Clinical Decision Support, LLC (Nashville, TN)
1. Field of the Invention
The invention usually is a reference to medical knowledge systems and, more specifically, systems for long-term computerized care of patients with diseases.
2. Description of the Technology Technology
Health is the basis of our lives. Medicine is comprised of diagnosis and treatment. The diagnosis is the process of determining the root of the patient’s issue treatment is the application of the most effective treatment available. A treatment program may not be able of curing all illnesses.
Asthma and diabetes can require a regular regimen of treatment, referred to as therapy, over the course of a patient’s existence. The illness is treated, not cured in this particular instance. A patient who has a diagnosed diagnosis may be described as having a disease management. It is the practice of providing education and monitoring for the patient to prevent flare-ups or acute episodes. It also helps to decrease the need for costly medical intervention and improve patient wellbeing. The therapyportion of disease management should be customized to the response of a specific patient, as diseased patients may respond differently to the same treatment, e.g., a prescribed dosage or drugs.
There is a strong desire to lower costs, since managing diseases is a source of ongoing expenses for society. One has to comprehend the benefits of a capitated system of healthcare in the most extreme way to understand why it is worth achieving. The advocates of a fully-capitated system claim that everyone benefits. If you take it to the extreme, no one will ever be sick, and doctors will not receive compensation to not see patients. In a fully capitated system, every person around the globe pays a predetermined amount per per month to health care organizations with the sole aim of ensure that you are fit. This is a noble however, it’s not a realistic goal to attain. Automating the management of diseases is a feasible objective.
The whole concept behind disease management, carried to the extreme, is to visualize the doctor following a patient around all day. This isn’t feasible for most people. The knowledge of the doctor must be made available to the general public in order to cut cost. One approach is to not require that the doctor be present at the location where the patient is treated.
The majority of medical treatment is algorithmic. The method of medicine that is algorithmic means that the diagnosis is based on a series of steps that isolate the root of the problem. Advanced cardiac life support (ACLS) and advanced trauma life support (ATLS) have demonstrated the extent to which healthcare can be improved through setting standards. Certain standards could be translated into medical algorithms that can be used to establish the standards of care for doctors. 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 needed to contact assistance. 7, 1876. Telemedicine is still an one-to-one relationship. The phenomenon of telemedicine depends, in part, on the best practices guidelines that help make the practiceof medicine uniform.
The management of diseases is nothing less than the re-design of the procedure of medicine. The issue with medicine was mostly an issue of information and the arrangement of the information. Personal computers and standardization have made it possible to make advances in the management of diseases. The past, doctors were the “arranger” of medical data. However, these tasks can now be done in an automated way with the”lever” of telecommunication and computer technologies.
Coordinating the care of patients throughout the health system from birth to death is known as the process of managing disease. There is a program to cover every stage of a person’s life, including prevention, diagnosis, treatment, rehabilitation. It involves managing not just the patient suffering from an illness as well as the healthy person. Providers often focus on the expensive, intensive treatment of patients suffering from acute illness. Diseasemanagement advocates seek a greater concentration on preventive, holistic treatment to improve the health of the entire population. In a way, disease management attempts to take the practice of medicine from the control of doctors and put it in the hands of patients.
The majority of “knowledge that is based” clinical reasoning can be performed better and more reliability by computers. The accessibility and democratization of healthcare will be made possible by technology. An automated system that streamlines the process of practicing medicine especially in the area of disease-management, and which allows patients to play a major beneficial role in their medical health care is highly sought-after. A system like this should provide a sustainable, substantive, and significant competitive advantage in the health care market that is capitated. This system should be capable of automatically identifying crucial points within any disease process to ensure that treatment can be economically, clinically and humanistically enhanced.
One of the embodiments is an automated system to encode the patients’ subjective pain experience. The system is comprised of an application that encodes a patient’s subjective pain description to be used as a measure of pain. A pain code array is a group of encoded numeric numbers representing different aspects of patient perception of pain.
Another embodiment provides an electronic method for coding pain codes into descriptions for patients. This is accomplished by the storage of a certain number of aspect words in a file and receiving one or more aspect word from the patient to describe pain. Subcodes are converted into subcodes. After that, the subcodes are combined into a paincode array.
In a different embodiment it is a method of decoding the descriptions of pain from an array of pain codes, the method comprising retrieving an array of pain codes containing one or more subcodes from a storage location of the array of pain codes; and decoding the subcodes in the array of pain codes into subjective aspect words.
In another embodiment, there is a computer usable medium having computer readable program code embodied therein for representing a description of a pain in a digitized form for adjusting therapy, the computer readable code comprisinginstructions for storing a listing of aspect words describing a pain experienced by a patient; receiving a selection of an aspect word from the listing of aspect words; and converting the received aspect word into an integer subcode that represents thereceived aspect word.
