderson.org/publications/focused-on-health/5-questions-about-bmi.h15-1592991.html" rel="noreferrer noopener" target="_blank">BMI</a>,&nbsp;<a href="https://www.medpagetoday.com/primarycare/preventivecare/102113?xid=nl_mpt_DHE_2022-12-10&amp;eun=g444003d0r&amp;utm_source=Sailthru&amp;utm_medium=email&amp;utm_campaign=Weekly%20Review%202022-12-10&amp;utm_term=NL_DHE_Weekly_Active" rel="noreferrer noopener" target="_blank">BP</a>,&nbsp;<a href="https://health.clevelandclinic.org/body-temperature-what-is-and-isnt-normal/" rel="noreferrer noopener" target="_blank">temperature</a>, and&nbsp;<a href="https://www.healthline.com/health/normal-blood-oxygen-level" rel="noreferrer noopener" target="_blank">oxygen readings</a>. All of them may need revamping or a rethinking of ranges rather than rigid numbers, but we question one because of the device used to measure it.</p>



<p id="782b">Racial bias prevents many people from&nbsp;<a href="https://www.brookings.edu/articles/unequal-opportunity-race-and-education/" rel="noreferrer noopener" target="_blank">attending adequate schools</a>, entering promising careers, and accessing&nbsp;<a href="https://www.ncbi.nlm.nih.gov/books/NBK568721/" rel="noreferrer noopener" target="_blank">adequate healthcare</a>. This bias also affects where they can&nbsp;<a href="https://www.wise-geek.com/what-is-housing-bias.htm" rel="noreferrer noopener" target="_blank">find suitable housing</a>, and that&nbsp;<a href="https://pubmed.ncbi.nlm.nih.gov/18080206/" rel="noreferrer noopener" target="_blank">housing may contribute to health difficulties</a>&nbsp;brought on by pollution or vermin infestation. The situation, undeniably, is untenable, and anyone who believes in human rights will find each of these impediments anathema.</p>



<p id="f376">All the above is clear, but taking the situation two steps further will reveal the hidden extent of the potential damage raining down on anyone who is a victim of this bias. And, most disturbing, this further damage to health happens in the medical realm.</p>



<p id="2433"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6352250/" rel="noreferrer noopener" target="_blank">Socioeconomic factors</a>&nbsp;lead to health risks such as asthma, and the need for ongoing, accurate treatment for asthma is mostly with inhalers. The condition is so severe that frequent emergency treatment is sought.&nbsp;<a href="https://www.medicalnewstoday.com/articles/asthma-in-african-americans#risk-factors" rel="noreferrer noopener" target="_blank"><em>Compared with white people</em></a><em>&nbsp;with asthma, African American people with asthma are&nbsp;</em><a href="https://www.aafa.org/wp-content/uploads/2022/08/asthma-disparities-in-america-burden-on-racial-ethnic-minorities.pdf" rel="noreferrer noopener" target="_blank"><em>five times</em></a><em>&nbsp;more likely to visit the emergency room for symptoms.</em></p>



<p id="cfc9">One of the inhalers of choice for asthma is&nbsp;<a href="https://medlineplus.gov/druginfo/meds/a682145.html" rel="noreferrer noopener" target="_blank">albuterol</a>, and here, again, there is a problem with treatment. A study of over 1,400 children revealed a&nbsp;<a href="https://www.atsjournals.org/doi/10.1164/rccm.201712-2529OC" rel="noreferrer noopener" target="_blank">genetic lack of appropriate response</a>&nbsp;to this drug in some patients. And problems in sampling were apparent.&nbsp;<em>We and others have documented the implications and challenges posed by the lack of non-European study populations in&nbsp;</em><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4679830/" rel="noreferrer noopener" target="_blank"><em>biomedical research</em></a><em>.&nbsp;</em>Sampling bias is at the heart of one major problem in device engineering.</p>



<p id="ddcd">Once asthma treatment is sought, there still needs to be a resolution to the underlying measurement problem. While in the ER, how is the oxygen level of these patients determined? The usual initial route is to get a quick level using an oximeter slipped on a finger. It’s a rapid and supposedly accurate measure of how much oxygen the patient has in their blood; vital information.</p>



