Why Home Care is More Important than Readmission Rates: Implications for Digital Health Technologies

The Affordable Care Act added a section to the Social Security Act known which established the Hospital Readmissions Reduction Program. Under the new fines as described in an article by Kaiser Health News, three-quarters of eligible hospitals will be fined in the program’s third year. Fines totaling $428M will be levied from payments of Medicare patients, not limited to those who were readmitted. I first wrote about the role of  role of digital health tools in reducing readmissions in 2011 prior to the program going into effect. Digital tools have been since been developed for providers and offered by entities including the Agency for Healthcare Research and Quality . Technology is being touted as a savior for readmission penalty reduction. But as I have stated many times, technology offers tools which only become solutions in the context of processes involving humans and aimed at solving specific problems. The topic of hospital readmissions is important because no one wants to rebound back into a hospital after a serious illness but popular primarily because of its financial implications. These regulations are part of the historical Medicare-provider cat and mouse reimbursement game that has been taking place for decades. But I digress. Patients and caregivers today are more concerned about what support THEY have when discharged from a hospital as well as that which can help them avoid an initial hospitalization.

Information regarding coverage home care in the USA is available at Medicare and Home Care. An interesting comprehensive overview Home Care Across Europe furnishes information comparing needs and services among nations. Home care is more important than Readmission data because:

  1. It can affect initial as well as repeat hospitalizations. The focus of readmission rates misses the point of what got the patient in the hospital in the first place. The management of a chronic disease is regarded as more important than its prevention (or at least the prevention of its presenting complications). Digital patient education tools might succeed where verbal encounters and/or written materials haven’t. Digital tools in the form of apps are ideally interactive, can easily be shared with caregivers, contain incentives and have a social component.
  2. It applies to people of all ages, not just patients. As we now know too well, chronic diseases are beginning in childhood, linked to unhealthy lifestyle behaviors. Young people are all digitally ‘connected’.  Therefore digital tools are likely the best (and possibly the only) way to engage them.  Addressing chronic disease prevention in young people is the biggest and best investment in healthcare. Addressing the readmission problem, primarily in the Medicare population misses the boat with regards to population health management and the potential for digital tools in other groups. Aging at home should be applied to ALL ages (after all aging, by definition, is a lifelong process).
  3. The implications for the economy and healthcare outcomes are greater. Thinking of hospital readmissions certainly has the patient as a focus, but limiting the readmission time to 30 or 90 days is really not addressing the core problem which is how to institute processes at home which lead to better outcomes. The importance of medication literacy and reconciliation and prompt follow-up appointments are self-evident. Social workers do their best to assure adequate home health concerns are addressed, but they are limited in purpose to meeting regulatory requirements which many times have nothing to do with the patient’s individual needs or ability to meet them financially. The threshold for furnishing adequate care is many times dictated in an all or nothing fashion based on whether the patient is on Medicaid or not.
  4. The market for digital health technologies is greater. People who are not recovering from a recent hospitalization require less acute monitoring. Devices which are directed towards wellness or the prevention of complications of chronic diseases (as opposed to actually managing the chronic disease) have been declared not necessary for regulation by the FDA. This opens the market for less costly (and potentially more impactful) mobile technologies.
  5. The impact on caregivers is greater. According to a report by the AARP Policy Insititute,  the ‘caregiver support ratio’ will dramatically plunge. Between 2010 and 2030, the population between 45 and 64 years old will increase by 1% while those over 80 will increase by 79%. The ratio is expected to drop from 7 potential caregivers for every high risk person (over 80 years old) to 4 to 1. Aging at home is where the rubber meets the road for caregivers. While the patient is recovering from a recent hospitalization, Medicare pays for some home health services (though woefully little with legislation which continues to decrease services). Digital tools including apps will one day deliver informational resources, logistical help with medical equipment, health aid scheduling and visiting nurse assessment and care. While apps today don’t cover much of this, there is a growing group of apps geared to caregivers. Some examples are: Balance: for Alzheimer’s caregivers, Care Zone, Elder 411, and CarePartners Mobile. Online web-based tools include:  http://tyze.com/. Apps for caregivers have begun to attract general media attention.  Aging at home is by far a bigger issue for patients and families than readmissions because of the longer-term benefits to all involved.  Sure, readmissions disrupt life but aging at home is what we think about more and deserves more attention.  Payers including the government need to make aging at home, not an institution, the focus of resources and investment.  It’s what Baby Boomers who are becoming seniors of the present and future will demand.
Posted in death and dying, digital health, health insurance, healthcare economics, Healthcare IT, healthcare reform, media coverage, medical apps, mHealth, mobile health, patient engagement, pharma, remote patient monitoring, smartphone apps | Tagged , , , , , , , , | 1 Comment

The Hospital Discharge Process: A Call for Technology’s Help?

While being discharged from the hospital even after a minor procedure is not simple (due to regulatory documentation requirements often hard for both patients and physicians to sift through), the process for a patient with co-morbidities after a prolonged stay is daunting.  There are physicians from multiple specialties, various non-physician providers, social worker, and the case manager, all of whom address different discharge-related issues.  It is frustrating for both a provider and patient to experience the “I really can’t answer that question” moment. Lack of effective interdisciplinary communication may lead to medical errors, and either premature or delayed discharges. The date of discharge is estimated soon after admission. Some hospitals have a focus on the clock when planning discharges. If planning occurs too early, it does not account for changes in patient needs and wrong instructions might be given. Transportation and home aid needs are time-sensitive. In contrast, some planning needs to be considered early in the admission when discharge to a non-acute care facility is obvious due to the diagnosis and/or social situation of the patient. One recent study in JAMA from the Brigham and Women’s Hospital identified seven clinical factors predicting hospital readmission: a hemoglobin less than 12 g/dL on discharge, discharge from an oncology service, low serum sodium level on discharge, a procedure (via ICD-9 standards) during admission, non-elective admission, length of stay > 4 days, and number of admissions during the previous year.  Another study examined many predictive models found in the literature.  “Of 7843 citations reviewed, 30 studies of 26 unique models met the inclusion criteria. The most common outcome used was 30-day readmission; only 1 model specifically addressed preventable readmissions. Fourteen models that relied on retrospective administrative data could be potentially used to risk-adjust readmission rates for hospital comparison; of these, 9 were tested in large US populations and had poor discriminative ability…Seven models could potentially be used to identify high-risk patients for intervention early during a hospitalization …, and 5 could be used at hospital discharge…” The study’s conclusion was that most prediction models perform poorly or require improvement. Perhaps one reason for this result lies in the fact that these models traditionally either fall into a clinical or administrative model. I believe that better success might be achieved if administrative and clinical predictive models are combined. Better analytics programs applied real-time in the EHR will facilitate integration of these  perspectives.

