Five Reasons why the FDA got it Right with Digital Health


The FDA recently announced its Digital Health Innovation Action Plan.  This plan was both important and necessary.  Digital health differs significantly from drugs and traditional medical devices around which the FDA has developed its structure and policies over decades. Digital health software technologies have far less involvement by clinicians in product development than Pharma or medical device companies.  Innovation and improvements in digital health occur at lightning speed in comparison to other FDA regulated industries and require different approval and oversight strategies (see below).  Multifunctional digital health technology interacting with both drugs and devices creates a need for a new agency framework and workflow for such combined products. The Action Plan is a major step in the right direction because it recognizes digital health’s unique attributes which span both IT and clinical arenas. In addition it recognizes the need for infrastructural and process changes in the agency itself. It will address lingering issues such as multifunctional software (technology which has software qualifying as a medical device combined with that which doesn’t).

  1. The Action Plan builds on and improves previous digital health guidances. The FDA has previously released guidance documents on Mobile Medical Apps and General Principles of Software Validation. These were a well thought out and developed group of guidelines with patient safety as a focus. The Action plan includes a plan to issue a new draft guidance by the end of 2017 on mobile medical apps, medical device data systems (used for the electronic transfer, storage, display, or conversion of medical device data), medical image storage devices, medical image communications devices, low-risk general wellness products, and laboratory workflow.  This guidance will reflect  the impact of The 21st Century Cures Act passed by Congress last year on previous FDA guidelines on software. The FDASIA Health IT Report from the Office of the National Coordinator left many unanswered questions about clinical decision support technologies. The Action Plan is in part designed to address that gap by planning a Guidance on Clinical Decision Support by Q1 of 2018.
  2. The FDA will have new digital health experts.  The Innovation plan reflects the need for hiring digital health technology experts by the agency.  According to the Action Plan, the FDA’s goal is is to build a cadre of experts with a deep understanding and experience with software development and its application to medical devices. This new staff will work with reviewers, compliance officers, and others within the FDA to improve the quality, predictability, consistency, timeliness, and efficiency of decision-making on individual products and firms.”  In addition, the agency is to launch an Entrepreneurs in Residence program for “…thought leaders and others with real experience in software development to build and structure the digital health function within CDRH [FDA’s Center for Devices and Radiologic Health] as it – and the market – grows.”  This input from industry leaders will provide the leadership in designing the FDA’s structure and approach in order for it to get digital health addressed in the manner it deserves.
  3. A Pre-cert program will be about the developer not the software. A simplistic explanation of this program would describe it as analogous to the TSA’s Precheck Program. According to the Action Plan, this Software Certification Pilot Program  … could “pre-certify” eligible digital health developers who demonstrate a culture of quality and organizational excellence based on objective criteria, for example, that they can and do excel in software design, development, and validation (testing). Pre-certified developers could then qualify to be able to market their lower-risk devices without additional FDA review or with a more streamlined premarket review.”   This program would both set quality development standards and streamline approval processes. This pre-cert pilot program is admirably designed  “…to leverage customer input to develop a program that can help reduce the time and cost of market entry for software developers that FDA determines reliably manufacture high-quality, safe and effective digital health devices while providing appropriate patient safeguards.”
  4. The FDA will work with other global agencies. Last year the International Medical Device Regulators Forum (IMDRF) published a proposal for the clinical evaluation of software as a medical device.  The FDA issued this as a draft guidance and it is expected to adopt the final IMDRF version as a final guidance. This global initiative will allow for faster, less expensive and standardized adoption and oversight of this type of technology.
  5. The upgrade approval process will be clarified. The Action Plan calls for a final version guidance by the end of 2017 of its draft proposal of Deciding When to Submit a 510(k) Software Change to an Existing Device. The Plan states that this final guidance “includes guiding principles as well as a simple to follow flow chart, with the aim of setting clear, practical, and transparent regulatory expectations.”

This Action Plan seeks to improve on previous FDA guidances and initiatives.  It recognizes the need for infrastructural changes of the FDA itself to support digital health, and necessary input from industry leaders.  Bakul Patel and the FDA should be commended for developing this Action Plan in response to industry leaders looking for detailed support for improving, crystallizing, standardizing, and streamlining oversight policies. I look forward to downstream developments arising from it and encourage those developers clamoring for a voice at the table to apply for the Pre-Cert Pilot Program.

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Five Digital Health Imperatives for Patient Safety


The most discussed issues in healthcare today are cost savings and access to care.  There is no denying their rightful preeminence in the public discourse.  Something which has received more attention in the past but has been surpassed by the aforementioned topics in both lay and healthcare policy press has been patient safety. Perhaps the best definition of patient safety is that of the World Health Organization. Simply put, it is “…the prevention of errors and adverse effects to patients associated with health care.” Patient safety initiatives have taken many forms. Most are aware of public awareness (ex. healthcare worker hand washing) and regulatory clinical requirements (ex. wrong site/procedure/ person surgeries) publicized in the past. Digital tools now present opportunities for unprecedented improvements in patient safety. I would like to highlight a few.

