Monday, April 13, 2015

The Decentralization of Healthcare to “Everything to Everyone” or E2E

By Nancy T. Rector

Chief Operations Officer

and Hugh Rector

Chief Executive Officer
Kickstand Business Concepts, Inc.

The process of addressing acute care has been in a continual state of evolution and outward motion since the 1980’s. Today we are experiencing a hyper-decentralization phase that promises to improve not only healthcare, but to also improve our lives in many ways. One improvement in particular is the move from an acute patient care patient focus to complete preventive personal health and wellness. How did this outward process begin and where will it take us? Though this is a global movement, the following is a high-level look at the US in particular.


Necessity is the Mother of Invention

And so is revenue generation. Diagnosis Related Groups (DRG’s)  the Clinical Laboratory Improvement Amendment (CLIA) and the Stark Amendment fueled our team’s involvement in the laboratory decentralization processes as Clinical Concepts in the 1980’s and 1990’s. We assisted in the migrating of laboratory testing out of the main lab and into physician offices and clinics in order to provide a more timely result, closer to both the doctor and the patient, and to also increase revenues. The inception of the first phase began with smaller replicas of the larger lab instruments. As technology became smaller and more portable, the trend evolved into point-of-care testing with hand-held equipment and simplified lateral-flow membrane kit testing at the bedside in Emergency Rooms, clinics, and Physician Office Laboratories.

Outpatient Centers

The laboratory was not alone. In the late 1980’s IV therapy moved out of the hospital and into the home, initiating the startup of the home infusion therapy business. By bringing treatments into the home, this move made care more accessible and convenient for the compromised patient. At the same time, to simplify and streamline care access, Ambulatory Infusion Centers and Outpatient Surgery Centers, along with Renal Dialysis Centers, began popping up in locations further away from the main hospital institution.


The telephone telehealth system began its entrance into homes in the early 2000’s, allowing for the utilization of a telephone key pad to answer questions about an individual patient’s health and progress. Subsequently, circa 2010, was the advent of the “hard line” video and tethered sensors and system based software for remote patient monitoring. The latter was a beginning, but proved to be too expensive and cumbersome to capture wide-spread utilization.

Rocket Launch into the Home

In the last 5 years, wireless technology, cloud based software, and computing mobility designs  have provided the technological foundation for today’s plethora of smart phones, handy gadgets, and wireless sensors with data accessibility to clinicians, fitness enthusiasts, and the enthusiast hopeful, alike. The wide range of FDA registered or cleared wireless sensors includes 1 to 12 lead ECG’s, pulse oximeters, blood pressure cuffs, HD cameras for wound assessment, stethoscopes, glucometers, modules that provide a one lead ECG, respiration, heart rate, body position, caloric burn, and body temperature.  Additionally, there are also the physician-controlled robots, the Apple Watch, Google Glasses, and home monitoring systems that observe movement from one room to the next for Independent Living communities, and even smart TV’s that allow easy and convenient patient/consumer access. As a result, state by state regulatory changes that would provide reimbursement for revenue generation models are currently in progress, thus completing the move forward.

In fact, home renal dialysis units are even available today. I’m not holding out for “Home Surgery”, but never say never! With technology at the helm, there are waters that remain uncharted, and thus the possibilities are endless.

The Forces Behind the Process

Increases in regulatory control, coming from the FDA, HIPAA and the FCC, which required higher spending in medical device product development quickly inflated the product costs, while a steep reduction in cost reimbursement squeezed the financials of both the healthcare professionals and the institutions, thereby widening the chasm between sustainability and development. As a result, revenue generating centers became cost centers and large institutions were forced to take a new look at evaluating services. In order to justify higher priced laboratory products, some medical centers created “risk shares” with the laboratory through the tracking and measurement of specific outcomes to justify higher priced laboratory products. The better the outcome, the more dollars funneled back to the lab. As regulations tightened insurance provider processes, personal/employer increases in healthcare costs have escalated exponentially over the years, fueling the rise in the “wellness focus” with preventative care and personal fitness at the epicenter.  Add federal readmission fines to the already unbalanced mix, and the necessity of invention to find a stable equilibrium is substantially accelerated.

Almost simultaneously, society as a whole has largely taken interest in the individual health and wellbeing of its citizens, and is thus pressing the agenda for an overall improvement to general health. Consequently, the most motivated and relevant population and business segments have become vital driving forces behind the overall shift in focus.