The topic of transitional care has received attention because a poor discharge process results in higher readmission rates, a new benchmark focus of Medicare. Hospitals might be very good at meeting regulatory requirements  but the patient’s understanding of diagnoses and instructions (both care and follow-up) is often not clear.  Though required via regulations, the caregiver may not even be included in the process.  I will discuss areas which can benefit from technology. Some of the technology mentioned below might not necessarily be available in the context described but feasible.

  1. Durable equipment needs: The care coordinator is generally the point person regarding the patient’s durable equipment needs upon discharge. Ordering the equipment (specifications and date, time, and place of delivery) might be the job of someone else (therapist, physician). Digital tools can expedite equipment procurement. Analytics from the EHR (mining diagnoses, equipment in use at the end of the hospitalization, expected place of transition, etc) might determine the individual’s ambulation, oxygen, bed, or other equipment requirements. This can act as a preliminary checklist from which the coordinator can start, rather than personally going through the EHR or surveying providers. A digital ordering program can directly interact with the distributor to check product availability and verify delivery. Another useful tool would aggregate equipment distributors which are stratified according to certification (Medicare bidding approval status), cheapest price, and best rated service (by patients and/or institutions).
  2. Visiting nurses: Often the home needs assessment for visiting nurses is done once the patient is discharged. This can be expedited with the help of a caregiver with the assessment completed in the hospital. Consider a tool into which the physician’s orders or recommendations for home nursing are placed and shared with the visiting nurse entity, the patient, and the caregiver. It would include the nursing assessment, and a video of the home environment (a factor in the assessment itself). This would obviate the need for a dedicated assessment visit. Visiting nurses themselves should be equipped with mobile technology which would: document their time schedule for billing, interventions, record and transmit vital signs (measured via digital remote monitors), orders, and contain a digital messaging program.
  3. Scheduling of outpatient provider appointments: Although there is some evidence that in a general medical population early follow-up appointments do not impact readmission rates(notwithstanding a slightly higher emergency department visit and death rate), some patient including those with congestive heart failure  have been shown to benefit from early follow-up. The success of a growing number of commercially available mobile apps intended to streamline scheduling of physician appointments is testimony to the need it is addressing in the non-acute setting.  Patient portal use is a requirement of EHR’s Meaningful Use Stage 2. One way of encouraging patient participation in portal use would be activating it by utilizing a discharge planning scheduling application of the portal at the time of discharge. This fits into an overall strategy of point of engagement implementation of technology.

These are only a few highlights of the complexity of the discharge process. All physicians have dealt with the many questions, complications, and frustration experienced by patients after discharge. A failed process creates unnecessary work, expense and bad outcomes.  Digital health technology’s image to many physicians is represented by the EHR in its present form, which is not what the doctor ordered. It is not intuitive, cumbersome, and encourages impersonal encounters with patients. I will explore in future posts how digital technologies other than the EHR will change medicine in ways that physicians will appreciate them.

Posted in digital health, healthcare economics, Healthcare IT, medical apps, palliative care, patient engagement, remote patient monitoring, smartphone apps, wireless health | Tagged , , , , , , , | 4 Comments

Five Ways Telehealth will Change Medicine

When discussing telehealth, one first needs to refer to definitions. The Health Resources Services Administration defines telehealth as “The use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration.”  It is differentiated from telemedicine which is focused on remote clinical services. Telehealth today is most commonly associated with video conferencing between a provider and patient. However healthcare encompasses more than the encounter and includes support processes and tools which will hopefully contribute to better outcomes. Electronic health records and interoperability of examination tools with video technology now permit a virtual exam similar to an in-person one. There are now well-defined clinical practice guidelines for telehealth by the American Telehealth Association.  I will discuss ways in which telehealth will provide benefits to both patients and providers.

  1. Telehealth will place the patient as the focal point of care. It is all too apparent that the patient encounter is not what it used to be. Regardless of its duration, there are measures the provider can take to improve the quality of the encounter. Physicians are frustrated by spending more time with the computer than with patients. Nurses too are frustrated with the decrease in direct patient care due to increased time spent with computers. Telehealth video conferencing technology puts emphasis on the literal face to face encounter. It therefore by default puts the patient as the focal point of the encounter. A provider would likely feel more self-conscious looking at a computer and not the patient on the screen in this setting. This technology places the provider outside of his normal comfort zone of the exam room.  A telehealth visit has patients more comfortable in their own environment with the provider as a (virtual) guest.
  2. Telehealth will close gaps in care. Coverage for telehealth varies by state in the USA. Medicare coverage for these services are limited to geographical regions defined by the HHS “…when the originating site (where the patient is) is in a Health Professional Shortage Area (HPSA) or in a county that is outside of any Metropolitan Statistical Area (MSA), defined by HRSA and the Census Bureau, respectively.” While one can understand the utility of closing care access gaps, the gaps themselves have widened over time to include larger and more urban populations. Shortages of certain specialties, most notably mental health are now glaring. In addition, the time and financial costs incurred by the patient and caregiver of an office visit can be markedly decreased with telehealth.
  3. Telehealth will reintroduce humanism back into medicine. I believe that telehealth will demand improvements of providers’ interpersonal skills. The ease of use I believe will likely increase the number of provider interactions, supplemented with data transmitted via other technologies(see below). Telehealth will be expanded to include providers other than physicians as a natural extension of existing care team models. Telehealth will eliminate the ‘routine office visit’ which provides an often useless and uninformative snapshot of clinical time. The encounter will therefore be more need-driven and by extension meaningful. The availability of caregivers to participate in a telehealth encounter will be greater (perhaps even via technology allowing triangulation). There are even capabilities of telehealth visits transmitted from the primary care office room to a specialist. Convenience, less provider distraction, and a more relaxed patient in a familiar environment all support a more humanistic ‘meeting.’
  4. Telehealth will accelerate the use of mobile health technologies. Though one’s first thought of telehealth brings back a vision of a console television from the 1960’s, we are already at a point where telehealth is mobile. A pioneer in this arena is 3GDoctor. Established companies like Verizon have entered the virtual mobile health visit space. Telehealth has been around for about 40 years. Regulators and payers are revisiting telehealth and familiarizing themselves with all mobile health technologies in their efforts to implement tools which can ease pain points in healthcare delivery. The association of mobile health tools with telehealth, the ‘mobilization’ of telehealth itself, and the present adoption of telehealth by healthcare enterprises on a widespread scale will all accelerate the implementation of mobile health strategies. Telehealth adoption is being driven by shortages of specialists in the fields of mental health, neurology, intensive care, and dermatology. Payers are expanding coverage and providers are getting acclimated to remote-based technologies. There is more interoperability with digital IT with telehealth relative to mobile technologies. Mobile health technologies will benefit as a result of all of these factors.
  5.  Telehealth will increase practice options for providers. From a provider standpoint, telehealth might usher in a new type of practitioner. Physicians and other providers might be required to achieve added qualifications in telemedicine. Those drawn to the combination of technology and ‘direct’ patient care might be drawn to telemedicine. Providers will care for patients virtually in different geographical areas, potentially leading to a more enriching professional experience.