<p id="2e0f">Who questions the oximeter readings? The assumption is that the task is accurate because the device is FDA approved, made by a reputable company, and has been used for years in hospitals. But that conclusion is patently false.</p>



<p id="7b9f">The validity of the readings was made&nbsp;<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4803087/" rel="noreferrer noopener" target="_blank">primarily on persons of European descent.&nbsp;</a>How accurate would they be on anyone who did not meet that criterion? The answer would seem obvious.</p>



<p id="708f"><a href="https://www.statnews.com/2022/11/01/pulse-oximeters-inaccuracies-fda-scrutiny/" rel="noreferrer noopener" target="_blank"><em>Studies dating back to 2005</em></a><em>&nbsp;show pulse oximeters tend to overestimate the amount of oxygen a patient with darker skin may actually have in their blood. It’s simple physics: Melanin in skin absorbs some of the light the devices analyze to make their readings. The darker the skin, the more melanin there is, and the less light passes through.</em></p>



<p id="9035">If the readings are wrong, how does that have an impact on treatment? Again, no question that there is a bias in oxygen levels leading to changes in medical care.</p>



<p id="e14a">The&nbsp;<a href="https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication" rel="noreferrer noopener" target="_blank">FDA issued an alert on oximeters</a>, but did everyone dispose of their older, inaccurate devices in healthcare and the home? Other factors affect these readings, including&nbsp;<em>poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish.</em></p>



<p id="5fb9"><a href="https://www.hpl.hp.com/hpjournal/pdfs/IssuePDFs/1976-10.pdf?source=aw&amp;subacctid=78888&amp;subacctname=Skimlinks&amp;adcampaigngroup=561219jumpid=af_gen_nc_ns&amp;utm_medium=af&amp;utm_source=aw&amp;utm_campaign=Skimlinks&amp;campaignID=&amp;utm_content=78888_Skimlinks_&amp;awc=7168_1666793137_ec246ccc86e609f77284ce2fe3373c90" rel="noreferrer noopener" target="_blank">NASA had developed guidelines</a>&nbsp;and devices for more accurately measuring blood oxygen, but the corporation involved in it changed its marketing direction and the device was dropped.</p>



<p id="22db">We know that the disturbing use of&nbsp;<a href="https://link.springer.com/article/10.1007/BF00858362" rel="noreferrer noopener" target="_blank">oximeters tested in Japan</a>&nbsp;(with a relatively homogenous population) may lead to delays in treatment in persons with darker skin. How is this permissible? It’s not, and the NASA devices should be considered again.</p>
<p>The post <a href="https://medika.life/the-medical-device-that-may-lead-to-harm-in-people-of-color/">The Medical Device That May Lead to Harm in People of Color</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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		<post-id xmlns="com-wordpress:feed-additions:1">16767</post-id>	</item>
		<item>
		<title>Policies and Policing Didn&#8217;t Stem Opioid Abuse – Can Tech Be A Solution?</title>
		<link>https://medika.life/policies-and-policing-didnt-stem-opioid-abuse-can-tech-be-a-solution/</link>
		
		<dc:creator><![CDATA[Gil Bashe, Medika Life Editor]]></dc:creator>
		<pubDate>Wed, 21 Sep 2022 01:57:56 +0000</pubDate>
				<category><![CDATA[Addiction]]></category>
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		<guid isPermaLink="false">https://medika.life/?p=16285</guid>

					<description><![CDATA[<p>Medika Talks with Serial Health Tech Entrepreneur Jay Schiff About His Efforts to Unite Devices with Digital Health to Offer a New Pathway to Patient Care</p>
<p>The post <a href="https://medika.life/policies-and-policing-didnt-stem-opioid-abuse-can-tech-be-a-solution/">Policies and Policing Didn&#8217;t Stem Opioid Abuse – Can Tech Be A Solution?</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
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<p>Remember before COVID jumped onto the front pages, the biggest epidemic was opioid abuse?&nbsp; It remains a major killer.&nbsp; On average, annual overdose deaths exceed&nbsp;100,000 people, and a record 18.4 million people are addicted, with Black, American Indian and rural people most affected. If we can’t mandate workable solutions by Federal or State policy, can health tech and digital health offer a solution?</p>