  1. Improving health literacy. Health literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health  What does health literacy have to do with patient safety? People who do not know their diagnoses when they leave an office visit or hospital (some estimates are 60%) or do not know the reasons for each medication they are prescribed are much more likely to be non-adherent to medical advice or recommended treatment regimens. In fact, low health literacy is related to higher mortality rates. In a post I wrote here in 2012, I discussed some of the implications of low health literacy. In one study last year examining the extent of use of digital health tools in relation to health literacy, it was found that those subjects with low health literacy used these tools less. Though there is much to be desired regarding the analysis in this study, the authors are to be commended for the number of participants (>5000) and for highlighting how health literacy and digital technology can affect each other.  According to the Department of Health and Human Services, only 12 percent of US adults are health literate. Improving health literacy via digital tools is not only an opportunity it is necessary. The 15 or 20 minute office visit does not afford even the best physician to explain a diagnosis or proposed treatment plan in a digestible way a patient and caregiver deserve. Language barriers compound the health literacy dilemma. There is a well-established legal framework for language access. The cost to providers and inaccessibility outside of the clinic or hospital make mainstream language translation technology insufficient to close gaps in care.  Mobile non-human digital language translation tools will hopefully soon become the preferred alternative.
  2. The use of AI in workflow. There’s been a lot of buzz about artificial intelligence (AI). The present popular conversations surrounding AI involve speculation whether AI will replace humans in every possible aspect of healthcare. There are even statistics bantered about as to percentage of physicians, nurses, and others who will lose their jobs to AI technology.  That aside, AI can have a significant role in improving patient safety.  Medtronic, Masimo, and others are working with the Patient Safety Movement Foundation by sharing de-identified data from medical devices in designing predictive analytics programs with the ultimate goal of improving patient safety. Many software platforms exist which claim they improve patient safety but evidence is scarce.  In advertizing their software, many companies equate hospital readmissions with a patient safety metric though strictly speaking it isn’t by the definition above unless it is related to a complication of treatment rendered during the prior hospitalization. Predictive analytics and other AI may however be relevant to patient safety by gathering data from the patient’s EHR (and heaven help us one day from data sets of other systems) to predict both minor and major preventable adverse events. AI platforms have the opportunity to make all the data about a patient come to life, integrate and provide a real-time picture of what is happening to the patient and provide alerts which might change treatment. AI is technology which needs to be incorporated into workflows which themselves are designed with maximum patient safety in mind. In this manner, the human aspect in patient safety is still important.
  3. The use of digital tools for inventory and other tracking. Inventory tracking in both the enterprise and ambulatory clinic is an important patient safety issue.  Equipment servicing schedules, drug, medical device, patient and personnel tracking and other logistical considerations are important in patient safety. RFID and other advanced digital technologies have been developed to help in this regard.
  4. Improving the electronic medical record (EHR). A 2016 study published in the Journal of Patient Safety demonstrated a 17-30% reduction of in-hospital adverse events in patients with cardiovascular diagnoses, pneumonia or a diagnosis leading to surgery when a fully electronic EHR is used. Specifically the adverse events included hospital-acquired infections, adverse drug events (based on selected medications), and post-procedural events. As this studied playing field has leveled today with the vast majority of institutions utilizing completely electronic records, there exist yet more opportunities for improving patient safety with EHR associated technologies. One hot button issue is that of matching of patients with their own EHR record. The challenge lies in the strong legislative opposition to a unique national patient identifier.  To this end the Office of the National Coordinator has launched a Patient Matching Algorithm Challenge.  Other ways in which the EHR can improve patient safety involve the use of AI (see above). Input from patients in reviewing their records via the patient portal is arguably the first place to start.
  5. IT security. IT security is a direct and indirect threat to patient safety. This has been demonstrated with cardiac implantable electronic devices and recent global IT hacking which involved hospital systems. A technology called blockchain was developed in 2008 and has found its biggest interest in the financial industry. The use of blockchain in healthcare has been discussed for a number of years.  However there exist significant challenges in the utilization of blockchain for patient records.

While popular discussions focus on health insurance coverage, shortcomings of EHRs and the health system in general, we must never lose sight of what should be the focus of care itself, patients.  Healthcare must be accessible, affordable, efficient, of high quality with good outcomes and most of all as safe as possible. Patient safety should always be a metric of good care and new programs and technologies.

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The The Five Biggest Areas of Opportunity for Digital Health


Digital health is unquestionably becoming part of healthcare lexicon and fabric. Electronic health records (EHRs) and personal fitness trackers have helped create awareness through use.  The entrepreneurial enthusiasm for the healthcare space is evident by the volume of digital health incubators, medical school innovation centers,  and angel investors.  Though there has been significant sector investment, the road to success of adoption in the healthcare enterprise has been challenging.  I’d like to discuss what I believe are five areas of significant opportunity for quality technologies.