I look forward to telehealth becoming a more significant part of mainstream healthcare and to the trails it is blazing for mobile health in general. Ideally I would envision the ATA working with HIMSS to further the cause of the highest quality of care that all digital technologies may provide. From a clinical standpoint they will all be used in a complimentary fashion. For further reading, I would recommend a review by the Information and Technology and Innovation Foundation.


Posted in death and dying, EHR, healthcare economics, Healthcare IT | Tagged , , , , , , , , | 2 Comments

Five Reasons Why Digital Pharma Needs Physician Key Opinion Leaders

Physician key opinion leaders (KOLs) have been viewed as a valuable resource in the pharmaceutical (heretofore referred to as Pharma but included are medical device companies) industry. In one study in which 100 KOLS were surveyed, the most important characteristics of a KOL were: “regularly sought out by their colleagues for opinions or advice, speak often at regional or national conferences have published articles in a major journal during the past two years, consider themselves early adopters of new treatments or procedures and help establish protocols for patient care.” In another survey of KOLs in endocrinology taken in 2011, by Thought Leader Select, a KOL consulting firm, 70 percent of veteran KOLs reported that they preferred and expected contact primarily with industry executives or a medical science liaison, versus sales or marketing. Digital Pharma devoted approximately 3% of marketing budgets to Digital in 2013. But did anyone ten years ago think that 60% of retail sales would be via the Internet? Digital Pharma marketing currently is generally categorized as patient-focused or physician-focused. There should be a third and possibly even more effective strategy, that of targeting the patient-physician engagement team. Multichannel marketing will thus also include hybrid customer group marketing.  Physician KOLs will blaze the trail laying the foundation for provider acceptance of shared decision-making. Pharma is in a unique position to facilitate adoption of patient engagement on both provider and patient fronts. Payers can do this but not as easily on a mobile digital level and not easily at the point of care. These new KOLs will not displace traditional ones but will compliment them.  There will be segments of both provider and patient populations which are less (hopefully just initially) receptive to digitally-based marketing tools. These KOLs will have respect by peers on a medical level and will be faces of patient advocacy. They will help physicians adopt the tools as well as work with digital technology tool clinical investigators. I would like to discuss some fundamental arguments for the establishment of physician Digital KOLs.

  1. The efficacy of mobile apps should be evaluated with clinical studies. This will be a new necessary focus of healthcare in the future, from both marketing and clinical outcome perspectives. Mobile apps directed at disease management will likely find themselves on formularies of payers as well as hospitals, similar to drug formularies. One expects that positioning on such lists will be tied to clinical effectiveness (and cost to a much lesser degree than drugs or devices). Clinicians will always ask “Has it been shown to work?” Physician Digital KOLs are those who will present the proof. They will be developing and leading studies (at much less cost and regulatory hurdles than drugs)  which evaluate both clinical outcome as well as the user (provider, patient, and caregiver) experience aspect.
  2. Physicians are at the crossroads of all things medical and Digital. The EHR is seen as the Digital hub of healthcare today. At one point in time this will no doubt shift to the patient portal. The patient portal will ideally become the gateway to connected health data from wireless glucometers, vital sign monitors, more sophisticated sensors, and other patient-derived filtered data. A patient-facing Digital tool will have maximal success of adoption and adherence if recommended by a physician. The clinical loop around the app (pertinent actionable data provided by the patient and hopefully generated treatment recommendations) will necessarily flow through the clinician via the EHR.
  3. KOLs provide the best insight into clinical and workflow problems addressed by digital tools. There is no more obvious an example of a potentially great digital tool that has not been well-received because of its difficulty in conforming to clinical work flow than the electronic health record. It was designed to address regulatory and reimbursement issues, not conform to the way care itself is delivered. Success of digital tools is dependent upon their insertion into clinical workflow (best done at the point of care). In addition,  processes need to be in place to support the tools. Patient behavior determines whether the tool is downloaded and revisited. Adherence is not a new problem. However I would submit that determinants of adherence to medications differ from those of a digital tool. Knowledge about the user experience, connected IT issues, and the education of an entire provider community about mobile health in general are unique to Digital. The impactful integration of a comprehensive digital strategy into Pharma will take years. It will accelerate with the partnership of Pharma companies with other disciplines (mobile health, behaviorists, user experience specialists) and the presence of physician KOLs.
  4. It’s not about the product; it’s about the human experience. As noted above, success of digital tools ultimately hinges on behavior tied to patients consistently using the digital tool and viewing it as a beneficial part of the life experience, translating into enduring motivation. The physician is the human element between the digital tool and the patient. They must be an integral part of delivering the tool and providing the environment in which the digital experience is nurtured and developed. Empathy (much lacking in healthcare today) can be transmitted to a patient only via a human interaction. Suggesting a digital tool to the patient or caregiver conveys empathy by engaging the patient in new ways. KOLs can provide the support, encouragement, and clinical rationale for the adoption of these technologies to their peers. In this way, the human experience of the provider using these tools is improved as well.
  5. Patient engagement necessarily involves the physician. Patient engagement can best be defined as “actions individuals must take to obtain the greatest benefit of healthcare services available to them.” Implicit in this definition is that the best information (and tools communicating it) has been supplied to the patient. The best patient care includes shared decision-making by an engaged patient. The physician closes the loop and is a therefore a critical component of the patient engagement tool. Physician Digital KOLs are most appreciative of the role of digital tools in the developing focus of patient engagement. A tool is a solution only if used in a context of patient engagement. Teaching how these tools can therefore be turned into solutions by providers is the mission of physician Digital KOLs.

