Clinical Decision Support, LLC (Nashville, TN)

A system and method of providing a patient with an automated procedure for dealing with a particular health issue called a disease. The system manages diseases in a fully automated manner, using periodic interactive dialogs with the patient to obtain health state measures from the patient, to evaluate and assess the progress of the illness, to evaluate and adjust therapy to appropriate levels and to offer the patient medical advice in treating symptoms and preventing flare-ups as well as acute episodes of the disease. Medical records of patients are kept up to date as well as the progression of the disease tracked and stored as well as the patient’s treatment preferences are utilized to provide medical advice according to the current disease status. The system compares a stored general trend curve of disease to the individual patient’s disease curve and provides an automatic response, like changing the treatment.

1. Field of the Invention

The invention typically refers to systems for medical knowledge, and, more specifically, systems for long-term management by computers of patient diseases.

2. Description of the Related Technology

Health is the base on which we live our lives. Medicine comprises diagnosis and treatment. Diagnose refers to identifying the root of the patient’s problem treatment is the application of the most effective therapy available. But, not every disease are completely curable with an effective treatment plan.

In the remainder of one’s life an intervention plan, called therapy, is often required for conditions such as asthma and diabetes. In this scenario the illness is controlled instead of being cured. Patients with an established diagnosis could be described as a patient who is managing the disease. It is the process of providing information and monitoring for the patient to avoid flare-ups or acute episodes. It can also help decrease the need for costly medical intervention and improve patient health. The treatment portion of treatment must be tailored to the response of a specific patient as the patients with a disease may react differently to treatment e.g., a prescribed dosage and pharmaceuticals.

Because managing disease causes recurring expenses to society and the public, there is a huge desire to lower the cost. To understand why a capitated system of healthcare is so important one has to first look at it from a different angle. People who advocate for a fullycapitated system say that everyone wins. Taken to the extreme nobody will ever be sick, and doctors will be compensated for not seeing patients as there won’t have any patients. A fully capitated system is that everyone on this world pays a fixed monthly amount to health maintenance organizations whose sole goal is to maintain your health. Although this is a noble but impossible to achieve. Automating the treatment of illnesses is a viable target.

The whole idea behind health management, taken to the extreme, is to imagine doctors following patients all day. Of course it is not a feasible solution for the vast majority of the population. The doctor’s expertise must be accessible to the general public, in order to decrease costs. One option is to not require that the doctor is present at the place where the patient is taken care of.

A large portion of medicine is algorithmic. The diagnosis is made by a series of steps to determine the source of the problem. Advanced cardiac life support (ACLS) and advanced trauma life support (ATLS) have proven how healthcare can be improved through setting standards. Some standards may be translated into medicinal algorithms, which could help set the standard of care for physicians. 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. In fact, the very first words spoken over the telephone were an appeal for help because Alexander Graham Bell had just spilled acid from the battery (for the batteries for the phone) and said, “Come here, Mr. Watson, I need you” on the 7th of March. 7, 1876. Telemedicine is today an one-to-one relationship. Telemedicine is a phenomenon that relies in large part on best-practice guidelines helping to ensure that the practice of medicine is in a consistent manner.

Disease management is nothing less than the re-design of the practice of medicine. The issue with medicine was mostly an issue of information and the arrangement of the information. The personal computer and standardization have made possible to make advances in managing diseases. In the past, doctors have been the main repository for medical data, and also the ones to “arrange” it to ensure that it was clinically relevant. But these functions are now performed in an automated way making use of the”lever” of telecommunications and computer technologies.

Disease management can involve managing care for patients throughout the entire health care continuum from birth until death. There is a program that covers every phase of a person’s life, including prevention and diagnosis, as well as treatment and rehabilitation. This involves managing not just the person suffering from an illness however, also the healthy person. The majority of providers focus on providing costly and intense treatments to patients suffering from acute illnesses. To enhance the health and well-being of the entire population, diseasemanagement advocates advocate for greater focus on comprehensive, preventive health care. In a sense, management attempts to take the practice of medicine from the hands of physicians and put it in the hands of patients.

Almost all “knowledge that is based” clinical reasoning can be improved and with greater reliable by computers. Technology will drive the transformation of medicine to a more democratic system. A system that automates the practice of medicine especially in disease-management and helps patients and encourages them to play an important role in their medical health treatment is highly sought-after. A system like this should provide an ongoing, substantial and significant competitive advantage in a capitated health caremarketplace. The system must be able to automatically identify critical points in any process of disease, to ensure that treatment can be economically, clinically and humanistically maximized.

One example of an automated method of medical treatment for a patient includes an option to use question versions. This process includes retrieving one or more questions versions that are related to a medical condition for a patient, computing an index of query versions (QVI) for the user, selecting one of the questions from the available version versions; storing that QVI in a storage device and then delivering the chosen version to the user to communicate at a desired level.

Another example is an automated medical treatment system, which includes a DMM (disease management module) to automatically assess a patient’s health and moderating therapy. Question versions are used in data communication with DMM as well as a QVI index (QVI), where the QVI may be used to select a specific version of the same question from the various versions provided by the function of question variations.

Another variant includes an index of question versions for disease management that contains a set of question variants and at least one default question. An index of question versions (QVI), which allows users to choose the correct question version based on their sensitivity, linguistic selectiveness or education level is also available.

