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.

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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.

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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.

 

 

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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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Point of Engagement Business Models for Digital Health Technology


          One of the biggest challenges globally that patient-facing digital health technologies face is finding ways to gain traction and to generate revenue within traditional reimbursement systems. In a previous post, I discussed best practices for adoption of technology by the healthcare enterprise. But the introduction of technologies is dependent upon other best practices. Many technologies offer tools which address singular technical or clinical issues. They might even prove to produce better outcomes (though precious few have done). Success in the marketplace however, hinges on a combination (some of which are interdependent) of proven results, access to the C-suite door, being attractive to the user (provider and/or patient), and providing a comprehensive approach to a clinical problem. Instead of focusing on how a technology can obtain reimbursement, I submit that a vision of becoming part of a total solution translating to better outcomes will undoubtedly ‘show the money.’ The phrase ‘point of care’ is popular now. I think that the technology version of this is ‘point of engagement’ (POE), where the opportunity for adoption of the tool lies. The POE is dictated by the clinical or workflow need. It might be the office visit, the hospital admission or discharge, or the time at home when the need for such a tool arises.

           Business models which are designed with the POE in mind will find the best chances of success. It is where the shared desire of a patient and provider for a better outcome is greatest. It is where the highest concentration of empathy and resources are found. Combining the concepts of partnering and point of engagement is a recipe for both new care and business models in this sector.

           A cardiac patient at the time of discharge from the hospital might be given an interactive app which has been shown to decrease readmission rates, blood pressure, and weight. The app contains educational content and tracking of vital signs. There might be other apps which are connected wirelessly to vital sign monitors and might also contain specific disease state educational content offerings. The content might originate from pharmaceutical or medical device companies (furnishing instructions about how to optimally use a product within the context of a comprehensive treatment approach), from one of a number of third-party digital health content providers, or the healthcare enterprise itself which might customize and/or brand provided content. Best of breed sensors (a combination of wearable and environmental) might be combined to monitor the patient. Both content and data can then be incorporated in the patient’s EHR or third-party portal.

            Patient portals are themselves POE tools. They are accessed by patients and caregivers at a time when information is needed to be obtained or transmitted.

            At the pharmacy, a patient or caregiver presents to fill a prescription. At the same time, an app describing how that drug is to be used is digitally transmitted by the pharmacist at checkout.

            The patient visits the physician’s office for a follow-up appointment. In the waiting room a tablet is given to the patient to complete a patient satisfaction survey. Virtual glasses are given to the patient through which an educational video is transmitted about the discharge diagnosis. A login might be provided to an online patient support group.

           See the pattern? A specific part of the matrix of the ‘usual technology suspects’ is relevant at different points of engagement. The matrix involves disease state education and management tools (via apps, digital content sent via email or patient portal), social media, the EHR, and peripheral devices (remote monitoring sensors/devices, smartphone, tablets, Internet). The ideal digital health business model involves the partnerships of technologies which are relevant and additive (either in a clinical or operational way). Consideration of the POE is critical for business development of tech tools in healthcare, both from introduction as well as adoption standpoints. A clinician team member or advisor is therefore imperative in the formulation of strategies built around points of engagement. I believe that thinking of this matrix in the context of clinical settings is paramount to success. ‘Build it and they will come’ is possible only with the POE in mind.

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Transforming a Digital Health Technology Tool into a Solution


I always pay attention to the reaction I receive from an audience at a talk or individual I encounter when I discuss the difference between a tool and a solution. Marketing a technology as a solution before it has been trialed, integrated into clinical workflow or even an EHR can even be met with legitimized skepticism by an educated purchaser. I offer a few thoughts on the subject which are critical for the development, adoption, and success of digital health technologies. These have been discussed in various other pieces I have written, but are focused here on the issue of technology as a solution.

1.    Solve a specific problem. The Merriam-Webster dictionary definition of solution is: “Something that is used or done to deal with and end a problem : something that solves a problem.” It might seem obvious that a technology touted as a solution would solve a problem. Addressing specific concerns, whether they are workflow-related, clinical should be the driving force behind a technology. The problem should be one which requires bidirectional input so that metrics can be tracked and evaluated. This will facilitate identifying potential pain points from technical or human perspectives requiring improvement.

2.    Give as much importance to processes as to technology. Technologies do not operate in a vacuum.  Many digital health technologies (if not most) involve staff education, restructuring workflows, and perhaps rethinking human resource requirements. All of these considerations translate into new processes within which the technology will operate. Certainly this has been illustrated in the area of electronic health records. Some processes built around the technology have had both negative impacts (decreased physician/nurse efficiency and time with patients) and positive ones (billing, scheduling, e-prescribing). Given time, both the technology and processes will likely arise to improve upon the negatives. Many of the pain points experienced in the implementation and use of EHRs are borne out of the fact that they were not developed with provider-patient workflow in mind and therefore do not offer a good user experience. This is due to the development addressing needs to satisfy regulatory requirements, not clinical issues. Other technologies will not be strapped with as much regulatory restrictions and have the freedom to create friendly and effective processes. It is up to many of us to demonstrate to physicians that EHRs are not representative of the rest of the digital health technology sector which holds much promise for achieving positive and honorable goals from both the provider and patient perspective.

