First Opinion Corporation (La Jolla, CA)
1. Field of the Invention
The invention generally is related to medical knowledge systems and, specifically, systems for long-term computerized management of diseases in patients.
2. Description of the Technology Technology
Health is the base on the basis of our lives. Medicine is composed of treatment and diagnosis. The diagnosis is the process of determining the root of the patient’s issue; treating is the application of the best therapy available. However, not alldiseases are completely curable with an effective treatment plan.
Asthma and diabetes can require a consistent schedule of treatment, termed therapy, for the duration of a patient’s life. The disease is managed, not cured in this case. Disease management may be defined as managing apatient with diagnosed in the hope of providing patient education and monitoring in order to prevent flare-ups of symptoms and acute episodes of disease, in order to reduce expensive medical interventions and improve patient well being. The therapyportion of disease management must be custom-tailored to the specific needs of a particular patient , as affected patients might respond differently to the same treatment, e.g., a prescribed dosage and medications.
Because managing disease causes recurring expenses to society and the public, there is a huge desire to lower the cost. It is important to understand the concept of a capitated healthcare system to the most extreme way to understand why the goal is worth reaching. Advocates of a fullycapitated system believe that everyone benefits. If it is taken to its maximum, no one will ever get sick, and doctors won’t get paid for not treating patients. The concept of a fully capitated system is that every person on the world pays a fixed monthly amount to health maintenance organizations whose sole aim is to maintain your health. While this is a noble goal, it is not feasible to attain. Automating the treatment of illnesses is a realistic objective.
The entire idea behind disease management, carried to its extreme, is to imagine a doctor following a patient all day. Of course, this is an unobtainable solution for the vast majority of people. To cut costs, the doctor’s knowledge should be communicated to the public at large. an alternative is to not require an actual presence by the doctor on the premises of the patient.
The majority of medical practice is the use of algorithms. The diagnosis follows a set of steps that determine the cause of the problem. Standardization has been demonstrated to improve care in advanced cardiac life support (ACLS) and advanced trauma life support (ATLS). Some standards may be translated into medicinal algorithms that can be used to 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 from the battery (for the batteries of the phone) on March 7th and rang for assistance. 7th, 1876. Telemedicine today is still a one-to-1 relationship. Telemedicine is a phenomenon that is based on the best practices of medicine to ensure that medicine practices are consistent.
The management of diseases is nothing less than the re-design of the procedure of medicine. Medicine was initially a matter of data and the arrangement. Personal computers and standardization has made it possible to make advances in disease management. The past was when doctors have been the primary repository for medical information , and also they were the ones who “arrange” it so that it had clinical meaning. These functions can now all be automated with the help of telecommunications and computer technology.
The management of disease can include coordinating care for patients across the entire health care continuum from birth to death. Disease management has a program accessible to every stage of everyone’s life, including the prevention, diagnosis, and treatment as well as rehabilitation. This includes taking care of not only those suffering from the specific illness, but also healthy patients. Too often, providers focuses on providing costly and intense treatment to patients who are experiencing severe episodes of illness. Disease management advocates want to increase the concentration on preventive, holistic healthcare to improve the overall health of the entire population. In a way, disease management attempts to take the medical practice out of the hands of physicians and puts it into thehands of patients.
Computers could perform almost all of the “knowledge-based” medical reasoning more effectively and more reliable. The accessibility and democratization of medicine will be driven by technology. A system that automates the process of practicing medicine, particularly in the field of disease management, and which helps patients and encourages them to play a major beneficial role in their medical care is highly desired. Such a system should give an ongoing, significant, and significant competitive advantage in the health care market that is capitated. A system like this should be able to detect the most critical elements in any disease process so that treatment can be clinically, economically and humanistically enhanced.
In one embodiment of the invention described hereinafter, there is a computerized method of managing diseases, comprising assessing the health of a patient suffering from a condition; and optimizing a disease therapy in accordance with the health assessment of the patient.
A computerized method for assessing correlation is an additional example of the invention. It involves giving a subjective assessment of health from electronic medical records corresponding to the patient, providing an objective measurement of health within the electronic medical records, and then calculating a metric using the subjective measure and the measurement objective.
A different embodiment of the invention comprises the use of a computer-based critical curve assessment method. This involves providing the critical path of an individual disease; providing a range of health parameters in medical records electronically that are corresponding to a patient suffering from the disease in question; and comparing at most one of these health indicators to the critical circle to obtain health assessment information.
A system for managing diseases is another example of the invention. It includes: a disease module which automatically gives health and therapy information for patients with a disease; and permission information that identifies the degree of access permitted to assessments of health and information about treatment.
In a different version of the invention, there’s an electronic medical advice system that includes medical advice modules capable of providing medical advice to a patient; and the permission level for the medical advicemodule.
Another version of this invention offers a computerized method of therapy optimization. This includes determining whether objective health measures and subjective health measurements are available for a patient suffering from a specific disease and adjusting therapy based upon available measures or adjusting therapy according to subjective health measurement that is not available.
In yet another embodiment of the present invention, there is a computerized question version method, comprising offering a number of sets of questions that provide an indication of the patient’s health, each group being related to a level of understanding in a particular language; identifying the linguistic understanding level of a particular patient; selecting one of the groups based upon the identified linguistic level; and asking the patient from the selected group.
In a further embodiment of the invention described hereinafter, there is a computerized method for diagnosing medical conditions which involves: transcoding a patient’s subjective perception of pain into a pain code and then indexing a database of diseases using the pain code, thereby diagnosing a disease.
