Clinical Decision Support (Franklin, TN)

One of the aspects of the invention directed towards the development of a method and system for giving a patient access to an automated process for controlling a specific health issue called a disease. The system handles diseases in a completely automated manner. It utilizes regular dialogues with patients that allow them to collect health status measures, evaluate and assess the progression of their illness and then adjust their treatment to its optimal levels, and give advice to the patient on how to deal with acute flare-ups or episodes. The medical records are updated, the progression of the disease is documented and monitored, as well as the patient’s treatment preferences are stored and then used to provide medical recommendations based on the present situation of the illness. Subjective and objective health measurements can be used to identify the value of a measure, which can be used to adjust patient therapy.

1. Field of the Invention

The present invention generally refers to medical knowledge systems and more specifically to computer-based systems for long-term treatment of diseases in patients.

2. Description of the Related Technology

Our health is the foundation of our lives. Medicine is composed of diagnosis and treatment. The diagnosis is the process of identifying the problem. Treatment is applying the most effective method of treatment. However, not alldiseases are completely curable with the treatment regimen.

Diseases such as asthma and diabetes can require a routine program of treatment, also known as therapy, for the duration of the patient’s life. The illness is treated and not treated in this instance. A patient with diagnosed with a diagnosis could be described as a patient who is managing the disease. It is the process of providing information and monitoring for the patient in order to avoid flare-ups and acute episodes. It also helps to minimize the necessity of costly medical intervention and improve patient wellbeing. The therapyportion of disease management must be custom-tailored to the response of a particular patient since affected patients might respond differently to the same treatment, e.g., a prescribed dosage and pharmaceuticals.

There is a fervent desire to cut costs because managing disease can result in recurring expenses for the society. One must understand the concept of a capitated healthcare system to the most extreme way to understand the reasons why this goal is worth achieving. A fullycapitated system is a system that all will benefit from. If you take it to the extreme, there is no way to get sick, and doctors won’t be paid for never seeing patients since there would be any patients. In a fully capitated system everyone worldwide pays a fixed amount per person per month to health maintenance companies whose sole purpose is to keep you well. Although this is a noble objective but it’s not feasible to achieve. However, a realizable goal is to automatize the process by which the treatment of diseases is done.

The entire concept of managing disease, taken to its extreme, is to visualize the doctor following a patient all day. This isn’t feasible for the majority of people. To reduce costs, thedoctor’s information must be made available to the general population and one approach might be to not need the physical presence of the physician at the site of the patient.

A large portion of medicine is algorithmic. The algorithmic approach to medicine implies that diagnosis is based on a series of steps that isolate the cause. Advanced cardiac life support (ACLS) and advanced trauma life support (ATLS) have shown the extent to which medical care can be improved by setting standards. Some standards may be converted into medical 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. Alexander Graham Bell spilled some acid for the batteries (for the phone’s batteries) on the 1st of March and called for assistance. 7th, 1876. Telemedicine today is an individual-to-individual relationship. The concept of telemedicine rests, in part, on the best practices guidelines that help in making the practice of medicine more as consistent.

The management of diseases is nothing less than the redesign of the practice of medicine. Medicine was primarily a problem of data and the arrangement. Due to the advancement of the personal computer and standards, advances can be made in the field of disease management. The repository of medical data was traditionally managed by doctors. They also had to arrange it so that it could be utilized in clinical practice. All of these functions can now be automated with the help of computer and telecommunication technologies.

The management of disease can include coordinating care for patients across the entire continuum of health care from birth until death. Disease management has a program that is available to all aspects of a person’s life, which includes prevention, diagnosis, treatment and rehabilitation. The process involves managing not only the patient with an illness, but also the healthy person. The majority of providers focus on providing costly and intense treatments to patients suffering from severe episodes of illness. Disease management advocates want to increase the focus on preventive, comprehensive healthcare to improve the overall general health of the population. In a way, disease management attempts to take the practice of medicine from the hands of doctors and put it in the hands of patients.

The majority of “knowledge based” clinical reasoning can be performed better and more reliable by computers. Technology is driving the process of democratizing medicine. It is important to be able to automatize medical procedures, especially for managing disease as well as one that trains and encourages patients to play part in their medical care. A system like this should provide an in-depth, sustainable, and significant competitive advantage in a market for health care that is capitated. The system should be able to automatically identify the most critical elements in any disease process, in order to allow intervention to be clinically, economically, and also humanistically optimized.

In one embodiment there is a computerized method of providing medical advice, the method comprising performing at least one interactive dialog with a patient via a computer so as to elicit current health conditions of the patient, automaticallyassessing the current health conditions of the patient through the interactive dialog with the patient, and providing medical advice based on the health assessment of the patient.

Another type of embodiment offers computerized systems for managing patient data. It includes a computer and an input device which can get information from patients. A output device is connected to the machine in order to provide information to the patients. A health assessment module is operated by the computer system which allows the computer to evaluate the patient’s current health status via an interactive dialog. The output device gives medical advice based on the assessment of health status of the patient.