It is clear that Pharma sees the patient (and the public) as customers. If the ‘sale’ is disease state awareness, that can be accomplished (within the framework of digital and health literacy considerations).  However, the next step is adoption (i.e. filling the prescription) and then adherence. Here is where the rubber needs to meet the road. Digital will succeed (on many fronts) more than traditional channels. However, a new breed of marketer as well as KOL is needed. I call upon Pharma to help take patient engagement to the next step via a new unique marketing strategy.

Posted in digital health, FDA, healthcare economics, Healthcare IT, informatics, medical apps, mHealth, mobile health, patient advocacy, patient engagement, remote patient monitoring, technology | Tagged , , , , , , , , , , , , | 3 Comments

Five Reasons Why Physician IT Champions are Needed

It has been 5 years since the passage of the HITECH Act portion of the Affordable Care Act. The purpose of HITECH was “…to promote the adoption and meaningful use of health information technology.” While the result of this legislation has been the significant increase in the adoption of EHRs, most of the potential benefits of digital technology have yet to be demonstrated. there are multiple reasons for this lack of proof. Firstly, the portions of Meaningful Use directed at patient management (versus documentation) have not been fully implemented. In addition, According to an excellent report ‘Lessons from the Literature on Electronic Health Record implementation’ by The Urban Institute, “…Training best practices include obtaining organizational commitment to invest in training, assessing users’ skills and training needs, selecting appropriate training staff, matching training to users’ needs, using multiple training approaches, leveraging the skills of role models (clinical leaders, champions, super-users, training coordinators), providing training support throughout the implementation process, and retraining to optimize use of the EHR…” I would like to focus on the physician IT champion (either on an enterprise or office level) as a key component of this strategy. The role of the physician IT champion is to keep physicians up to date on the changes to the EHR and for maintaining physician “buy-in” to ongoing improvement projects involving the EHR.

  1. There will be improvement and expansion of Digital healthcare technology. The EHR is among the first large scale forays of Digital into mainstream healthcare (imaging was first). The near future will see expansion to include mobile medical apps and telehealth. I believe that standardization of EHRs, the growing focus on development of mobile health strategies (as described in the 3rd Annual HIMSS Analytics Mobile Survey), and a large body of pending telehealth legislation will all accelerate this expansion. Physician IT champions will assist in implementation of the EHR as well as integration of these new interoperable pieces. Home grown enterprise IT projects involving  analytics, clinical decision support tools, registries or any combination of these requires an intermediary between the IT department and clinicians during both  development and implementation.
  2. EHRs will continue to become more complex. As EHRs incorporate more data related to either regulatory requirements or changes in the IT structure, physicians who are operating on marginal familiarity with the system will become overwhelmed. The more familiar one is with the basic unit of operation, the easier transitions will become. The IT champion is the clinical face of IT in the trenches. Interacting with champions with good communication skills, knowledge base, and empathy will be the difference between an IT success and failure. The imperative of implementing more complex IT integrations across increasing numbers of affiliated care entities (either within an enterprise or as part of an ACO) will benefit from physician IT champions who can support local clinical IT leaders. Many enterprises are now either using or shopping for their second EHR system for various reasons. As more complex regulatory requirements are mandated in later stages of Meaningful Use, the role of physician IT champions will by necessity increase to assure success.
  3. EHR buy-in is a trickle down phenomenon. Physicians are the leaders of the healthcare team. An unhappy leader is detrimental to patient care in multiple ways. Frustration and anger directed toward the EHR sends a message to other team members including clinical and clerical, discouraging them from embracing, customizing, and respecting the technology. This in turn can increase risk of privacy breaches, mistakes in data input and transfer, and ultimately clinical errors, all of which are risk management liabilities. A physician who is not well-trained has an increased chance of misguidedly having a negative attitude towards the technology. In turn, the opportunity to transmit good IT practice (which makes it a better user experience) to junior or new team members will be lost.
  4. Quality of patient care is at stake. The EHR is fertile ground for both improving care and for making clinical mistakes. The old adage ‘Garbage in, garbage out’ is no truer than when applied to the EHR. An IT champion sending the message that good IT practice will not only make care easier but safer, with the patient always at the center of the discussion, will garner the loyalty of all providers. There are many limitations of present day EHRs which are barriers to optimal patient care. This will change over time and IT champions will be on the forefront of providing those improvements either within existing systems or conveying user recommendations for newer systems. Establishment of this relationship gives IT leadership a clinical face which providers can relate to. I see it analogous to a neighborhood with a foot patrol police presence.
  5. The physician champion role is not a new one. The institution of physician champions in the clinical arena has been shown to be successful. Extension of this concept to the IT sector is a welcomed prospect when one considers that the EHR was unfamiliar territory initially to most physicians. The combination of limited initial training, ongoing time constraints, and increasing complexity beg for creation of such a role. Physicians have been familiar with the role of key opinion leader and other physician leadership roles. The IT champion would be among the most appreciated of all.