<p>Opioid addiction and pain relief require massive health professional, patient, payor, policy and product innovator engagement.&nbsp; The Food and Drug Administration has launched a new Overdose Prevention Framework, targeting unnecessary prescriptions, prolonged prescribing and counterfeit drugs, and supporting new treatments for substance use disorders and physician education.</p>



<p>But how can innovation be part of the public health and policy solution to create a balance between the imperative to monitor and reduce addiction risks?&nbsp; How can innovation be part of the solution if regulators and payers do not partner with innovators?</p>



<p><em>Medika Life</em> Editor-in-Chief Gil Bashe talks with serial entrepreneur and investor <a href="https://www.linkedin.com/in/jayschiff1/">Jay Schiff</a>, co-founder and CEO of <a href="https://www.addinextech.com/">Addinex Technologies, Inc</a>., a young company focusing on one of the nation’s most pressing issues – opioids – to explore the possibilities and opportunities.</p>



<p>Jay is a Wall Street veteran who has invested more than $1 billion in small and mid-sized businesses. He has managed private investment businesses for Merrill Lynch, a $1 billion private equity firm, and a venture-backed finance company. Jay earned his BA in Economics from Cornell University and an MBA in Finance from New York University.</p>



<p><em>[Medika Life and FINN Partners have no business ties to Addinex Technologies.&nbsp; This interview focuses on the critical role health innovators serve in exploring new paths to long-standing problems unaddressed.]</em></p>



<p><strong>Gil Bashe: I understand you have engineered a dispensing system for opioids. Is that correct?</strong></p>



<p><strong>Jay Schiff</strong>: &nbsp;Yes. I read several articles on the opioid epidemic and it struck me as odd that controlled substances like opioids were highly regulated and monitored until they got to the patient. From production to the pharmacy, they are treated as dangerous, with a high potential for <a href="https://www.deadiversion.usdoj.gov/schedules/">abuse</a>, but they were being dispensed with the same level of protection as Tylenol.</p>



<p>The child cap was invented in 1967. That’s more or less where the innovation stopped in terms of keeping the wrong people from accessing medication. And then what do you do with excess meds if you aren’t supposed to flush them down the toilet or throw them in the garbage, given 3.3 billion excess pills prescribed a year?</p>



<p><strong>Bashe: The pill mills were, at first, just distributors filling the demand of the local marketplace of pharmacies. It’s sad how many people misuse opioids, how many people are addicted, and how many people tragically die each year. It’s one of the most significant causes of death in the United States. We can deal with this from a legal standpoint; we can deal with this from a policy standpoint; we can deal with this from an oversight standpoint, governance standpoint &#8211; you’ve chosen to deal with this from an engineering standpoint.</strong></p>



<p><strong>Schiff:</strong> Some things have been done from a legal and prevention standpoint. Certain states have limitations on initial opioid prescriptions – in New York; you can only get a seven-day supply. New Jersey is five days.</p>



<p>I talked to a doctor about that, and they said that&#8217;s not a limitation. If you prescribe a patient two pills every four hours, that&#8217;s 12 pills per day. Over seven days, that’s 84 pills: not much of a limitation. The reality is that doctors overprescribe opioids through no fault of their own.</p>



<p><strong>Bashe: But we know that’s because many patients are in pain, and obviously, the doctors don&#8217;t want them to be in pain. But they also lack data.</strong></p>



<p><strong>Schiff</strong>: &nbsp;Doctors don&#8217;t want their patients to be in pain, but does that mean they should give their patients 30 or even 90 pills? They can’t make an informed decision because that usage and pain level data is unavailable. Believe me. I searched everywhere.</p>



<p>If colleagues are prescribing 30 pills because they think that&#8217;s the correct number based on experience, that suddenly becomes the basis by which everyone prescribes.</p>



<p>But it&#8217;s not the correct method because we already know that doctors overprescribe after surgery, on average, by 70%, leading to 3.3 billion excess pills out there.</p>