  1. EHRs. According to most recent statistics from the Office of the National Coordinator, use of EHRs has increased from 20% in 2004 to 87% in 2015. EHRs were designed as documentation centers for billing and regulatory purposes. Relevant clinical patient management data workflow was not a priority and remains a major pain point for clinicians today. According to a study in the American Journal of Emergency Medicine ER physicians spend only 28% of their time in direct face to face patient contact and can go through 4000 computer mouse clicks in one shift.  From a provider standpoint. the regulatory and billing data entry should be performed by someone else and relegated to an (almost) invisible part of the EHR.  We need EHRs which are clinically oriented with good user interfaces. Interoperability [defined by the federal Office of the National Coordinator for health information technology (HIT) as the ability of information systems to exchange patients’ electronic health information and use information from other EHR systems without any special effort from the user] is another major pain point that needs to be addressed. .Six years into Meaningful Use we have yet to achieve any significant interoperability of EHRs. There are hospitals within the same healthcare system in many places with disparate EHRs which do not talk to each other or exchange information.  Increasing healthcare consolidation of hospitals has exacerbated the problem of lack of interoperability. Health Information Exchanges (HIEs) have been woefully underfunded and have fallen short of their vision. There remain many opportunities for technologies to assist in achieving true interoperability.
  2. Clinical trials. CIOs are constantly inundated with requests to purchase new technologies which will “save money, improve patient satisfaction and outcomes and decrease readmissions.” What is in fact lacking in most cases is evidence for these claims.  The hesitation of many entrepreneurs to embrace the intuitive adoption requirement of proof of claim (which needs to be said should not differ from the adoption of product in any field of endeavor making claims) is the misconception that time-consuming large costly randomized clinical trials are what I am referring to. This should not however translate to “take my word for it” is all you need. I agree that traditional trials are neither practical nor necessary for most tools. Even the FDA has now recognized with thoughtful and cautious restraint a role for ‘real world evidence’ (defined by the legislation as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials,” including sources such as “ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research activities.” in the approval process of drugs. Thus, the opportunity for trials utilizing digital registries, mobile clinical trial platforms, quality communications and analytics tools is significant.
  3. Artificial Intelligence (AI). One early definition of Artificial Intelligence (AI) in medicine (1984) was “…the construction of AI programs that perform diagnosis and make therapy recommendations. Unlike medical applications based on other programming methods, such as purely statistical and probabilistic methods, medical AI programs are based on symbolic models of disease entities and their relationship to patient factors and clinical manifestations.” Today a broader definition may be applied: “the simulation of human intelligence processes by machines, especially computer systems. These processes include learning (the acquisition of information and rules for using the information), reasoning (using the rules to reach approximate or definite conclusions), and self-correction.” The use of artificial intelligence in medicine has been the subject of intense and rapidly growing interest in medical, computer science, and business arenas.  The market growth of AI is based on its projected impact on both technology and non-technology sectors. There have been arguments for and against the inevitability of replacement of physicians by AI technologies for a while now. The debate continues. BASF declared “We don’t make the household product, we make the product better.” An analogy can surely be made with AI. It runs in the background of technologies already in use but will make them run faster and more importantly will add a dimension of relevance of incoming data.
  4. Personalized medicine. The National Cancer Institute’s definition of personalized medicine is “a form of medicine that uses information about a person’s genes, proteins, and environment to prevent, diagnose, and treat disease…” Personalized medicine is medical care directed in whole or part from information specific to an individual.  Discoveries in the area of the genetics of cancer have resulted in the development of drugs no longer targeted towards an anatomical location but a specific genetic marker. A landmark clinical trial in which drugs are given solely on the basis of genetic markers identified in the cancer tissue itself is the NCI-MATCH Trial (Molecular Analysis for Therapy Choice). “Patients with advanced solid tumors, lymphomas, or myeloma may be eligible for MATCH, once they have progressed on standard treatment for their cancer or if they have a rare cancer for which there is no standard treatment.” The role of personally derived connected data (from sensors external or internal to the body) will also facilitate personalized medical care. Opportunities thus exist for life sciences and technology companies to develop products for this new therapeutic approach.
  5. Social Media. An early observational study of synergistic impacts of healthcare and social media demonstrated that personal experiences and not data drive social media healthcare discussions. One early survey of physicians on their use of social media found that “85% of oncologists and primary care physicians use social media at least once a week or once a day to scan or explore health information. Sixty percent said social media improves the care they deliver.” The potential for social media to disseminate information from published clinical trials, the exchange of professional education among peers, and discussions surrounding disease states is invaluable.  To be sure there exist professional and regulatory guidelines for the use of social media for providers, vendors and other healthcare stakeholders.  Social media open platforms in healthcare have proven successful for patients, caregivers and others.  Examples areTreatment Diaries, patientslikeme, and WEGOHEALTH.  Potential opportunities here involve recruitment of patients for clinical trials, gleaning real world evidence data from discussions.

By no means is this a complete discussion of opportunities for digital health. These are what I consider the ‘biggest bang for the buck’ ones doable today. I look forward to comments and the sharing of experiences from others. As a consultant I am amazed on a daily basis at the high quality clinical, financial and personal experience energies devoted to the development and advocacy for digital health tools. Bring it!

 

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Healthcare Consolidation: Opportunities for Digital Health Technology


Healthcare consolidation in the form of mergers and acquisitions has been taking place for a number of years.  It is seen on both the provider and payer sides.  In his testimony on healthcare market’s consolidation effects on quality, cost and access, Paul Ginsberg, Director of Public Policy at the USC Schaeffer Center for Health Policy and Economics cites some key drivers of consolidation. ACOs require scaling which small hospitals cannot provide.  Younger physicians prefer associations with larger enterprises.  The costs for EHR and other technology acquisition and maintenance are too costly for smaller hospitals, and pressures of decreased payment rates are increasing on the provider side.  Payers are consolidating as well because of pressures to scale for clients across large geographical regions and to support costs of technology.  I would add that the enactment (and some would say the design) of the ACA itself spurred payer consolidation. It is interesting to note that a 2012 report by the Robert Wood Johnson Foundation on this topic concluded that hospital consolidation increases healthcare costs and that physician-hospital consolidation has neither improved quality of care or reduced costs. Healthcare consolidation on the other hand, might lead to internal cost savings with increased available resources to invest in technology.  Certainly this remains to be seen.  Consolidation includes both human and material resource consolidation.  I will focus on areas where I believe technology can facilitate consolidation by addressing pain points.