The AMA recently issued an executive summary entitled ‘Improving Care: Priorities to Improve Electronic Health Record Usability.’ This identifies concerns that the EHR vendors should address. The implementation of a system including physician IT champions addresses issues which users need to improve upon to maximize benefits and minimize liabilities. More importantly, better EHR usability facilitated by the IT champion can improve physician job satisfaction.

Posted in digital health, EHR, healthcare economics, Healthcare IT, healthcare reform, healthcare vendors, IT security, technology | Tagged , , , , , , , , | 1 Comment

Five Imperatives for Pharma’s Digital Health Strategy

Few would argue that today digital technology represents a critical part of marketing in any business sector.  Though all healthcare stakeholders are usually late to the technology table, market and customer pressure are rapidly accelerating this adoption. It needs to be emphasized that technologies are not solutions. They must be incorporated into human workflow processes To do so in healthcare, culture must change, specifically with regards to patient participation, shared decision making, and the acceptance of mobile health tools. Digital has been cited as a marketing strategy for Pharma. However, a true strategy must embrace the introspective examination of key issues. Who is the customer? What is the role of Digital in overall corporate strategy? How do we shift from the traditional marketing and sales infrastructure, strategy, and metrics to one in which digital technologies are incorporated into all corporate silos? I submit that Digital must be an integral part of the foundation of Pharma from R & D and clinical trials to marketing and sales. Relegating Digital to a separate division implies that it is competing for global corporate resources and that it is an end to itself. I will discuss what is necessary to a true Digital strategy.

  1. Business partners. Pharma companies are not IT companies. In a recent survey of Pharma marketers by COUCH, 92% were unsatisfied with their company’s digital implementation. The majority of responders found the biggest challenges were in the areas of expertise, innovation, and creativity. Marketing in the digital world involves many moving parts. In my view there is not a clear path to the customer. Given the resources devoted to DTC marketing programs and topics at industry conferences, it is evident that Pharma now views the patient as the primary customer. While education to physicians and other providers continues, we see regulatory and logistical barriers restraining those traditional channels. In addition, physicians are being restricted by payers with regards to prescribing, but patients are the consumer, determining if they might be willing to pay more for a given costlier drug. Whoever the marketing target is however, the digital path is not as direct as traditional marketing. Digital is a ‘pull’ (by the customer), not a ‘push’ (by Pharma). The customer needs to be engaged at the point of care where it is most relevant. Mobile health tech requires new business models. For example, from an operations standpoint, there are excellent mobile tools like Prolifiq which can transform the way a life sciences company does business both from an operations and marketing/sales perspectives. Digital strategies should include partnering with companies which address complimentary aspects of a given disease. For example companies marketing anticoagulants for atrial fibrillation should partner with medical device companies identifying these patients with remote cardiac monitoring. It is not hard to introduce a digital marketing tool, but there is a significant difference between introduction and adoption.
  2. Apps. I have previously discussed why Pharma needs mobile apps. The release of the FDA Guidance of mobile medical apps was long-awaited by Pharma. There are individuals and companies specializing in aspects of mobile health which will make apps appealing and therefore enduring. Partnering opportunities with user experience and behavioral experts who understand how content can be delivered in ways that optimize esthetics, patient behavior, and clinical workflow is mandatory. Apps delivered via mobile devices at the bedside could help patients understand their diagnoses and medications better prior to discharge. Tools targeted at caregivers who are more connected via smartphones must be an essential piece of the strategy. With a rapidly increasingly aging population with baby boomers hitting the Medicare threshold, this will become less of an issue. Much has been written about the increasingly blurred lines between consumer and medical apps. Apple’s HealthKit is attempting to merge the two. Pharma would do well to partner with companies like this to deliver their apps in a context of patient management, not specific disease management. This is critical to app adoption because patients with chronic disease need digital platforms which address all their comobidities, not just one aspect of their health. A one stop shopping for apps is much more appealing than a device filled with icons. This is another (and probably the strongest) argument for business partnering as mentioned above.
  3. Digital physician KOLs, work w/professional societies to develop apps:  My favorite definition of patient engagement is that of the Center for Advancing Health which is “the actions that individuals must take to obtain the greatest benefit from the healthcare services available to them.” The greatest benefit of derived care comes from being as well-informed as possible and participating in shared decision-making with the provider. A patient cannot by definition be engaged without an engaged partner. I believe that a DTC marketing approach to apps will not succeed. The root causes of chronic diseases are well-known and rooted in lifestyle behavior. Physicians are uniquely qualified and situated to assist patients in changing behavior.  To leave them out of the loop would be a fundamental flaw in marketing. Physicians will be the Digital crossroads of patient-facing apps, provider-facing Pharma apps, the EHR, the patient portal, the payer, and the pharmacy. Digital content prescribed by providers will accomplish multiple goals. It will assure the provider that the content is reliable and (hopefully) adherent to privacy and security standards. The provider will know that only filtered actionable data will be transmitted (with other data accessible). Therefore, the idea of partnering with physicians via Digital key opinion leaders, the development and clinical trialing of efficacy of apps in association with professional medical societies should be cornerstones of a Pharma Digital strategy. Working within these traditional pipeline models, Digital can be adopted as quickly as possible.
  4. Social Media. This is where the action is in Digital. Successful apps of all categories have Social as a core component of the app. The most successful apps have a social network as a core component. Social is a prime motivator to return to the app, in addition to meeting peers to share the most difficult aspect of being a patient, navigating the healthcare system. This need for Social is the basis for the success of online patient support groups. These groups are potential sources of data which can be extrapolated and grouped according to disease states. This has been uniquely well done by Liquid Grids. While privacy issues are paramount (and a cornerstone of these online groups) I believe that
  5. Sharing data for population studies. Big Data is useless unless good Analytics are associated with it, bringing it to life by creating a story and making the data actionable. The combination of point of care content, Mobile and Analytics will be what truly changes healthcare in Digital.

There are obviously regulatory issues involved in all of the aforementioned imperatives. However, guidelines are in place for all of them and I do not see impediments for successful implementation of them. This list is not meant to be exhaustive but to serve as initial discussion points in broadening the vision of what is perceived today as Pharma’s existing Digital strategy.