In another embodiment the computerized method for diagnosing medical conditions which involves the process of converting the subjective perception of a patient of pain into a pain code; and indexing a database of diseases using the pain code, thereby diagnosing a condition.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA refers to functions in software that may comprise ” Software as a Medical Device” (SaMD), and “Software in Medical Device (SiMD) ), which is software that is integral to (embedded in) a medical device.
Section 201(h) of the Federal Food Cosmetics, Drug, and Act, 21 U.S.C. 321(h)(1) defines an medical device as instrument, apparatus, instrument an instrument, device, implant, in vitro reagent, or other similar or related article, including accessories or components, which is . . . (b) designed for use to diagnose diseases or other conditions, or for the treatment, mitigation, treatment, or prevention of diseases for animals or humans, or (c) is designed to alter the structure or the function of the human body or any animal.? To be classified as a medical device and thus subject to FDA regulation the software must satisfy the minimum of the following requirements:
- It must be intended to be used to diagnose or treat patients; or
- It is not intended to change the structure or function of the body.
If your software is designed to be used by healthcare professionals to diagnose, manage or treat hospital patient records or other healthcare facilities, the FDA is likely to view such software to be medical devices that are subject to review under the regulations.
Is Your Software a Medical Device?
FDA’s current oversight that takes into consideration the functions of the software, not the platform is designed to ensure that FDA applies its regulatory oversight to only medical devices that have functions that pose danger for patient safety. Some examples of Device Software and Mobile Medical Apps FDA is focused on
- Software functions that aid patients with diagnosed psychiatric conditions (e.g. post-traumatic stress disorder (PTSD), anxiety, depression, or obsessive compulsive disorder) keep their behavioral strategies for coping by providing a “Skill of the day” method of behavior or audio messages that the user 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 make use of GPS location data to warn asthmatics to be near high-risk locations (substance users), or to alert them to environmental conditions that could trigger symptoms.
- Software functions that employ video and video games to motivate patients to perform their exercises in their own homes;
- Software functions that require the user to input the herb or drug they wish to take concurrently and provide information about the likelihood of interactions being reported in the literature, as well as an explanation of the kind of interaction was observed;
- Software functions that make use of the characteristics of the patient like age, sex and risk factors for behavioral health to offer specific screening for patients as well as preventive counseling from well-known, established experts;
- Software functions that utilize a checklist to identify the most common signs and offer guidance on when to see an acupuncturist.
- Software functions allow users to navigate through a questionnaire about their symptoms and then make a recommendation on the best type of health care facility for the patient.
- The mobile applications allow users to make pre-specified nurse calls or emergency calls with cell phone or broadband technology.
- Apps that allow caregivers or patients to send emergency notifications to first responders using mobile phones
- Software functions that track the use of medicines and give users user-configured reminders for improved drug adherence
- Software functions that offer patients with a way to access their own health information, such as access to data gathered during a previous clinical visit or historical trends, and comparison of vital signs (e.g., body temperature and heart rate, blood pressure, or respiration rate);
- Software features that combine and display trends in personal health events (e.g. hospitalization rates or alert notification rates);
- Software functions allow the user to collect (electronically or manually input) blood pressure data , and send this information via e-mail, track and trend it, or add it into a personal or electronic health record;
- Mobile applications that give reminders about oral health or monitoring tools for people suffering from gum disease;
- Apps that offer mobile guidance and aids for patients suffering from prediabetes;
- Mobile applications that display at the right time pictures or other messages to an addict who is trying to end their addiction;
- Software functions that give safety and drug interaction information (side effects and interactions with drugs, active ingredient, active ingredient) in reports based on the demographics (age and gender), current diagnosis (current medications), and clinical information (current treatments).
- Software functions allow the surgeon to have the list of suggested intraocular lens strengths and the recommended the axis of implantation, based on information provided by the surgeon (e.g. the expected surgically-induced astigmatism that is likely to occur or patient’s axial length as well as corneal astigmatism prior to surgery, etc.)
- Applications, mostly mobile which convert a mobile platform to medical devices that are regulated.
- Software that can be connected to a mobile device by using a sensor or lead that measures and displays the electrical signals produced by the heart (electrocardiograph, ECG).
- Software that connects sensors or other devices to the mobile platform to view, record and analyze eye movements in order to identify balance disorders
- Software that asks potential donors about their donor history and records , and then transmits the answers to an institution for blood collection. This software is used to determine if a person is eligible before collecting blood or any other component.
- Software that is connected to the device’s type in order to control its operation function, or energy source.
- Software that changes the settings or functions of an infusion pump.
- Software that regulates inflation or deflation of a blood pressure cuff
- Software used to calibrate hearing aids and to evaluate the electroacoustic frequencyand the characteristics of sound intensity, and emanating from hearing aids master hearing aids, group hearing aids or auditory trainers in groups.
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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