Electronic health records purchase, maintenance, and associated technologies (analytics, digital imaging, patient monitoring, etc) are now necessary big-ticket items in healthcare. Unfortunately the timing of consolidation sometimes doesn’t coincide with optimal purchase evaluation and merging of technologies by the involved parties. This often results in the maintenance of multiple EHR vendors for inpatient systems and even more if one includes outpatient setting.  There are large institutions in the USA who are decades past merging and still have disparate EHR systems which do not communicate with each other. Consolidation often results in providers needing to go to new hospitals or offices, necessitating training on new EHR systems. In addition, the current use of electronic portals by patients to view their medical record is abysmal. A survey by athenahealth  reveals that although 87% of patients want electronic access to their medical records only 29% actually use portals. Both providers and patients usually have to negotiate diverse healthcare site-specific platforms. One potential solution lies in the adoption of a user-friendly universal EHR interface which provides a simple and standardized user experience on both provider and patient (portal) ends regardless of the EHR technology used.

Consolidation offers the opportunity for hospitals to reevaluate purchasing a new EHR system (as many already have or are considering).  Healthcare IT can play a major role in M & A for providers.  There are many considerations when EHRs collide.

Other non-clinical considerations.  Some of the non-clinical areas include standardizing logistics and tracking.  This relates to tracking of medications which can improve patient safety, tracking of patients which can increase effective bed capacity from 5-20%, and  tracking of supply chain assets which connects inventory data with clinical/procedural data to streamline billing and avoid unexpected equipment shortages. Technologies which lend themselves to this include traditional bar coding, RFID (radio-frequency identification), and potentially blockchain, an advanced information technology well-established in the finance sector but presently only talked about in healthcare.

Clinical applications.  Consolidation often brings together different institutional cultures.  This may be reflected in how physicians, nurses and other clinical personnel are trained, compensated, and included in policy and procedural changes. Its extent includes but is not limited to clinical organizational structure, clinical policies, hospital drug/device formularies, referral networks, clinical research, medical education, and reassignment of workplaces. Patients are affected directly and indirectly. The immediate reaction of patients and caregivers is commonly apprehension. The patient’s clinical experience will be a significant priority in planning the logistics and final outcome of a consolidation plan.  Marketers of the new entity will refocus on patient satisfaction.  Brand loyalty might be a challenge in the case of purchasing or merging with a competitor. This presents opportunities for creating patient “stickiness.”  The adoption of patient and caregiver-facing tools (which may include appointment apps, remote patient monitoring for self-management of chronic diseases, a standardized enhanced patient portal/communications platform, digital patient education tools, telehealth video conferencing, and others) can generate a message of patients as a priority.  Instituting new system-wide clinician-facing tools including consolidated mobile digital imaging tools, communication tools, mobile inpatient telemetry apps, clinician scheduling/logistics/ communication tools,  operating room video/patient monitoring, mobile clinical trial platforms, and best of breed medical and continuing education tools are ways to attract and retain top clinical talent.

Value based payment models.  Consolidation in the era of value-based payment models presents opportunities for improvement of care. In fact arguments for consolidation are based on the promise of improved cheaper care. This has yet to be demonstrated (in healthcare or any other industry). This type of payment system shifts the ROI of digital technology from one based on revenue generation to cost savings.  The significance of such a shift cannot be overstated because it ideally aligns cost with the presumed overriding objective of better patient outcomes. Remote patient monitoring,   predictive analytics, and mobile technologies are being utilized by both providers directly and indirectly health management companies contracted by payers. The power of these tools resides in the data and analytics they hopefully deliver to providers, patients and caregivers in a filtered, actionable and easily digestible fashion.

In summary, consolidation in healthcare affords opportunities for technology to address pain points which are organizational, clinical, and image management in nature.  The goal should not be for the imposition of the dominant partner of its operations but to seize the occasion to reshape the new entity to something even better via cohesive innovation.

 

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Five VALUE Offerings of the Ideal Health Management Company


     In previous posts I discussed the importance of population health management and the essentials of ideal population management digital tech.  One of my tenets as a consultant in digital health is that technology itself is not a solution.  A technology is a tool which only becomes a solution when it is placed in a context of healthcare needs, provider, patient and caregiver workflows, and incorporates human interactions which close the loop on significant outlying data. Though there are many similarities in technologies (connected care devices, data collected) among companies, the human component and workflows can vary significantly.  This is where the rubber meets the road regarding outcomes. There are now many companies in the health management space with both verified and unsubstantiated claims. I will discuss five areas which I believe are going to make a difference in patient reported outcomes.