Posted in clinical trials, digital health, FDA, healthcare economics, Healthcare IT, medical apps, mHealth, patient advocacy, patient engagement, pharma, technology, telehealth, wireless health | Tagged , , , , , , , , , | 5 Comments

Five Ways Digital Health Technology Can Impact Risk Management

There has been a significant amount of well-deserved publicity regarding HIPAA violations arising from security breaches of electronic health records (EHRs). Even a well-intentioned company which developed a certification process (which included privacy and security) for mobile medical apps encountered its own vulnerabilities. The practice of copy and pasting of EHRs has garnered attention from the government which has investigated its use in the context of fraud.  In response to this, the American Health Information Management Association (AHIMA) issued a paper on  Appropriate Use of the Copy and Paste Functionality. Just as there are risk management issues like those just mentioned, digital health technologies can also be used to mitigate risk. Some of these have been discussed at length in both IT and risk management forums.  However, when examining the subject from a clinical perspective, one can identify opportunities for risk prevention which have heretofore not been approached in a proactive manner. I will attempt to set forth a brief risk prevention strategy utilizing technologies and processes currently available. As a disclosure, I have no financial relationship with any commercial entities mentioned.

1. Patient education. Gordon Gekko in the movie ‘Wall Street’ stated that information is the most valuable commodity. Certainly this applies to a patient as well. The overused term ‘patient engagement’ implies optimization of the patient’s ability to take fullest advantage of the healthcare options available. This is based in my view on two principles; that the best information is made available (along with provider recommendations) and that the decision making process is shared. Digitally prescribed patient education tools such as that offered by Emmi Solutions are the future of digital patient education. It provides guideline –derived visual and animated material and is designed with informed consent requirements in mind. The provider can track how many times, for how long, and what segments of the material the patient and/or caregiver viewed. This type of patient education as well as the documentation of patient participation will understandably mitigate risk pertaining to informed consent issues.

2. Patient navigation tools. Apps which help patients find physicians and book an appointment, check ER waiting times, provide hospital directories are some examples of apps which are consumer oriented. Others such as The Mayo Clinic Health Community provide information as well as social networking. There is an app to help determine and record advance directives. The need for apps which help people navigate healthcare-related governmental services is significant. Though most seniors now lack smartphones, caregivers have them. THEY are the forgotten critical component of the provider-patient relationship. Navigation tools can also be in the form of online patient support groups. Some noteworthy ones are Smart PatientsTreatment diaries, and I have previously described why navigating the health care system is more important than healthcare delivery itself. Frustrations from patients and caregivers are felt even before a first office visit or before an ER doc sees a patient. Having tools which make the process easier is something everyone would appreciate, translating into risk mitigation.

3. Real time HCAHPS surveys. HCAHPS surveys are patient surveys which measure patient satisfaction. Hospital reimbursement is tied to these survey results. Whatever one might think about the merits of satisfaction-tied reimbursement is, the process itself is extremely flawed. Patients receive the detailed survey weeks after a hospitalization and the data (for evaluation and comparison to similar facilities) is only available almost a year later. Hospitals therefore cannot improve (or to address a patient’s needs) until way after the fact. Having real-time surveys available to be taken on a tablet at the bedside (after each phase of hospitalization: ER, surgery, etc) might facilitate better communications and more timely corrective measures. Companies like HCXperience saw a need for a real-time tool years ago. Medicare regulations do not accommodate such tools at the present time. Having real-time feedback from patients might very well mitigate risk.

4.‘Connecting’ patients. Having patients ‘connected’ at the bedside can mitigate risk in a number of ways. Wouldn’t it be nice to know if a patient spikes a fever 3 hrs and 59 minutes before the next set of vital signs is taken? Continuous vital sign monitoring (made available on the provider’s mobile device) thus has intuitive risk mitigation implications. In addition, there are digital technologies, Patients ‘connected’ in other ways also mitigates risk. The key to success of many digital health tools is that they are deployed at the point of care. The utilization of a mobile device to record patient information, transmit it, and communicate with providers saves time, efficiency, and decreases the risk of error. Patientsafe solutions is one example of a mobile health company developed to answer practical clinical safety issues. Another way to mitigate risk is for increased hospitalized patient satisfaction with improved communications and services delivered via bedside patient mobile devices. On another note regarding connected patients, it must be said that patients will be increasingly remotely monitored from home by devices transmitting data consisting of vital signs, diary entries, and other health and demographic information via wireless devices. Care must be taken to investigate from technical and policy standpoints what has been done to protect patients from the manufacturer and app developer sides.

5. BYOD: The elephant in the room: According to a 2013 report by Cisco, 89% of healthcare BYODers (those who bring their own [mobile] device to work, perform work from their smartphone and 40% of them don’t have these phones protected with a password. In addition, 53% of the workers access unsecured wireless networks with these phones. Measures used to improve security of data on these devices were examined in the 3rd annual HIMSS Analytics survey. 98% of those surveyed (most were persons in positions of IT responsibility for an organization) used password protection, 71% used data encryption, 69% utilized remote wipe capability, 15% had automated data disintegration and 9% had biometric ID programs. Surprisingly 29% stated that mobile devices retain personal health information. Having a BYOD policy Policy and procedure risks include the absence of an “acceptable use” policy, lack of privacy breach protocols, and not having a minimum password requirement.  Most security breaches result from errors in human behavior and not the result of hackers. A BYOD policy is therefore critical to proactively mitigate risk. Adequate security policy training on all levels of employment in the enterprise cannot be overstated either.

     Digital health technology is a daunting consideration from a risk management standpoint. This is due to the fact that consequences are high and the risk is not appreciated until there is a breach. However, as I hoped to have conveyed, digital technology can also be used to decrease risk by improving patient safety, enhancing communication and patient care, and by giving patients tools they need to become engaged. Let us embrace technology and use it to protect us. However, this too boils down to human behavior related to implementing both best technologies and practices built around them.