<p>Good data is not available. The CDC put out guidelines in 2016. They&#8217;re now going back to the drawing board and coming up with updated guidelines. Again, it’s not based on actual usage data from the hundreds of millions of annual prescriptions; if it is based on some data, it’s just a tiny percentage of the whole picture.</p>



<p>Pain levels are also important. We did a study with Columbia University Medical Center where patients were asked, “What&#8217;s your pain level on a scale of zero to 10?” If their pain was a self-reported four or below, our app would automatically send them a message that their doctor would like them to switch to over-the-counter medication. At no time would we limit access, so the patient had no incentive to lie. We barely had any usage at those pain levels.</p>



<p>This feedback is essential because stats have shown that the longer you&#8217;re initially on opioids, the more likely you will become dependent on them. We can shorten that duration and therefore minimize the risk of dependency.</p>



<p>Opioids are supposed to be reserved for people suffering from severe pain. Other countries don&#8217;t use the same number of opioids as we do here. So, I think that data will help doctors more accurately prescribe and patients understand the risks of taking opioids for moderate pain versus switching to an OTC painkiller.</p>



<p><strong>Bashe: Your dispenser system is password protected. The patient has a unique passcode for each dose they enter to get the medication dispenser as prescribed. How does that help? In other words, what’s to stop a cancer patient from accessing their meds and simply giving them away to other people?</strong></p>



<p><strong>Schiff</strong>: In its simplest form, you can think of our dispenser as a speed bump. If the prescription is one pill every four hours, the patient could put the code in, get the dose, set it aside, and wait four hours for each dose. That is a tedious way to collect the medication for diversion. Worst case scenario, they’re back to where they started since there are currently no protections.</p>



<p><strong>Bashe: Let me clarify – you’ve developed a specially engineered pill, tablet, or capsule container, correct?</strong></p>



<p><strong>Schiff:</strong> Yes, and we’ve patented it. It’s entirely mechanical, and keeping the price as accessible as possible was essential. It can&#8217;t be zero, but we can get it out there to as many people as possible and then collect enough data to enable doctors to determine, “Here is the right amount to prescribe.”</p>



<p>Once we have enough data, a doctor can see, “I have a male patient between the ages of 20 and 30 weighing between 160 and 190 pounds. He’s had surgery to repair a torn ACL, and I want to prescribe him 10 milligrams of oxycodone every 4-6 hours a week.”</p>



<p>We can produce a graph of what similar patients have taken, and based on that information, combined with how similar patients have reported their pain level –&nbsp; – the doctor can determine how much to prescribe. The doctor can always choose another amount, but they will have access to objective data to decide the right amount for their patient.</p>



<p><strong>Bashe: And the dispenser itself is locked. In other words, the pills are placed in the dispenser and closed at the pharmacy. They are only accessible by way of the timed passcode, which releases a drug based upon the indication of use, according to the physician’s recommendation.</strong></p>



<p><strong>Schiff:</strong> Correct. It doesn&#8217;t automatically unlock every four hours, for example. The patient gets the unique code for that individual dose in the app, and they can’t get the next dose code until it’s been four hours and it’s time for that dose.</p>



<p>One important distinction for those taking opioids is that those drugs are not ones of adherence. They should be taken as needed, but the goal is to reduce the amount. That’s unlike many other drugs, where you want to keep them on a set schedule.</p>



<p>We can accommodate both, but for opioids, we don&#8217;t want to send reminders to take them when they are not necessarily needed. We want patients to use the app to request access when pain levels warrant another dose, and if the time is appropriate per the prescription, it will give them the code.</p>



<p><strong>Bashe: So, this is not just a one-time code for a patient. It’s a one-time dose</strong> <strong>passcode, assuming pills are left in the dispenser.</strong></p>



<p><strong>Schiff</strong>: Yes. Releasing one dose at a time has multiple benefits. It makes overdose more difficult because patients can die if they take too many opioids at once. Tragically, we have a family friend who died after an overdose following major surgery. Also, the individual dose codes keep other people out of your medicine. Even if the interloper figures out a code, they can only access one dose.</p>