  1. Virtual visits. It is clear from industry trends that virtual visits are rapidly becoming part of the healthcare landscape. In fact more than half of all patient interactions at Kaiser Permanente are virtual ones via smartphone, kiosk, or computer. Virtual visits are now part of medicine worldwide.  A healthcare management company must have virtual visits as a key component because it meets the mission of transforming the point of living into point of care.
  2. Aging at home. It is not a secret that people wish not to be institutionalized in their ‘golden years.’ The potential benefits of digital tech in the home of the aging have implications for societal cost savings and improved patient reported outcomes. Just as important is keeping patients with chronic diseases stable enough to avoid being hospitalized and receiving non-critical care at home.  In addition, the overall benefits to society of home care should not be minimized.  Healthcare management companies can best be utilized to prevent hospitalizations by encouraging and supporting self-management of chronic diseases as well as providing services which support medical care at home.
  3. Literacy improvement. The issue of health literacy is not a new one.  However, given increasingly complex care patients need (see healthcare navigation below), expanding cultural diversity and aging populations, decreased face to face encounter time, and the epidemic of chronic diseases, the lack of health literacy has become a major barrier to better patient outcomes. Health management companies must have health literacy as a major focus, without which other initiatives are sure to fail. Literacy must e considered in human coaching interactions (explaining the diagnosis, rationale of care, and instructions for medication/device use), the type of technologies offered to patients, and in patient and caregiver educational materials provided.
  4. Unmet needs (navigation, rare diseases). A primary concern of many patients and caregivers today is not necessarily the quality of the healthcare provider or even getting the medicines they need but where to go to or call and when.  This is known as healthcare navigation which can literally be pivotal in determining life and death of people. This is no more vividly experienced than in the case of a cancer patient and more so with a patient with a rare disease, cancer or otherwise. Home health management companies can assist with patient and caregiver navigation by providing emotional support and educational and care coordination resources.
  5. Empathy.  The Oxford Dictionary’s definition of empathy is “The ability to understand and share the feelings of another.” A more in depth and interesting discussion on empathy is offered by the Center for Building a Culture of Empathy.  Dr. Jodi Halpern in an article in the Journal of General Internal Medicine describes the concept of clinical empathy. According to Halpern, barriers to clinicians’ empathy towards patients include anxiety arising from time constraints, the inability for the physician to recognize the importance of patients’ emotional needs in the context of care, and preexisting tension between the doctor and patient. However, it has been demonstrated that physicians can learn empathy.  Empathy must be part of a healthcare management company’s mission statement. Having this mindset run in both the forefront and background of operations reminds all concerned that we are dealing with people not the disease they have.

A healthcare management company in essence is acting in a patient advocacy role. The success of such companies is testimony to gaps in care that exist in the system.  As we experience a growth in the deployment of digital technologies for population health management, aging at home, wellness, and preventive medicine, we must always be cognizant of the importance of human interaction.  The best healthcare management companies will always be those who have the most dedicated, trained, and empathetic people.

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Five Ways Digital Technologies can Address Cancer


There have been remarkable strides in prevention and treatment of disease in the past 5 decades.  Few have rivaled targeted cancer therapies based on digital health, specifically genomics in scope and breadth.  I’d like to touch on a few ways in which digital technology is impacting cancer.

1. Targeted therapies. One only has to watch the avalanche of television commercials for cancer centers both local and national to appreciate the role genomics now plays in choosing therapies today for cancer. In simple terms, cancers have genetic fingerprints which are becoming specific targets of newer drugs. Different types of cancers may share similar genetic markers. Getting more layered in complexity, the same cancer may experience genetic changes during its course.  The National Cancer Institute offers a more in depth discussion of genomics and cancer.  An ambitious initiative with far-reaching implications is the National Cancer Institute’s NCI-MATCH (Molecular Analysis for Therapy Choice) trial. IBM Watson Health has recently partnered with Quest Diagnostics to provide clinicians with recommended “… unbiased, evidence-based approaches based on a detailed view of the tumor’s mutations, scientific journals, and MSK’s OncoKB, a precision oncology knowledge base..” The possibilities are indeed many in this space and the use of digital tools like genomics and artificial intelligence are accelerating our knowledge and successes.

2. Registries.The traditional collection of information on cancer has been with the collection of limited data derived from patient demographics, health history and episodic office encounters. There are now digital technologies now which incorporate raw data from pathology, genomics, imaging studies, patient reported symptoms and follow-up and more. In a previous post I describe ways in which a well-designed registry can address multiple stakeholder needs. The value of an excellent tech-based registry is best appreciated in oncology and rare diseases. As someone who has a family member with a very rare cancer, I have seen first-hand the potential benefits of and resistance (primarily ‘political’) to such registries which would expedite decision-making via pooled experiences.

3. Connected care: apps: Connected care today includes such technologies as wearables and mobile health apps. Benefits of connected care include triangulating the transmission of information (among clinicians, patients and caregivers), convenience, and timeliness. Three impressive mobile apps in the oncology space are:

a. Pocket Cancer Care Guide. Helps patients and caregiver obtain information about specific cancers, understand medical terminology, builds lists of questions to ask physicians, and provides the ability to record and save clinicians’ answers to questions.

b. Cancer Side-Effects Helper by pearlpoint. “…offers trusted nutrition guidance and practical tips to help survivors feel better, maintain strength, and speed recovery from common cancer side effects…”

c. My Cancer Genome. Managed by the Vanderbilt-Ingram Cancer Center, this award-winning app has both clinician and patient-facing information on cancer genomes, targeted therapies, and provides updated appropriate available clinical trials.

4. Connected clinical trials. The rising cost of clinical trials, the increasingly recognized importance of patient reported outcomes, and the transformation of trials with electronic data capture all suggest the value proposition of digital tech in clinical trials. Obtaining real-time vital sign trends, patient-reported adverse events (drug side effects/toxicities, unplanned ER or office visits), and outcomes data will make clinical trials more relevant (by recruiting a larger and more diverse patient population via digital tools), less costly and safer.

5. Social media support. The convergence of social media and healthcare was both inevitable and beneficial for patients. The advantages of online support groups over traditional in real life organizations are many. Access to information, governmental agencies, empathy, and convenience are some of them. Twitter has contributed greatly in this regard. TweetChat groups focusing  on specific diseases abound.