Another version comprises a computer-readable program code that is able to obtain and monitor the patient’s information regarding a disease. The computer-readable program code also has instructions for saving a set of questions and choosing a variant of a question from the set based on the QVI (question version index). The information is determined using information about the user of the program.

In another embodiment, there is a computerized question version method, comprising storing a plurality of groups of questions indicative of assessing a patient’s health, each group being related to a linguistic level of understanding;identifying the linguistic level of understanding of a particular patient; selecting one of the question groups based on the identified linguistic level; and asking a question of the patient from the selected group.

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What is a software medical device?

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

Section 201(h) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, instrument such as a machine, device, contrivance, implant, in vitro-reagent or other related or similar articles that include a component or accessory. . . (b) is intended to diagnose or treat disease or other conditions in humans or animals. (c) It is intended to alter the structure or function of animals or human bodies. To qualify as medical devices and therefore subject to FDA regulations the software must meet the minimum of these requirements:

  • It is essential to use it in the diagnosis and treatment of patients.
  • It is to be designed to modify the structure or any function of the body

If your program is intended to be utilized by healthcare professionals to diagnose, manage, or treat patient information in hospitals, the FDA will likely consider such software as medical devices subject to regulatory review.

Is Your Software a Medical Device?

As per FDA’s current oversight approach which evaluates the capabilities of the software higher than its platform, FDA will apply its supervision only to devices for medical use that possess functions that cause harm to patient safety. Examples of Device Software and Mobile Medical Apps that FDA is looking at include

  • Software functions that aid patients suffering from diagnosed psychiatric illnesses (e.g., post-traumatic stress disorder (PTSD) depression, anxiety, or obsessive compulsive disorder) keep their behavioral coping skills by providing an “Skill of the Day” method of behavior or audio-based messages users can use when they are experiencing an increase in anxiety;
  • Software functions that offer periodic education information, reminders or motivational tips to smokers trying to quit, who are recovering from addiction and pregnant women;
  • Software functions that utilize GPS location information to notify asthmatics of conditions in the environment that may cause asthma symptoms or alert an addiction patient (substance users) in proximity to a specified high-risk area;
  • Software that utilizes games and videos to motivate patients to take part in exercise at home.
  • Software functions that ask a user to enter the herb or drug they wish to take in conjunction and offer information about whether interactions have been observed in the literature, as well as an overview of the type of interaction was described;
  • Software functions that utilize factors that affect the health of a patient, like age, gender and other risk factors for behavior to provide patient-specific screening, counseling and preventive advice from well-known and established authorities;
  • Software functions that utilize an inventory of the most common signs and symptoms to provide an overview of medical conditions , as well as advice on when to see an expert in health care;
  • Software functions that guide a user through a questionnaire of symptoms and signs to recommend the kind of healthcare facility most suited to their requirements;
  • Mobile apps that are intended to allow a user to make a pre-specified nurse or emergency call using broadband or mobile phone technology.
  • Apps that let patients or their caregivers to send emergency alerts to first responders through mobile phones
  • Software that tracks medications and allows users to set reminders that can be customized by the user to help improve adherence to medication.
  • Software functions that provide patients with access to their personal health records including access to data gathered at a previous visit to the doctor or historical trends, and comparison of vital sign (e.g. body temperature or blood pressure, heart rate, or respiratory rate);
  • Software features that combine and show trends in personal health incidents (e.g. hospitalization rates or alert notifications rates);
  • Software features permit users to electronically or manually enter blood pressure data, and to share it via e-mail or track it, and then trend it, and upload it to your personal or electronic health record.
  • Mobile apps that allow for tracking and reminders of oral health. They also provide tools to track users suffering from gum disease.
  • Mobile apps provide prediabetes patients with guidance or tools to assist them develop better eating habits or increase their physical exercise;
  • Applications that permit users to display images and other messages on smartphones, which are a great option for substance abusers who want to quit addictive behaviors.
  • Software functions that give information about safety and interactions with drugs (side effects and interactions between drugs, active ingredient active ingredient) in a report based upon demographic data (age and gender), current diagnosis (current medications) and clinical data (current treatments).
  • Software functions give the surgeon an inventory of intraocular lens powers and recommended an axis for implantation based upon the information provided by the surgeon (e.g. an predicted surgically induced astigmatism patient’s axial length , preoperative corneal astigmatism, etc.)
  • Software, typically mobile apps that converts a mobile platform to a regulated medical device.
  • Software that is connected to a mobile device with a sensor or lead to measure and display the electrical signals produced by the heart (electrocardiograph, ECG).
  • Software that connects a sensor or other device to the mobile device to observe and record eye movements to diagnose balance disorders
  • Software that gathers information about potential donors, and then transmits the information to a blood collection facility. This software determines the eligibility of a potential donor to donate blood or other components.
  • Software that is connected to an existing device type in order to regulate the device’s operation, function or power source.
  • Software that modifies or disables the functions of an infusion pump.
  • Software that regulates inflation or deflation of the blood pressure cuff
  • Software that is used to calibrate hearing devices and assess the electroacoustic frequencyand sound intensity characteristics, and sound quality of hearing aids, master hearing aids, group hearing aids or group auditory trainers.

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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