In yet another embodiment of the present invention there is a computerized therapeutic alterations method, comprising: providing a therapeutic alterations permission level corresponding to a particular patient having a particular disease;automatically determining a therapy adjustment for the patient; and recommending the therapy adjustment to the patient as allowed by the therapy alterations permission level.
In yet another version of the invention is a method for computerized preview mode, comprising: creating a preview mode for medical scripts and asking a question relating to the health of the patient; allowing the patient to receiveinformation relating to the consequences of answering the question; and resetting the medical script in the same manner as in the event that the question has not been answered.
Another version of the invention includes an automated no-response technique. This involves providing a variety of variables and asking a question from an medical script, then waiting for a preset response time, and then making an appropriate action based on the parameters.
Another version of the invention comprises an assessment of health using computers. This involves removing any symptoms that indicate the presence of a specific health condition, then taking initial health measurements from patients even if they haven’t previously been assessed, and then obtaining and storing subsequent measurements from the patient, if they have been previously assessed.
The final version of this invention includes an automated significant symptoms filtering process. This involves: determining severity of significant symptom from patient with a specific disease and assessing the health of the patient to determine if the severity is adequate; and taking predetermined action if severity is sufficiently high.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA may refer to software functions that include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)”, which is a software function that is integral to (embedded within) a medical device.
Section 201(h),?21 U.S.C. 321(h),(1) defines the term “medical device” as apparatus, instrument machines, machines implant, device, or contrivance in vitro-reagent, or any other similar or related articles, including a component, which includes. . . (b) designed for use in the diagnosis of diseases or other conditions, or in the cure or mitigation of disease, or prevention of disease in animals or man, or (c) intended to affect the structure or function of the human body or other animals.? To be considered a medical device, and consequently subject to FDA regulation, the software must meet the minimum of the following requirements:
- It should be intended for use in diagnosing or treating an individual patient.
- It is not intended to change the structure or function of the body.
If your software is designed to be utilized by healthcare professionals to diagnose, treat or manage patient records in hospitals or other healthcare facilities, the FDA is likely to consider the software as medical devices and subject to review under the regulations.
Is Your Software a Medical Device?
The FDA’s oversight currently, which looks at functionality more than platform it is designed to ensure that FDA regulates to only devices for medical use that have capabilities that pose risks to the safety of patients. Some examples of Device Software and Mobile Medical Apps that FDA is looking at includes
- Software functions that help those suffering from psychiatric disorders diagnosed (e.g. the post-traumatic stress disorder (PTSD), anxiety, depression, or obsessive compulsive disorder) maintain their behavioral strategies for coping by providing an “Skill of the Day” method of behavior or audio-based messages users can access when experiencing increased anxiety;
- Software functions that offer periodic education information, reminders or motivational advice for smokers who are seeking to quit, addicts who are recovering from addiction and pregnant women;
- Software functions that utilize GPS location data to alert asthmatics when they’re near areas of high risk (substance users) or to warn them to environmental conditions that may trigger symptoms.
- Software that uses video and games to encourage patients to exercise at home.
- Software functions that prompt the user to input the herb or drug they’d like to use concurrently and provide information about the likelihood of interactions being reported in the literature and a summary of what type of interaction was observed;
- Software functions that are able to take into consideration the characteristics of the patient, like gender age, gender, as well as risk factors, to provide specific counseling, screening and prevention advice from well-established and well-respected experts.
- Software functions that utilize an inventory of typical symptoms and signs to give guidance on when it is appropriate to visit an ophthalmologist and what next.
- Software functions guide a user through a questionnaire of signs and symptoms in order to offer a recommendation on the kind of healthcare facility most suited for their needs.
- These mobile apps allow users to make pre-specified nurse calls, or emergency calls using technology like cell phones or broadband.
- Apps that let caregivers or patients to send emergency notifications to first responders via mobile phones
- Software that tracks medication and offers user-configured reminders to help improve the medication adherence.
- Software functions that give patients with a way to access their personal health records for example, access to data gathered at a previous visit to the doctor or historical trends and comparison of vital sign (e.g. body temperature and heart rate, blood pressure or respiration rate);
- Software functions that show patterns in personal health incidents (e.g. rate of hospitalization or alert notification rate)
- Software functions allow users to electronically or manually input blood pressure data, share it with e-mail or track it, and then trend it, and then upload it into an electronic or personal health record.
- Mobile apps that provide oral health reminders or tracking tools for users with gum disease.
- Apps that give mobile users access to information and other tools for patients with prediabetes;
- Mobile apps that display at the right time images or other messages to a substance abuser who wants to stop addictive behavior;
- Software functions that provide drug-drug interactions as well as pertinent information about safety (side effects, drug interactions, active ingredient) as a report based on demographic data (age gender, age) as well as medical information (current diagnosis) and the current medication; and
- Software functions that permit the surgeon to identify the optimal intraocular lens strength for the patient as well as the optimum axis of implant based on the information supplied by him (e.g. the expected astigmatism caused by surgery, patient’s axial length, preoperative corneal astigmatism , etc.).
- Applications, mostly mobile which convert an app on a mobile device into a regulated medical device.
- Software that can be connected to a mobile device using a sensor or a lead that measures and displays the electrical signals generated by the heart (electrocardiograph, ECG).
- Software that connects sensors or other devices to the mobile platform in order to monitor the eye’s movement to detect balance problems
- Software that gathers data about potential donors and sends it to a blood collection facility. The software can determine the eligibility of a potential donor to receive blood or other components.
- Software that is connected to an existing device to control its operation, function or energy source.
- Software that modifies or disables the functions of an infusion pump.
- Software that regulates the deflation or inflation of the blood pressure cuff
- Software that is used to calibrate hearing devices and evaluate the electroacoustic frequency, audio intensity characteristics, as well as coming from 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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