Critics of digital technology in healthcare raise valid issues regarding accuracy and reliability of information, privacy and security, and patient safety. There are existing regulatory guidelines addressing these, arguably not comprehensively enough.  Accurate and reliable information about cancer is available via many digital avenues. Digital technologies are an integral part of cancer diagnosis and treatment today.  We are living in an age where they might be among the most important tools we have as clinicians, patients, and caregivers. Hats off to those dreamers who make it possible!

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Digital Health Technologies for Alzheimer’s Disease


The statistics related to Alzheimer’s disease (Ad) are astonishing. According to The Alzheimer’s Association there are over 5 million Americans with Ad. It is the sixth leading cause of death. More than 15 million caregivers provided an estimated 18.1 billion hours of unpaid care at a value of approximately $221.3B. The impact of this disease is also well-illustrated in a recent  PBS documentary.  While it might seem incongruous on the surface to discuss digital technology and a population with significant cognitive challenges, I will illustrate how it can be beneficial at different stages of the disease’s course.

Cognitive Assessment Tools.  Most tools for assessing cognitive abilities have been of the traditional written form, as offered by the Alzheimer’s Association.  The ability of digital tools to detect early diagnosis of Ad is important in medical and social planning for the patient and family. Some have taken traditional diagnostic tools and transformed them into a digital platform. Such is the case with Quest Diagnostics’ CogniSense.  A more transformational approach is one seen with utilization of the Anoto Pen which can measure the writing instrument’s position up to 80 times per second. An exciting study by the Lahey Medical Center and MIT’s Computational Science and Artificial Intelligence Laboratory looked at using the Anoto Pen versus traditional cognitive assessment tools for Ad and other diseases. This method has already shown advantages over traditional tools, described in an MIT News piece: “… while healthy adults spend more time on the dCDT [digital clock drawing test via Anoto] thinking (with the pen off the paper) than “inking,” memory-impaired subjects spend even more time than that thinking rather than inking. Parkinson’s subjects, meanwhile, took longer to draw clocks that tended to be smaller, suggesting that they are working harder, but producing less — an insight not detectable with previous analysis systems…”  A digital platform called Neurotrack claims it has the ability to detect Ad at its earliest stages by assessing recognition memory, a function specific to the brain’s hippocampal region which is affected early in the course of Ad. Digital assessment tools like these can also save clinician time and offer a better objective patient assessment.

Cognitive Improvement tools. A handful of small studies have shown that ‘brain exercise’ in the form of cognitive augmentation games decreases the risk in normal individuals of getting Ad. One would naturally ask if this carries over to those already diagnosed AD. Some earlier studies suggested this was the case. An older review of multiple small studies showed that while they suggest that brain exercises slowed progression of cognitive decay they did not affect mood or the ability to care for oneself.  It is worthy of noting that patients with larger baseline ‘cognitive reserve’ do better to a point then characteristically have a rapidly progressive course. In a previous post I discussed the merits of music as an ideal digital health tool. Music should be considered as a potentially much appreciated and useful tool.  Relative to Ad specifically, I would reference the incredibly informative and moving award-winning film Alive Inside, documenting the response of patients with severe Ad to music relevant to their personal past. An intriguing interactive game/tool is Tovertafel, a Dutch technology which projects via suspended box visuals onto a table.  There are various exercises and games on the platform which are both enjoyable and mentally stimulating. Less sophisticated yet popular games are offered by the Alzheimer’s Association.

Tools for monitoring daily activities. Technologies have been developed to aid patients with mild to moderate disease and their caregivers to make daily activities easier and safer. SmartSole makes an innersole with a GPS locator with an associated smartphone app and call service for alerts. Silver Mother by Sen.se is a customizable digital tech platform (front door position, room temperature, and water and food containers) connecting caregivers with love ones’ activities of daily living.  For patients with early dementia or for caretakers to connect with loved ones at a distance, grandCARE is a very comprehensive platform and service.

While one might associate digital tools with those of us who are “connected,” their utility in the realm of Ad can be profound.  I would submit that the potential for digital tech to prolong independence and/or improve lives of caregivers in the home or at a distance must be the subject of clinical studies.  Public health policy might very well change as a result of such outcome studies.

As a disclaimer I am not associated with any technology or organization mentioned in this post.

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Opioid Drug Addiction: How Digital Health Technologies Can Help


After a hiatus I am returning to my beloved Digital Health Corner.  I appreciate all my loyal followers and have attempted to bridge my absence with posts in other social media.

In a previous post I discussed important public health issues that digital technology can address. Among them is drug addiction. We are all aware of the opioid epidemic and the human destruction in its wake.  However statistics have an impact that reaches beyond qualitative descriptions.  According to the National Institute on Drug Abuse (NIDA) from 2001 to 2014, deaths due to overdoses in the USA were noted as:

  • 8 fold increase due to prescription drugs
  • 4 fold increase due to prescription opioids
  • 6 fold increase due to heroin
  • 5 fold increase due to benzodiazepines
  • 42% increase due to cocaine

Tragic personal narratives provide a human fabric to the now commonplace trumpeting of generic news stories about the extent of the drug problem.  An important keystone for any healthcare strategy for chronic disease is patient self-management.  Giving patients tools to support them in their journey of recovery is imperative.  Digital technology use in the addiction space is not a new concept. The use of computer-based programs for addiction prevention and treatment was described as far back as ten years ago. The creation of virtual resources for information, guidance and support is necessary to addicts who are, for the most part digitally connected. I will touch on some potential applications of digital technologies to all relevant stakeholders.