3.    Demonstrate positive outcomes.  Most digital health technologies need not undergo long clinical randomized trials to demonstrate outcome. However, prospective studies looking at time efficiencies, user satisfaction, and eventually clinical impact are what a purchaser of a technology would not only demand but expect. The development process must include small trials in order to result in quality cost-effective outcomes for the company itself.The best time to collect data is from the beginning of implementation, even if it is a minimal viable product trial. This will be the best way to identify weaknesses and strengths of the product and processes. Until data is collected and the ROI (whether it be clinical, financial, or other type) demonstrated, a technology should not be called a solution. Business impact can be measured on strategic, operational, and tactical levels. According to the excellent book Measuring ROI in Healthcare, effective measures are: important, complete, timely, visible, controllable, cost-effective, interpretable, simple to understand, specific, collectible, team-based, and credible.

4.    Create partnerships (doing whatever it takes) to solve the problem. Sometimes this is the most difficult part of the vision and execution of the project. Budgeting resources, whether they be financial or human is best accomplished by partnering with other entities which can contribute to the solution in ways otherwise not achievable. The partnerships might be in technical, clinical, or business development areas. They sometimes might involve strange business bedfellows. The production of a more robust offering (whether it be from a technical or strategic standpoint) is going to make it easier to get into a C-Suite or perhaps result in better process or clinical outcomes.

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Five Ways Patient Engagement Can Start in the Office


There are over 58 million references to ‘patient engagement’ if one conducts a Google search. The term has been diluted and changed in the past couple of years and has become a buzz phrase, used more from a business than clinical benefit perspective.  The Center for Advancing Health defines patient engagement as “actions individuals must take to obtain the greatest benefit from the healthcare services available to them.” This implies that the engagement is generated by the patients themselves, not received from others or technology which is often implied. Engagement is a process which, as I have stated before, will require a change of the culture of healthcare, morphing the adversarial provider-patient relationship into a shared decision-making one. This process cannot result from the adoption of technology, regardless of how ‘patient-centric’ it might be. In a previous post I discussed how patient empowerment must precede patient engagement.  I think the process is a slow one which can be accomplished.  Patients who do not have smartphones, who have been non-adherent, who are skeptics of physicians all can become engaged. It starts with baby steps which I will offer here and which I participate in every day in my office with patients. There are countless mobile apps which monitor patients’ vital signs, activities, symptoms and thoughts with diary logs. The use of mobile health apps is something I feel is a beneficial and inevitable and important part of the future healthcare landscape. I have spent a considerable part of my time in this arena both as a paid and volunteer consultant. The premise of apps is to make a process more convenient. If patients do not do these things in other ways, the convenience factor is lost.  The app itself becomes a tool which might be less appreciated. In addition, those patients without smartphones (estimated to be 20% of the population over 65 years old in the USA), mobile apps will not be adopted immediately.

1.    Have patients start to monitor their health metrics with pen and paper.   One example in which I as a cardiologist engage patients initially is to have them start to manually keep track of their blood pressures (if a diagnosis of hypertension is suspected but not made, if medications are changed which might affect BP, or to attempt to correlate symptoms with BP). I observe a compliance rate of 100% with a request for a two-week log.  At follow-up (either via the patient portal or in person) I review the record (I supply the patient with a pre-printed chart to fill out), reaffirm the importance of the data, and then perhaps move to discussions about monitoring via simple apps that they or their caregiver might use (even if unrelated to blood pressure).

2.    Introduce mobile health apps for wellness first. When discussing diet, medication adherence (especially when prescribing a new one), disease state education, or perhaps smoking cessation, I make it know that there are apps to assist in those areas. I give a list of the best ones and suggest that their caregiver if needed help with the download or use of the app. I show sample snapshots from the app store on my own phone.  I believe that wellness apps are easier to introduce as engagement tools than specific disease apps (at least to the less digitally literate).

3.    Discuss your philosophy as a physician. After I introduce myself to a new patient (with the same degree of attention to the caregiver in the exam room), I discuss my practice philosophy of only recommending the minimal degree of testing and prescriptions (many patients mistrust physicians as prescribing testing or drugs because of financial incentives).  I then go on to stress shared decision making which requires a partnership of honesty and listening. I believe this to be imperative as it not only sets the tone in a positive manner but establishes the importance of patient participation.

4.    Learn about the patient as a person. Knowing the caregiver support (or lack thereof) around a patient gives a physician the milieu in which shared decision-making is to play out. Critical barriers might exist which will ever prevent success without adjustments by the provider and/or the patient. Caregivers should be involved whether it is a near or distant interested relative, friend, acquaintance or other professional involved with the patient. A patient’s former or present occupation or hobby might impact treatment plans or give insight into educational and levels, and degree of independence.

5.    Create buy-in from physician colleagues. Discussing patient engagement within the context of everyday professional interaction is a great way to change culture one person at a time. In correspondences or conversations regarding a patient, “The patient, family and I have decided”, “I found the BP diary the patient filled out for me very useful” or “I recommended that the patient consider using such and such diabetes app” are non-threatening or proselytizing ways to convey how I view positively and embrace engagement.

While none of these methods are unique or innovative (to utilize some even more overused terms), they work. I truly see, in that first encounter, a reaction of pleasant surprise, time after time. Something must be clicking. Happy trails!

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