By Nancy T. Rector and Hugh Rector
Chief Operations Officer and Chief Executive Officer
Kickstand Business Concepts, Inc.
Decisions….decisions…decisions. Telehealth is all the buzz right now. Plenty of “toys” exist in the marketplace for not only wellness & fitness but also for true medical devices. For right now, we’re going to focus on medical devices for vital sign measurement.
Where do you start? There are many starting points: you may have had a request by your team or you recently read that your facility outcomes could use some improvement and you want to try a tangible process to measure the possibility of real benefits. Wait--but first, what are the state and federal regulations that will affect your reimbursements? Before you consider a pilot, check the following link to familiarize yourself with your state regulations:
A Process, Not a Product
The first important aspect of a telehealth pilot requires that you remember that it is a process, not a product, and that the right team is essential to overall, sustainable success. Then what? You must ascertain what questions need to be asked and answered when setting up the pilot. During this stage, the following should be thoroughly considered and analyzed:
Identify your goals. What do you want to achieve?
A few quick thoughts:
- A process change or quality initiative to measure basic process improvements: after-hours monitoring in a skilled facility or the implementation of a new process for home monitoring for your practice or facility
- A non-scientific study with specific measureable objectives that will be utilized to institute broader change or utilized for facility marketing purposes
- A peer-review study with a scientific protocol for the purpose of publication in a professional journal
Who will participate in the study? Who will be a part of the team? Once you have determined what pilot type is right for your type of facility, it is necessary to develop the team you wish to use. These members will need to be detail-oriented, forward-thinkers. They will need to understand the process and specifically how to develop and execute a process. Without Process and Team there is no success. This team will need to set specific goals and goal time frames; they will need to understand how to put the goals into motion and further how to continue to motivate others to assist in the implementation of the How and What, which is discussed later in this article.
One of the most critical aspects of the process is determining the “where?” and/or the “who?”. Specifically, where is the desired impact and/or what patient population will be utilizing the new process? In coming to this determination, it can be broken down to a specific patient DRG (Diagnosis Related Group), a segment of facility population (e.g., wing, floor, etc.), or any other defined set of patient circumstances. Once you identify this critical aspect, it will guide you in identifying the appropriate process and equipment.
Current Process vs. New Process
Now we revisit the How and What in greater detail. How do you envision changing your current process? Understanding what you want to change and where that change will enter into the current processes is critical to understanding the specific product requirements for accomplishing your identified objectives.
Consider the following examples:
- If your goal is RPM (Remote Patient Monitoring) only, this will impact the system you choose. Specifically, RPM won’t require 2-way HIPAA secure video.
- If you want active patient/clinician interaction, you’ll need a video system, but not necessarily one that is built into an RPM system.
- If your clinician’s process is cardiac-related, the process will typically require specific devices, such as a stethoscope.
After identifying the How and What, you’ll need to identify the specific tools required to achieve your stated objectives. So you must ask yourself: What telehealth tools do I need for the process? You have already assembled your team, analyzed your patient population, and identified your process goals and initiatives.
Your next step? Now you must investigate the various products that you feel would be a possible fit into your program. Sounds easy, right? Sure; until you realize you have no concrete information on the specific product or the company you’re investigating. Enter: FDA registration. During your investigation, FDA registration will come into full view. Why? Because no products utilized in these programs or processes should be utilized without the government’s approval, or without being FDA cleared or registered, unless your program is a “wellness only” program.
As there are different devices utilized to perform an array of tasks, it is important to understand what type of “clearance” will be required. For example, “Class I clearance” is required for devices that will be performing “observation only” functions, while “Class II clearance” is required for devices that will be used to assist with “clinical decisions”, or diagnoses. Each of the foregoing clearances have varying requirements. A quick review of classifications can be found at the two following FDA web links:
By way of illustration, if the product is a “Class I” device/product, it is imperative, or at least to your great advantage, to verify that the product was developed within “Good Manufacturing Practice” or GMP guidelines, a set of standards aimed at ensuring a controlled manufacturing process based on quality and safety.
Once the quality has been assured, you must then determine whether the functionality of the devices will work within the pre-determined parameters of the pilot. “Trial and Error” rules this aspect of the process, I’m afraid. So be sure to choose carefully and attend conferences and tradeshows such as ATA, HIMMS, and the mHealth Symposium, in order to increase your knowledge and to further network with others who are trying to accomplish the same, or similar, goals as your Team has established.
Most manufacturer-based telehealth systems will not have everything you require for your process. Don’t be afraid to use several different companies together. One of our studies in progress utilizes 3 different products for the program that run together seamlessly.
On To Pilot Execution!
Ultimately, the key aspects to success are “Process and Team.” The products you choose will be improved upon quickly by the manufacturers, and new telehealth sensors and software are introduced into the market on a routine basis. As with the weather, those telehealth tools will be ‘ever-changing” with the lightning speed advances in technology. Your success is dependent on your team, your goals, and the identified process.