<p>Another significant benefit is that the patient must engage with the app to get each dose. This allows the app to provide education and collect information to help with their treatment and future patients. Many app-only solutions suffer from poor engagement with the app, but that is not a problem with our system.</p>



<p><strong>Bashe: And is it purchased by pharmacy chains or drug manufacturers? Who is the customer for your dispensing system?</strong></p>



<p><strong>Schiff:</strong> The patient is the customer. We want to get it reimbursed by insurance, but we don’t have that today. It’s something we’re working on. The doctor prescribes and the patient receives it.</p>



<p><strong>Bashe: Often, when we look at growth hormone and the injector, or insulin and the injector, the therapy is generic. Insulin is generic; the injector is the brand, growth hormone is the generic the injector is the prescribed product. &nbsp;In this case, if someone prescribes a specific opioid, is the opioid generic, and the device itself is prescribed?</strong></p>



<p><strong>Schiff:</strong> Yes. It doesn&#8217;t go to any pharmacy; it has to be a pharmacy we’ve partnered with. They have to know not just to give a bottle with the pills but to get the pills in our system so we can monitor and dispense when appropriate, along with the disposal mailer.</p>



<p>When the patient is done taking their opioids, we remind them to return the dispenser with excess pills. The pharmacy doesn&#8217;t just send our device with the pills in it but also sends a DEA-approved disposal mailer.</p>



<p>After the pain is gone or low enough to use an OTC painkiller, the patient is asked to use the disposal mailer: close it up, drop it into a mailbox, or bring it to the post office. It goes back to a disposal company we have a partnership with, and upon receipt, they scan the mailer and a confirmation of receipt goes back into our app. Our partner then correctly disposes of the excess medication.</p>



<p>In the Columbia University Medical Center study I mentioned earlier, 80% of patients returned the device, representing 84% of excess pills. Compare that success rate with a Johns Hopkins meta-study, for example, where 4% and 9% of pills were correctly disposed of.&nbsp;</p>



<p><strong>Bashe: So the customer &#8211; the patient &#8211; receives the medication via Federal Express? “Sign here, please.”&nbsp; The patient signs for the drug in the device and has to activate it; in other words, after I’ve received the device and registered on the app, I’m now letting Addinex Technologies, and the doctor know the device is in my hands.</strong></p>



<p><strong>Schiff</strong>: Because it&#8217;s a controlled substance, delivery requires a signature. &nbsp;The patient then goes into the app, puts in their patient ID and the device ID, and if that matches up, the app gives them a unique code for each dose as it becomes available based on their prescription.</p>



<p>.<strong>Bashe: So you talked earlier about the challenge of payers. Is this because the device is not on the formulary with the medication? Payers are dealing with this challenge of effective pain management, and they get concerned about misuse, abuse, or addiction, putting them in the spotlight. What’s your specific challenge to the reimbursement?</strong></p>



<p><strong>Schiff</strong>: There isn&#8217;t a CPT code for a dispenser. It’s much more than a dispenser. We spoke with some of the payers early on in our process, and they expressed interest but wanted us to come back with hard data that shows our device achieves what we know it can. That is why we’ve been doing clinical studies. Columbia is now doing a phase II study and we’re working with two other major medical centers on other studies.</p>



<p><strong>Bashe: &nbsp;It sounds like your app provides the code like many security or multi-factor authentication systems. You’re emailed a code if you want to access PayPal on a new device. Sometimes they give you a one-time code for sending money as a security measure. It’s basic cyber security.</strong></p>



<p>You’re operating in an area where people can accidentally misuse or intentionally abuse a product. Your work gives us data on what is going on between the patient and access to the pill.</p>



<p><strong>Schiff:</strong> Yes, and I would add to that. We’re adapting our system to be able to dispense a drug called suboxone, which is widespread opioid addiction treatment. It comes in a film strip, and nobody could dispense it effectively before us.</p>



<p>For addiction patients, instead of asking them, for example, “What&#8217;s the pain level,” we can ask them, “What’s your craving level right now?”</p>