The NIDA of the NIH  has a group of evidence-based screening tools for adolescents and adults to be used by health professionals. Notwithstanding this, many healthcare providers fail to utilize evidence-based treatments because they are not trained to do so. Technology can become a vehicle used to bridge this knowledge gap while also addressing logistical and economic challenges in drug treatment. Digital resources for families and caregivers are necessary as well.

There are various types of tech-assisted treatments. One is known as the Technology Educational System which is a multimedia approach focused on behavioral training. Another such program is the CBT4CBT (Computer-Based Training for Cognitive Behavioral Therapy).  Studies of TES and CBT4CBT on outcomes and other endpoints are favorable. A nice summary of the studies by the NIDA discusses the impressive positive effects on abstinence.

The classification of substance abuse as a chronic condition by the ACA has implications with regards to digital health. It has spawned interest in telehealth as a treatment tool. There are medication assisted treatment (MATx) mobile apps to guide physicians in utilizing pharmaceutical drugs to treat addiction. It includes prescribing guides, clinical support information, and contact resources.

Drug addiction affects all age groups. Digital technology, especially mobile technology is not something to be used in a vacuum in this clinical setting. There are significant physical and mental health issues associated with opioid substance abuse which require human intervention, at times on a frequent outpatient or inpatient basis. However, as supportive mechanisms for providers, patients, and caregivers, it can facilitate better care, communication, and education. As in other areas of healthcare, the question as to which publicly available mobile apps are safe, useful, and supported by healthcare professionals is always present. This is, as readers of this blog know well, a topic for other discussions. The toll of opioid addiction on Society, the prohibitive cost of rehab, and shortage of mental health personnel and addiction specialists mandates a call to arms for quality accessible and effective mobile tools. I look forward to all the brilliant minds in digital health and those whose lives have been affected by addiction to step forward and not wait for a government ‘fix’ to this problem.

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Five Public Health Needs for Digital Health Technology


 

Digital health technology has seen an incredible growth in the last few years, fueled by a combination of consumerization of wearable technologies,  ubiquity of mobile devices, proliferation of technology incubators, attention by government health and regulatory agencies and involvement of large companies heretofore not focused on healthcare. The fastest path to widespread adoption of these technologies is the application to the most pressing public health needs.  The mission of public health is to improve the public health and achieve equity in health status. A review of studies of text messaging for health demonstrates a general positive effect on health-related behavior. These findings, as well as growing demand for more economical, convenient, and outcome-oriented data-focused care are driving interest in digital health tools.

A recent report on public health state by state by the Trust for America’s Health describes the dilemma of increased general healthcare spending and increased public health needs with their associated decreased funding allocations. I would like to highlight what I see as public health issues ripe for digital health technologies, some of which have already spurred initiatives.

  1. Mental Health. The disappointingly slow recognition of mental illness as a medical problem is compounded by the paucity of human and digital educational, and monitoring resources in the field. While there are currently some technologies focused on mental health, their scope lies more in the consumer than medical realm.  An interesting recent review of mental health mobile apps in the journal Nature discusses positive feasibility studies but a lack of robust outcomes data. In addition, some unintended consequences of at least one app were found.  Tools providing support for medication adherence, urgent virtual visits with clinicians and self-management will have maximal effects in this sector.
  2. Opioid addiction. The National Institute on Drug Abuse has long recognized the potential of mobile health technologies for its mission. The Agency for Healthcare Research and Quality is launching a three-year $19M initiative focusing on mobile apps and telehealth aids for rural physicians in efforts to treat opioid addiction.  The Substance Abuse and Mental Health Services Administration recently released a free mobile app for clinicians called MATx.  It provides information and guidance to medication assisted treatment of opioid addiction. An interesting company to watch in the sector is Pear Therapeutics which offers a patient-facing mobile app combining digital tools to be used in association with medication-associated treatment for opioid dependence (other tools in their portfolio address other disorders such as PTSD and schizophrenia).
  3. Childhood nutrition. Nutrition is an important aspect of a child’s health regardless of age.  CDC statistics on childhood obesity are sobering.  Supporting education about the problem are reports such as the WHO Guidelines for Sugars Intake and the Global Nutrition Targets which includes its Childhood Overweight Policy Brief.  Digital health technology is going to be critical to providing educational and self-management tools to young people and their parents. Digital natives are experiencing the obesity epidemic and expect digital resources to help them. One company in the forefront of this effort is My Shapers which targets children ages 6-11 years old.
  4. Adult physical inactivity. Physical inactivity is a known significant risk factor for cardiovascular diseases. I have discussed threads between consumer and traditional healthcare digital strategies in previous pieces. Front and center in these discussions are wearable sensor devices intended to promote physical activity.  Though use of activity trackers has failed in one study to result in weight loss they resulted in improved fitness, body composition, diet, and increased physical activity.  They are used by millions of people to at least remind them to be more active which itself might promote better health. Trackers are being ‘tweaked’ to improve the user experience.
  5. Asthma has been well-studied from an epidemiologic standpoint. It is the most common chronic illness in children, found in 1/10 of them in the USA with increasing numbers. It impacts society from morbidity, mortality, and financial perspectives. Allergens causing asthma are ubiquitous and have documented to be common in schools according to a study by Boston Children’s Hospital and Harvard Medical School published in JAMA Pediatrics. Interestingly mice allergens were found in 99.5% of school samples. Digital technology in the form of an allergen sensor is commercially available from Alersense (disclosure: the author is an advisor to Alersense). It allows for custom programming of allergen sensor thresholds to alert the user before symptoms may occur.