Another embodiment relates to an automated method of evaluating a patient?s health. This involves collecting health data from the patient via the computer interface and saving it in a medical patient file. The computer interface then outputs the health parameter.

Another example provides an electronic method of managing the patient’s health. This includes obtaining a first parameter from the medical record of a patient, asking questions through an interface on a computer to obtain current health data from the patient, analyzing the data to identify another parameter that will provide health progress data, and finally outputting the data.

Another method is a computer-based method for assessing and managing the health of a patient. It involves taking a record of the patient’s health from a memory and asking questions to assess the health status of the patient. The method also includes answering questions from patients to assess their health.

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What is a software medical device?

The FDA could refer to software functions that include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)” that are software that is integral (embedded inside) a medical device.

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

  • It should be designed for use in diagnosing or treating patients; or
  • It should not be designed to change the structure or function of the body.

So, if your application is designed specifically for healthcare professionals to diagnose and treat patients or used in hospitals to handle patient data and patient information, the FDA is likely to view the programs as medical devices subject to review by regulators.

Is Your Software a Medical Device?

In accordance with FDA’s current approach to oversight that is based on the capabilities of the software higher than the device’s platform, FDA will apply its regulation only to medical devices that have functions that be a risk to patient safety. Some examples of Device Software and Mobile Medical Apps FDA is focusing on

  • Software functions that help patients with diagnosed psychiatric conditions (e.g. the post-traumatic stress disorder (PTSD) anxiety, depression, obsessive-compulsive disorder) maintain their behavioral strategies for coping by providing a “Skill of the Day” behavioral technique or audio messages that the user can access when experiencing increased anxiety;
  • Software functions that provide periodic educational updates, reminders, or motivational advice for smokers who are trying to quit, those recovering from addiction, or pregnancies women;
  • Software functions that use GPS location data to warn asthmatics when they’re close to high-risk areas (substance abusers) or to warn them to environmental conditions that could cause symptoms.
  • Software functions that make use of video and video games to motivate patients to perform their exercises in their own homes;
  • Software functions that require the user to input the drug and herb they’d like to use in conjunction and offer information about the likelihood of interactions being reported in the literature, as well as a summary of what type of interaction was observed;
  • Software functions that utilize factors that affect the health of a patient, like age, gender, and behavioral risk factors to provide specific screenings for each patient, counseling and preventive recommendations from well-known and reputable authorities;
  • Software functions that utilize an inventory of the most common signs and symptoms to provide an overview of health conditions and advise on when to see a health care provider;
  • Software functions that guide a user through a questionnaire of symptoms and signs in order to recommend the kind of health care facility most appropriate to their needs;
  • These mobile applications allow users to make nurse calls, or emergency calls using the internet or cell phone technology.
  • Mobile applications that permit the patient or caregiver to design and send an alarm or general emergency alert to emergency responders.
  • Software that tracks medications and provides user-configured reminders to help improve medication adherence.
  • Software functions that give patients access to their health information. This can include historical trends and comparisons of vital indicators (e.g. body temperature, heart rate, or blood pressure).
  • Software features that combine and show trends in personal health events (e.g. hospitalization rates or alert notification rates);
  • Software tools allow users to electronically or manually enter blood pressure information, share it with e-mail, track it and trend it, and then upload it to an electronic or personal health record.
  • Mobile apps that offer dental health reminders, or monitoring tools for people suffering from gum disease;
  • Apps that give mobile users access to information and tools for prediabetes patients;
  • Apps that allow users to display messages and images on smartphones, which could be utilized by addicts looking to end their addiction.
  • Software functions that provide safety and drug interaction information (side effects and drug interactions, active ingredient active ingredient) in reports based on demographic data (age and gender) as well as current diagnoses (current medications) as well as clinical information (current treatment).
  • Software functions that provide the surgeon with a list of recommended intraocular lens powers and recommended axis of implantation based on information inputted by the surgeon (e.g. an expected surgically-induced astigmatism that is likely to occur, patient’s axial length and corneal astigmatism prior to surgery, etc.)
  • Applications, mostly mobile that converts a mobile platform to a regulated medical device.
  • Software that can be connected to a mobile platform using a sensor or a lead that measures and displays the electrical signals produced by the heart (electrocardiograph, ECG).
  • Software that attaches sensors to the mobile platform, or any other tool within the platform, that allow users to see the eye movements, record and analyze the eye movements to detect balance disorders
  • Software that questions potential donors about their history with donors and records and/or transmits those answers to the blood collection facility. The software will determine the eligibility of a potential donor to receive blood or other components.
  • Software that connects to an existing device type to control the device’s operation, function or power source.
  • Software that changes the functions or settings of an infusion pump
  • Software that regulates the deflation or inflation of the blood pressure cuff
  • Software that can calibrate hearing aids and evaluates sound intensity characteristics and the electroacoustic frequency of 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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