Clinical Decision Support, LLC (Nashville, TN)

A method and system for providing a patient with an automated process for controlling a specific health issue called a disease. The system manages diseases with complete automation that involves regular interactive dialogues with the patient, to gather health state measures from the patient, to assess and evaluate the progress of the patient’s condition, to assess and adjust therapy to appropriate levels and to offer the patient medical advice for administering treatment and handling symptom flare-ups as well as acute episodes of the disease. The medical records are kept up-to-date and the progress of the illness is stored and monitored, and the patient’s treatment preferences are recorded, and later utilized to give medical recommendations based on the present situation of the illness. A prestored general disease trend curve is then compared to a patient specific disease trend curve and the system generates an automatic response, such as adjusting therapy.

1. Field of the Invention

The invention generally is a reference to medical knowledge systems and, more specifically, systems for long-term computerized management of patient diseases.

2. Description of the related Technology

Our health is the base of our lives. Medicine includes diagnosis as well as treatment. Diagnose refers to identifying the cause of the patient’s problem treatment is the application of the most effective therapy available. But, not every disease can be completely cured by an effective treatment plan.

Asthma and diabetes could require a regular regimen of treatment, referred to as therapy, for the duration of the patient’s life. In this case, the disease is managed instead of being cured. Management of disease can be described as the practice of assisting a patient who has a known diagnosis with the aim of providing education to the patient and monitoring in order to avoid flare-ups of symptoms as well as acute episodes of the disease, in order to reduce expensive medical interventions and improve patient well being. The therapeutic portion of the disease management must be custom-tailored to the specific needs of a specific patient as affected patients might respond differently to the same treatment, e.g. the prescribed dose or pharmaceuticals.

Since managing diseases can result in recurring costs to society it is an overwhelming desire to cut expenses. To understand why a capitated healthcare system is so important it is first necessary to look at it in its extreme. A fully-capitated system is one in which everyone will benefit from. If you take it to the extreme, no one will ever be sick, and doctors will not be paid to not see patients. In a fully capitated system everyone around the globe pays a predetermined amount per month per person to health maintenance organizations that’s sole goal is to keep you healthy. This is an admirable goal, but impossible to attain. Automating the treatment of illnesses is a realistic goal.

The whole concept behind health management, taken to the extreme, is to envision a doctor following a patient around for 24 hours a day. This is not feasible for most people. The doctor’s expertise should be available to the public to reduce expenses. One solution is not to require the doctor be present at the site of the patient.

The majority of medical practice is algorithmic. That is, the diagnosis follows a sequence of steps that determine the root of the issue. Standardization has been demonstrated to improve the quality of care for advanced cardiac life support (ACLS) and advanced trauma lifesupport (ATLS). The standards could be used to develop medical algorithms to help doctors set the standard for treatment. The concept of telephone medical advice has been proven by nationwide poison control centers, and physicians,particularly pediatricians, have practiced medicine over the telephone since it was invented. Alexander Graham Bell spilled some acid for the batteries (for the battery of the phone) on the 7th of March and told the audience: “Come here Mr. Watson We’re in need of you.” 7, 1876. Telemedicine today is still an one-to-one relationship. The phenomenon of telemedicine depends partly on best-practice guidelines helping to ensure that the practice of medicine is consistent.

Management of disease is nothing more than the re-design of the procedure of medicine. The medical field was originally a problem of information and its arrangement. Personal computers and standardization have made it possible to make advances in managing diseases. Doctors were in the past the “arranger” of medical data. But these functions can now be performed in an automated way by using the”lever” of telecommunication and computer technologies.

Management of diseases can mean the coordination of care for patients across the entire health care continuum from birth to death. There are programs for every stage of a person’s life, including prevention, diagnosis, treatment, rehabilitation. The process involves managing not just the patient suffering from an illness, but also the healthy person. A lot of times, healthcare providers concentrate on providing intensive and costly services to patients with acute illnesses. Diseasemanagement advocates seek a greater emphasis on preventive and comprehensive healthcare to improve the overall health of all people. Disease management is, in a way an effort to take medical care from the hands of physicians and put it into the patient’s hands.

Almost all “knowledge based” clinical reasoning is able to be performed better and more reliable by computers. Technology will drive the transformation of medicine to a more democratic system. It is essential to be able to automate medical procedures, especially in the management of disease as well as one that trains and empowers patients to play part in their healthcare. Such a system should give an ongoing, substantial and substantial competitive advantage in a capitated healthcare market. Such a system should be able to automatically identify crucial points in any disease process so that interventions are clinically, economically and humanistically enhanced.

In one instance it is possible to implement a computer-generated no response method that includes retrieving a prestored question associated with a medical aspect of a patient, distributing the query to the patient waiting for a predetermined time in accordance with the question for responses from the patient and triggering a time out condition in case the answer is not received within the time period.

A different embodiment is comprised of an automated system for managing disease which responds to a situation in which the patient isn’t able to answer an inquiry. The system also has the no response (NR function) that is, in the case of the no-reply function is a time-out condition where a patient fails to answer a question. A device for output that sends an automated message to the patient or a contact to inform the patient that they didn’t give a response.

In another embodiment, there is a computer-usable medium that includes computer-readable code embedded therein to respond to a physician who is unable to provide a response to an automated medical query or question, the computer-readable code containing instructions for displaying one or more questions to an individual who is a doctor; waiting for a response to the displayed questions, and then executing a continuation step in the event that the response isn’t received.