<p>If their craving levels are high the app can contact their doctor to alert them that the patient needs support.&nbsp; We&#8217;ve added a video recording component, as well. It’s optional, but because the only way that doctors can currently confirm that patients who take suboxone or methadone are adhering to their prescription and not diverting it, is that they are required to get a urine analysis once a week or every other week. We can have the patient take a video of every dose that shows they&#8217;re taking it each time they say they are so their provider can track it.</p>



<p>It reduces liability for the doctor and keeps patients on track, knowing they’re accountable. Up to 28% of suboxone prescriptions get diverted, and we can help keep those patients on track. It&#8217;s hard to break an addiction, and if we can help keep them on medication-assisted treatment, that&#8217;s highly valuable.</p>



<p><strong>Bashe: There is a saying that culture crushes innovation. What&#8217;s the culture around this topic, in your opinion?</strong></p>



<p><strong>Schiff</strong>: Glacial inertia. It’s a very slow process to change anything in this space. &nbsp;</p>



<p>For example, many people have endorsed using the device for methadone treatment. Patients on methadone must go to a clinic every day and stand in line, sometimes requiring a long trip. It’s time-consuming and stigmatizing. Our system can provide more comfort than take-home methadone is properly used, but current regulations stand in the way.</p>



<p>I’ve been trying to speak with politicians to get their take on it, but it&#8217;s not easy. One of the things that we’re exploring is tapping into this vast amount of money coming from the opioid settlements.</p>



<p>Many states and localities plan to use the money to pay for Naloxone. Naloxone is a great drug to reverse overdoses, but there&#8217;s only so much money to spend on Narcan. There&#8217;s money available in these settlements to try new methods to prevent and treat opioid addiction.</p>



<p><strong>Bashe:&nbsp; My last question deals with technology and the digital divide. As you said, this dispensing technology is based on an app with a smartphone that connects to the device. Is that correct?</strong></p>



<p><strong>Schiff</strong>: It is, and I know where you might be going with your questions. It&#8217;s available on any smartphone, Android or iPhone. We’ll also soon be developing a version of our system for text and phone so that you don’t need a smartphone.&nbsp; You text or call, put your information in, and it gives you back your code. The doctor can ask whatever questions they want to monitor your progress, just like with a smartphone. We want to make it as accessible as possible. We are also offering Spanish language in addition to English.</p>



<p><strong>Bashe: How about seniors?</strong></p>



<p><strong>Schiff</strong>: That&#8217;s where the phone option comes in. That would make it easier. I will caveat that our study did not involve seniors, and though that’s typical for a study like this, that’s data we should get.</p>



<p>One of the interesting pieces of feedback that we got is that with a child-proof bottle, you have to push and turn it, which can be difficult for an older patient or one with an upper extremity injury or weakness. Our system solves that issue, but you’re right: we have to study this more with older people, people with arthritis, and other disabilities. We’re trying to make it as straightforward as possible, but it will not be perfect immediately. Also, doctors don’t have to prescribe it to patients who can’t easily use it.</p>



<p><strong>Bashe: Yours is an exciting story of innovation. Historically we&#8217;ve looked at controlled drug monitoring systems that cast a suspicious eye on the patient. This system is not set up as, “Hey, I know you&#8217;re trying to scam the system, so I’ll make it super hard for you to get too drunk.”</strong></p>



<p><strong>This is “<em>How do I make it appropriate to understand when you&#8217;re taking the drug and when you no longer need it.”</em></strong></p>



<p><strong>Schiff</strong>: That’s what we&#8217;re trying to do. Not everybody feels that way when they see the device, but the feedback was very good from the research, and people appreciated that someone was looking out for them.</p>



<p>Along with medical devices, technology can play a major role in helping health professionals overcome some of the pain medication addiction challenges.&nbsp; However, the obstacles may not be engineering or generating sufficient clinical data from in-real world patient studies.&nbsp; Federal regulators and payers need to jump aboard as allies. The barriers facing Jay Schiff and other innovators are similar – obtaining reimbursement coding, securing conversations with health professional associations and finding provider partners to test new ideas.&nbsp; Along with innovation, collaboration may be among the essentials to success.</p>
<p>The post <a href="https://medika.life/policies-and-policing-didnt-stem-opioid-abuse-can-tech-be-a-solution/">Policies and Policing Didn&#8217;t Stem Opioid Abuse – Can Tech Be A Solution?</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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		<post-id xmlns="com-wordpress:feed-additions:1">16285</post-id>	</item>
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		<title>Four Ways COVID has Changed Health Tech</title>
		<link>https://medika.life/four-ways-covid-has-changed-health-tech/</link>
		