Posted in digital health, FDA, Healthcare IT, IT security, malpractice law, mHealth, mobile health, patient engagement, remote patient monitoring, risk management, smartphone apps, telehealth | Tagged , , , , , , , , | 1 Comment

Aging at Home: A Necessary Synergy with Digital Health Technology

References to new healthcare delivery models today generally refer to systematic changes which reflect reimbursement strategy shifts. Some even go so far as to refer to them as innovations in healthcare design. I would take issue with labeling these new changes as innovative. These changes in care delivery are organizational. It must be said that patient-centric care differs from patient-centered care. Successful business models will be those designed around point of care patient interactions. A few years ago I described how business models of mobile health might be designed around the technology. It is just as important to have the technology designed around the business model which will reflect the care model, not vice versa as suggested in the first references above.

To be more specific, healthcare will be generally focused in the home. The National Institute on Aging’s website suggests ways in which the elderly can be helped at home. Unfortunately, it is designed for those who can afford total care, whether it be medical or non-medical aid. The site states that “…Some might be covered by Medicare…” It neglects to say that almost none if it is. Medicare resources need to be shifted from fee for service for high hospital reimbursements to reimbursement for total care which includes (and should be heavily weighted towards) home care. Most of all, it should be patient-specific (and should include older persons who are the ‘walking well’), not diagnosis-driven. Aging at home should include technologies aimed at preventive medicine efforts hopefully minimizing readmissions as well as non-medical support for both patients and caregivers. These issues were elegantly addressed by the European Union’s “Quality Care for Quality Aging” project.

Technologies which can aid the elderly and sick at home should be reimbursed, independent of an event such as a recent hospitalization. The technology should meet some minimal requirements. I was deeply moved by the movie Alive Inside which chronicles the effect of music on memory in patients with dementia. Music memories have been found to be the last ones to disappear in dementia patients. It activates more areas of the brain than any other sensory input. Private money is being raised to by $40 iPods for dementia patients (costing billions less than medications and providing better results). It is sad that red tape, lack of regulatory and budget flexibility, and reliance on traditional reimbursement models impede the rapid adoption of even proven technologies. The FDA has a process of ‘fast tracking’ drug approval. CMS must develop some way of fast tracking approval for reimbursement of digital technologies without necessarily incorporating them into large-scale overhauls of the healthcare system like the HITECH Act or the “Fostering Independence Through Technology Act”.

Technology is certainly available to develop mobile apps which allow caregivers to easily search for a piece of medical equipment from a list of Medicare-designated vendors, with direct price comparisons or which compare prices of different drugs of a given class based on the patient’s Medicare status (in or out of the ‘donut hole’) and supplemental insurance plan if they have one.

Most developed countries have much more extensive assistance available for people to be treated, recover, and live at home than the USA. It reflects cultural views on aging itself. New care models must be developed and the infrastructure which assists caregivers as well as technology to support them must be provided. The technologies already exist and are utilized on national scales. The Center for Technology and Aging’s 2014 report on The New Era of Connected Aging provides many examples of these available technologies. As Baby Boomers are now realizing the limitations of current healthcare models which encourage institutionalization of healthcare and aging, they will be the ones to champion new ones. Let us realize that change can and MUST happen, and let technology fit into the new paradigm of shifting healthcare from the institution to the home where most of us would desire it for ourselves.


Posted in digital health, FDA, health insurance, Healthcare IT, medical apps, medical devices, mHealth, mobile health, patient advocacy, patient engagement, remote patient monitoring, smartphone apps, technology, telehealth | Tagged , , , , , , , , , , , , , , , , | 1 Comment

Five Ways Mobile Health Technologies can Change Healthcare Now

There is growing healthy skepticism about the past promises of mobile technologies.  Issues concerning safety after the release of the FDA Guidance of mobile medical apps, privacy and security, and efficacy. Followers of the sector are poised for the rubber finally meeting the road in healthcare. While most mobile health tools used today are reference apps for healthcare providers and patients, there  are ways in which other types of mobile technologies can be immediately useful.

  1. Mobile real-time HCAHPS surveys. Recently, the government instituted a system of tying hospital (and provider) reimbursement for services to patient satisfaction scores delivered via Hospital Consumer Assessment of Healthcare Providers and Systems While there is significant debate over the correlation of patient satisfaction to quality of care, this system is here to stay at least for a while. One fundamental flaw in the system (which in my opinion makes it a setup for failure, is the marked delay of delivery of the results to institutions. This delay is on the order of 10 months. In addition, surveys may be delivered to patients up to six weeks following discharge. Will someone remember what their ER stay was like before a 3 month hospitalization six weeks after going home? There are apps available now which allow patients to perform the survey real-time. It would result in more reliable data that providers can act on more quickly which will hopefully improve satisfaction more quickly. CMS does not presently allow this type of technology. One objection is that patients might fear retribution during the hospitalization for negative comments. I submit that this is not a widespread concern and that people would hope that the criticisms would result in positive corrections, and that providers’ ethics would triumph over pride.
  2. Point of service mobile patient education tools. There are many patient education tools out there now. Some are provided as a service by Pharma and medical device companies (which are naturally challenged as a conflict of interest). Others are provided by some excellent third-party commercial entities. However, the uptake of these apps is low. Providers are in general not delivering digital content to patients. The mandate for utilization of patient portals is only for 10% of hospital Medicare patients and 5% of outpatients. In addition, the requirement for exchange of information is extremely vague. The investment in patient education tools will likely result in improved risk management (decreasing law suits), improve patient adherence to medications and instructions, and allow for caregivers to have access to the information.
  3. Video consultations. Venture capitalists are investing in technologies which facilitate medical encounters via smart phones. The market for such interactions has arisen as a natural evolution of the use of mobile technologies in the retail and finance sectors as well as Congressional interest in expanding telehealth services. Lack of adequate access to care (as illustrated in a Merrit Hawkins survey on physician appointment wait times), impact of in-person visits on caregivers, logistical problems for rural patients, and lack of available inexpensive  care after hours are all factors which make this technology attractive.
  4. Remote patient monitoring (RPM) with lay interpretations for patients and caregivers. There is no doubt that remote patient monitoring will play a large role in the healthcare continuum. Its importance will grow significantly because of Medicare penalties now imposed to hospitals because of readmissions (with expanding diagnoses and time intervals from discharge in the near future). Problems with many (though not all) RPM tools today include the lack of interoperability with electronic health records, the lack of analytics utilized to make the data actionable and tied to good clinical decision support tools, and the lack of apps which make it a truly mobile technology. Mobile apps incorporating RPM data need to get to patients and their caregivers as well, in digestible lay terms. Data transformed into simple suggestions for either lifestyle changes, instructions to contact a provider, or medication changes will transform RPM from a passive to active tool.
  5. Utilization in clinical trials. I foresee the use of apps for recruiting, entering real-time data re: symptoms, adverse events (AE), medication verification and adherence log, and secure messaging with study coordinator. This can potentially result in higher participant retention rates, improved safety (re:real-time AE reporting), and increased study center communications.