A different embodiment is comprised of an automated medical system that includes a no-response (NR) function. The system is comprised of an application that interacts with the user through questions and answers to perform the automated assessment of health and treatment. A NR function within a module informs the user, or an agent, if the user does not respond in a timely manner in response to a query.

Another embodiment of the computerized no-reply method includes the following: storing various parameters; selecting an appropriate medical script, waiting for a preset response; performing an action based on the parameters once the preset period has ended with no response.

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What is a software medical device?

The FDA refers to software functions that can comprise ” Software as a Medical Device” (SaMD) as well as “Software in a Medical Device (SiMD) ), which is software that is part of (embedded within) the medical device.

Section 201(h),?21 U.S.C. 321(h),(1) defines medical devices as apparatus, instrument, machine, machine implants, devices, contrivances in vitro regulator or other similar or related articles, as well as a component or accessory. . . (b) intended for use for the diagnosis of illnesses or other conditions or for the treatment, mitigation, treatment, or prevention of disease for animals or humans or (c) intended to affect the structure or functions of the human body or any other animal.? To be considered a medical device, and consequently subject to FDA regulations the software must satisfy the minimum of the following requirements:

  • It must be intended for use to diagnose or treat the patient
  • It is not intended to alter the structure or any function of the body

Thus, if your software is specifically designed for healthcare professionals to diagnose and treat patients, or is used in hospitals for the management of patient records and patient information, the FDA would likely view such programs as medical devices subject to regulatory review.

Is Your Software a Medical Device?

As per FDA’s current oversight strategy, which considers the functionality of the software, rather than the platform, FDA will apply its regulation only to medical devices with functionality that could be a risk to patient safety. Some examples of Device Software and Mobile Medical Apps that FDA is focused on include

  • Software functions that aid patients with diagnosed psychiatric conditions (e.g. the post-traumatic stress disorder (PTSD) anxiety, depression, obsessive compulsive disorder) retain their strategies for coping by providing a “Skill of the day” behavior technique or audio-based messages users may access during times of increased anxiety;
  • Software functions provide periodic reminders, motivational guidance and information on education to patients recovering from addiction, or who are trying to quit;
  • Software functions that use GPS location information to notify asthmatics when they are near high-risk locations (substance abusers), or alert asthmatics to environmental conditions that may trigger symptoms.
  • Software functions that make use of video and video games to entice patients to perform their exercise routines at home;
  • Software functions that ask a user to enter which herb and drug they would like to take concurrently and provide information about the likelihood of interactions being reported in the literature and an overview of the type of interaction was observed;
  • Software functions that utilize patient characteristics such as age, sex and other risk factors for behavior to provide specific screenings for each patient as well as preventive counseling from well-known and reputable authorities;
  • Software functions that use a list of typical symptoms and signs to provide the possibility of medical conditions , as well as advice on when to see an expert in health care;
  • Software functions that guide the user through a checklist of symptoms and signs to give a recommendation on the type of health care facility most appropriate to their needs;
  • Mobile apps that are intended to allow a user to make a pre-determined nurse call or emergency call by using broadband or cell phone technology.
  • Apps that let patients or their caregivers to communicate emergency alerts to first responders using mobile phones
  • Software that monitors medications and gives user-defined reminders to increase medication adherence.
  • Software functions allow patients access to their health information. This includes historical trending as well as comparisons of vital indicators (e.g. body temperature, heart rate or blood pressure).
  • Software functions that display trends in personal healthcare events (e.g. hospitalization rates or alert notification rates)
  • Software functions let users either manually or electronically enter blood pressure data, to send it to e-mail, track it and trend it, then upload it into an electronic health record.
  • Mobile apps that offer reminders about oral health or tracking tools for those suffering from gum disease;
  • Apps that give mobile users access to information and tools for prediabetes patients;
  • Mobile applications that display at the right time images or other messages for an addict who is trying to end their addiction;
  • Software functions that offer drug-drug interactions and relevant information about safety (side effects and interactions with drugs and active ingredient) in a form of a report, based on demographic data (age and gender), clinical information (current diagnosis) and the current medication; and
  • Software functions that permit the surgeon to identify the optimal intraocular lens strength for the patient and the direction of the implantation. The data is dependent on the inputs of the surgeon (e.g. anticipated surgically induced astigmatism and length of the patient’s axial axis, preoperative cornea astigmatism, etc.).
  • Mobile apps, usually software that transforms mobile platforms into an approved medical device.
  • Software that communicates with an mobile platform using the use of a lead or sensor to monitor and display electrical signals coming from the heart (electrocardiograph; ECG).
  • Software that connects sensors or other devices to the mobile device in order to observe eye movements to detect balance disorders
  • Software that inquires about their donor history and records and/or transmits those answers to a blood collection facility. The software will determine if a donor is eligible to receive blood or other components.
  • Software that connects with an existing device to control its operation, function or energy source.
  • Software that alters the functions or settings of an infusion pump.
  • Software that controls the inflation or deflation of the blood pressure cuff
  • Software that calibrates hearing aids and analyzes the sound characteristics and electroacoustic frequency of master hearing aids, and group hearing aids.

What does it mean if your software/SaaS is classified as a medical device?

SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.

So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.

Software As Medical Device Patenting Considerations

The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.

Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.

In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.

The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.

When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.

An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.

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