		<dc:creator><![CDATA[John Whyte MD]]></dc:creator>
		<pubDate>Thu, 30 Dec 2021 00:16:09 +0000</pubDate>
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		<guid isPermaLink="false">https://medika.life/?p=13549</guid>

					<description><![CDATA[<p>Like most tech lovers, I’m excited about the upcoming CES conference.&#160; I won’t be attending in person but will be watching it very closely from a virtual platform. As a physician, I am particularly interested in health tech and how it can improve patient outcomes – both individual patients as well as populations of patients. [&#8230;]</p>
<p>The post <a href="https://medika.life/four-ways-covid-has-changed-health-tech/">Four Ways COVID has Changed Health Tech</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
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<p>Like most tech lovers, I’m excited about the upcoming CES conference.&nbsp; I won’t be attending in person but will be watching it very closely from a virtual platform. As a physician, I am particularly interested in health tech and how it can improve patient outcomes – both individual patients as well as populations of patients. &nbsp;But my assessment of tech this year will be very different than previous years.&nbsp;</p>



<p>&nbsp;How so?</p>



<p>The COVID pandemic has changed the way we evaluate health technologies in four important and distinct ways.</p>



<ol class="wp-block-list" type="1"><li><strong>Practicality replaces glitz.</strong>&nbsp; The “Wow factor” is what mattered in the past.&nbsp; “Look how cool this laser is that can identify your heart rhythm from 300 feet away!” “This headset lets me see how food travels through my body in real time!”&nbsp; &nbsp;Technology can still be cool, but now the question is how will I use it?&nbsp; Wearables that measure important variables like blood pressure will get more attention than new imaging tools that simply provide a clearer picture.</li><li><strong>Prevention takes precedence over therapeutics.</strong>&nbsp; COVID has demonstrated to us the importance of our personal health.&nbsp; For too long, we made our jobs and other commitments our top priority.&nbsp; Going forward, one’s personal health will become a major focus, especially as it relates to prevention.&nbsp; How will a particular technology let me take control of my own health? &nbsp;Nowadays, I am now more interested in a toilet that can monitor my urine for signs of diabetes or my stool for colorectal cancer than a device that creates holograms.&nbsp; Once one gets pass the “icky” factor of some tools,&nbsp; we will evolve to truly personalized preventive medicine.</li><li><strong>Rigorous outcomes rule the day.</strong>&nbsp; Everything now will be measured by how did it change patient outcomes.&nbsp; Sure, it a device might show a new way to measure blood glucose – but what impact does it have on quality of life, co-morbidities, and life expectancy?</li><li><strong>Consumer centricity rather than physician centricity.</strong>&nbsp; In the past, technology has been focused on the health system and doctors.&nbsp; It’s been a B-B approach.&nbsp; That won’t go away, but more and more tech innovations will put the health consumer in charge.&nbsp; For instance, I won’t be wearing a device that sends all the information to my doctor, but rather there will be more interpretation of all the data from wearables with direct communication to the patient.&nbsp; This may require changes in regulation by the US Food and Drug Administration with a more practical definition of what constitutes a “medical device.”&nbsp;</li></ol>



<p>The real future of &nbsp;digital health is when tech tools&nbsp; continuously collect health data points and help interpret the information and provide preliminary diagnoses to patients.&nbsp;&nbsp; The doctor isn’t going to be left out of this equation, but the difference will be that the patient will no longer be left out.&nbsp; It’s the patient who will be at the center of how these technologies function from start to finish.</p>



<p>I’m sure I still going to be wow-ed this year and be entertained by the advancements we have made, especially during the last two years. But I’m also going to ask tougher questions on innovation, especially as relates to the purpose and impact.</p>
<p>The post <a href="https://medika.life/four-ways-covid-has-changed-health-tech/">Four Ways COVID has Changed Health Tech</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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