Though there are many more uses for mobile health technologies which can be utilized right now, I believe that the above can exert substantial impact with respect to creating awareness, adoption, and marketing opportunities. What we need are physician and healthcare administrator champions (who admittedly have much on their plate now), increased awareness of these technologies by the public (caregivers and patients), and expedited regulatory accommodations. It is time for mobile apps to enter healthcare and emerge from the PR shadows of consumer apps.

Posted in clinical trials, FDA, healthcare economics, Healthcare IT, healthcare reform, healthcare vendors, informatics, medical apps, mHealth, mobile health, remote patient monitoring, smartphone apps, telehealth | Tagged , , , , , , , , | 2 Comments

Five Differences between Consumer and Patient Sensor Technologies

The technology industry has been buzzing of late because of the big players entering the wearable sensor market. We are very familiar with Misfit and Fitbit for some time. Others investing into the sector include Intel, Microsoft,  Apple and Samsung. There is no doubt that the inertia for fitness trackers is undergoing modulation. This is a result of both a dampening of the initial ‘wow’ factor by consumers and a maturation of the market. Recalls of Fitbits makes this officially a mainstream product.  As consumer fitness sensors navigate their way in society, one must appreciate the fact that introduction of this kind of technology is paving the way for its future use in mainstream healthcare enterprises. However, there exist significant differences between the consumer and healthcare markets (though I am certainly not denying the fact that a patient is also a consumer).  I have previously discussed issues vital to designing and implementing digital health technologies. I will attempt here to touch on five critical differences between the consumer and patient care markets.

1. There needs to be buy-in by the healthcare provider for patient-facing trackers. There are few physicians these days that roll their eyes when patients tell them they have looked up something related to their complaint or condition on the Internet. Such was not the case 15-20 years ago when online health information was far less reliable.  Today there are websites which are routinely suggested to patients to obtain information, and in fact virtually all physicians and other providers utilize the Internet and apps to obtain information. In order to garner support of providers, the technologies need to: improve efficiency, achieve better patient outcome, and deliver data in either stealth or meaningful ways via utilization of quality analytics within new care delivery processes. This contrasts with the direct to consumer model (see also number 4 below).

2. Consumer-facing trackers need not demonstrate efficacy. There is no burden of proof of efficacy for a consumer item. The sale of the technology is the ultimate goal but adherence is not. It should be noted that the recall of the Fitbit Force was ordered by the Federal Product Safety Commission for an unacceptably high incidence of contact dermatitis (skin irritation) from the device, not because it didn’t perform up to standards.  Hospitals will be places for the critically ill and a place to have procedures performed. This scenario is already a reality in many developed countries. One way to achieve this is with the utilization of reliable proven and unobtrusive technologies. Technologies will be used to monitor patient at home to decrease hospital readmissions, manage chronic disease states, and help people age at home.These technologies will need to prove their worth with outcomes studies. The targeted outcomes might consist of cost efficiency, clinical benefit, or others. Is this too much for patients and providers alike to request?

3. Patient-facing trackers require more than pure data. Lost or ignored data garnered by a consumer fitness tracker has little consequence. What is done with the data in a patient-facing device is the potential of its success. Does it mean the person needs to walk more? Faster? If it suggests bad sleep pattern (a stretch) is it because of obstructive sleep apnea or a noisy neighbor? Does an increased heart rate require the person to drink more fluids, take less insulin, have their blood count or thyroid checked, or increase their diuretic usage?  Therein lays the challenge for companies of these products (or others which process data from different sensors). The product might be the same, but unless analytics and processes for evaluation and management of actionable data (hopefully driven by the user demographics and medical history) are in place, the shift from consumer to patient-focused tech will not be successful.

4. Patient-facing tracking sensors need payer participation. Right now there is no concrete incentive for a consumer to use a heath tracking device.It is already clear that healthcare providers are becoming payers.  In addition, we are also witnessing more payers becoming providers.  Some of the more visible politics of this trend have been seen in the  Highmark versus UPMC battle waged in public media campaigns. Whatever the level of participation, payers are critical to the adoption of these technologies.  The development of new business models is necessary. A wearable sensor has a better chance of being utilized if the patient is incentivized financially vis-a-vis lower healthcare premiums to wear it in the context of an overall treatment program. The data can be used by wellness or chronic disease management coaches already widely used by payers.

5. Consumers are self-managers and patients often depend upon caregivers. While the walking well constitute the majority of consumers of fitness trackers, family caregivers are becoming increasingly more important to the healthcare system. These people also need to be connected to the data derived from sensor trackers of their patients. Most directives arising from algorithmically derived data should be targeted to both the patient and a caregiver to facilitate understanding and adherence. Consumer-facing trackers might focus on trendy language associated with the data, stylish design or graphics. Patient sensor platforms need to deliver understandable and timely simple instructions to them and caregivers.  Caregivers are necessary intermediaries to patients whereby consumers are independent recipients and managers of the data.

There might be some significant differences among financial analysts and others regarding fitness tracking revenue predictions. These predictions often mix the apples of consumers and patients. I believe these technologies will become an integrated part of healthcare. However, the shift from consumer to healthcare markets is not one as simple as some make it sound. It will not be seamless by any means and will require financial, strategic, clinical, and sociological considerations to be incorporated into that transition. I look forward to being both an active participant and observer of this process.


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