Segments of Care

The generalized care population is divided into two primary segments: Rural and Urban. Within these two segments are three distinct subsets: controlled or “home based”, uncontrolled or “homeless”, and institutional organizations (state and local penitentiaries). Regional Medical Centers, Skilled Nursing Facilities (SNF), Home Health Agencies, and Federally Qualified Healthcare Center’s (FQHC) are currently juggling acute care populations from all three subsets, continually circulating the patients between various healthcare institutions and systems. At the same time, employers handle primarily the “home based” subset, driving employees into and between specific healthcare institutions, as required by the designated insurance provider. Consequently, the need to enhance savings in cost, time, and energy became critical, outweighing the initial emphasis on the patient, and thereby substantially shifting the paradigm to the necessity to move the health “care” instead of the patient. Such a dramatic paradigm shift was the inception of an unsteady healthcare prototype in dire need of equilibrium.

Telehealth vs. Telemedicine

Enter telehealth. Or is it telemedicine? When KBC works with clients we differentiate between the two, and define them upfront:
  • Telemedicine is the communication of Clinician to Clinician via a device that allows for the transfer of patient data/information and enables interactive conversation for consultations and patient therapy access enhancement. Telemedicine systems are typically costly and purchased by large institutions, housed almost exclusively within the walls of the institution.
  • Telehealth is the communication of Clinician to Patient via a device or devices that provides the real time transfer of patient data/information, data cloud viewing for trends, and interactive conversation for more accurate diagnosis and monitoring. Telehealth systems typically reside outside of the medical center or hospital institution, within the continuum of care: SNF, Home Health Agency, and within an individual patient’s home. These systems are less expensive and provide greater flexibility to fit the needs of both the patient and the clinician in the changing healthcare environment.

Telemedicine increases patient access to specialized clinicians in urban facilities, by “store and forward” processes and live video. Telehealth increases clinician-to-patient access and enhances the ability of clinicians to reach patients in their home and in facilities outside of the acute care arena. The long-ago-established, traditional doctor’s “house call” is back, new and improved, with many physician companies now implementing “concierge” programs that provide for primary care via telephone and video (HIPAA secure?). Sensors, video systems, and tablets/smart phones are abundantly available, providing the constant reminder that telehealth is a process not a product.


Today, a plethora of tools abound, with new ones being developed and launched on a continuous basis. Each tool is a part of a process, targeted to a specific result.  However, one size does not fit all; not all process are the same, and one tool does not fit all processes. Not yet… Nevertheless, KBC does utilize “point of care” laboratory testing, as a specific telehealth tool, in order to further enhance and amplify the process, providing additional patient data and outreach. The primary tool segments utilized are delineated below.

  • Point of Care Testing – handheld systems providing bedside blood analysis
  • Remote Patient Monitoring utilizing real time sensors:
    • Regulated: FDA listed as Class 1 or FDA cleared with a 510K submission as Class II (real-time decision making data fully tested);
    • Non-regulated: Fitness sensors
  • Two-way video – HIPAA secure video with banking industry comparable processes and a history of dependability, reliability, and consistency in transmission
  • Cloud-based patient data for clinician viewing or personal use
  • Mobile applications for tablets/smart phones to facilitate “anytime, anywhere” access by both clinician and patient
The Future: Decentralization of Everything…
The March 2015 Frost & Sullivan Executive Mind Exchange, "Embracing a New Healthcare Future," engaged many innovative discussions among thought leaders in the field. One discussion entertained what healthcare would be like in five years and beyond. The participants came up with some highly-developed conclusions including: mobile phones would be a thing of the past; two- way communication/monitoring would be intricately woven into all integral aspects of the nuclear environment – the home and office (if there are any left) and apparel (i.e., glasses, contact lenses, watches, etc.); acute healthcare access would be consumer-driven, beginning at the local Walgreen's, CVS, Rite-Aid, etc. The theories are certainly thought provoking, though somewhat mind-boggling. More importantly, these theories demonstrate well thought out responses to the way in which technology is shaping society and ultimately, the way the healthcare landscape is evolving. These possibilities are within reasonable comprehension, not far from reality, and fully within our capabilities.

“Big data” will be an impetus for the design of the “interoperability” necessary for the “big picture” frame. A good friend and colleague, Dan Martens, CEO of Misix, Inc., stated it succinctly: “Last week I attended a session about Driverless Vehicles. The session made me think about how we will be connected to everything around us. I did some checking on the most recent stats about connected devices. Cisco predicts that by 2020 there will be 50 billion connected devices. A book that I am reading also states the same stat. A decade later, early predictions are one trillion. Whether it is 50 billion or 1 trillion; we are moving to an Everything to Everyone, or E2E  world. As technology changes accelerate, so will our lives. It is hard for me to imagine how my life will be in 2030, let alone when the new Apple Watch is released.”

Nancy Rector Chief Operations Officer of Kickstand Business Concepts, Inc., is a Clinical Microbiologist with over 15 years experience in global marketing, portfolio management, product development and customer service.


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