     Digital health tools are by no means meant to replace clinicians but the potential scale, convenience, support of self-management, potential effects on cost savings and patient reported outcomes are all very significant.  Public health consumes a lot of healthcare resources which as noted above are decreasing.  With an epidemic rise in chronic diseases, the need becomes magnified.  Strives must be made to demonstrate improved outcomes and provide the privacy and safety that patients demand and deserve.

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Five Ways a Good Digital Health Registry Addresses Healthcare System Needs



Registries have traditionally been viewed as static repositories of data to be reviewed in a summary fashion after a predetermined time period.  The expanding need for drilled down relevant data has led to the development of creative sophisticated data analytics technologies.  We have witnessed the transformation of registry data collection which now includes curation of relevant raw data ranging from medical images and pathology slides to genomics.  Clinical or other predetermined data relevant to a given patient can be collected real-time from anywhere the patient is seen, regardless of the data’s EHR vendor of origin. In addition, the way in which the data is viewed real-time can be customized according to the viewer’s profile.  These developments have evolved the registry into a living digital narrative. I will discuss below some of the most useful applications of such exemplary registries.

  1. Provide real-world data for regulators. The Physician Quality Reporting System (PQRS) has been used since 2015 as a metric to determine negative Medicare payment adjustments to providers who do not meet quality standards. Without getting into unnecessary detail, one of the options of providing these metrics is reporting from clinical registries.  These registries are chosen from an approved list of registries.  The FDA has chimed in with a Guidance on the Use of Real-World Data to Support Regulatory Decision-Making for Medical Devices. The FDA recognizes that real-world data “…may be of sufficient quality to help inform or augment FDA’s understanding of the benefit-risk profile of devices at various points in their life cycle…”  Registries therefore have found their strength in reflecting the real world experiences of patients and physicians.  Clinical trials by design are rigorous and closely monitored. Adverse events and effectiveness of therapy many times require longer follow-up with more real world experience (without the restrictions placed by trials) to become known.
  2. Improve patient safety. A corollary to adverse events and efficacy is patient safety. The safety of a medication or device may reflect predictable or unpredictable serious adverse events. It might be a universal issue which is discovered only after a prolonged period of exposure. Examples are found in  the implantable pacemaker and defibrillator and orthopedic device industries or long-term risk of certain medications (ex. anti-inflammatory drugs and risk of heart attack). Registries can collect post-marketing real world data and lead to discovery of patient safety issues significantly in advance of word of mouth communications which have a bias of the threshold of information transmission.
  3. Supplant claims data with more accurate and relevant data. The inferiority of administrative claims data versus clinical registry data has been known for years. Some believe that the use of the more granular ICD-10 diagnostic claims codes will close the accuracy gap between claims and clinical data. I personally do not believe claims data will ever supplant patient reported outcomes (PRO) data because PRO data reflects not only outcomes but the outcome relevant to that patient.  I have previously discussed the importance of PROs. In addition, the aggregation of raw data can even potentially affect disease treatment strategies.  Consider the hypothetical situation in which a cancer registry pairs pathology slide data with imaging, chemistry, genetic, treatment and clinical data from physical examination.  Subgroups of patients might be identified from various combinations of data which benefit from different treatments they received (or didn’t).
  4. Provide a vehicle for PRO standardization. Patient reported outcomes are the key to determining quality. The importance of PROs and their standardization are eloquently discussed in an editorial in the New England Journal of Medicine: “…Experience in other fields suggests that systematic outcomes measurement is the sine qua non of value improvement. It is also essential to all true value-based reimbursement models being discussed or implemented in health care. The lack of outcomes measurement has slowed down reimbursement reform and led to hesitancy among health care providers to embrace accountability for results…”  Data sets derived from registries or any patient portal can be used in the development of PRO standards.  In addition, the data can be compared real-time to existing international standards thereby facilitating changes in treatment strategy earlier than would otherwise be guided by government reported analytics via feedback many months later. One might hypothesize that the visualization of data relevant to them compared to others who achieved best outcomes standards by patients via self-management platform portals might affect changes.
  5. Real-world patient reported data for price support of effective new drugs.  Many specialty medications notably biologics are very expensive. They obtain FDA approval and are priced out of reach for most patients.  They are denied reimbursement by many insurance carriers either outright or via impossible barriers to overcome.  A prime example is reimbursement for new injectable cholesterol medications for refractory familial hypercholesterolemia (which is not rare with an estimated prevalence of 1:200 Americans and as high as 1:60 persons in central Pennsylvania).  Some carriers require genetic testing to document a diagnosis (though the diagnosis can be made via significantly high blood levels alone), but won’t pay for the genetic testing which costs $2-3K dollars. Would payers rather pay for heart bypass surgery? Post-marketing patient registries which provide patient reported outcomes could significantly lower drug costs by providing data showing better efficacy than the approval studies.  This might tip the benefit-cost ratio for payers to support a drug or other treatment’s cost.

As one can see, registries performed with quality technologies can have profound effects on healthcare from many standpoints. Investment in digital tools which make Big Data come alive and transform it into relevant data can be helpful to all healthcare stakeholders. One must see this as an ROI for cost savings at its finest.

 

 

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