Certain medical practices require a quick and precise diagnosis. In order for a physician (or other medical person) to swiftly and accurately identify a problem, they must be aware not only of all of the possible conditions or diseases associatedwith an individual finding or set of findings as well as the specific symptoms to search for in the patient.
In the event of a specific presentation, like chest pain blurred vision, chest pain, or cardiac arrhythmias doctor should be aware:
1.) Which diseases or conditions should you be concerned about (e.g. what are the possible causes of disease);
2.) what manifestations or results to be looking for;
3) the importance of the importance of the finding in ruling in or ruling out each possible disease or condition.
This information is typically derived from medical journals or experience. While experience and the teachings of medical journals are invaluable, it is unrealistic to expect that a physician will be aware of every possibilityassociated with a set of findings, or that he will be aware of every finding that he should consider. It is also unrealistic to expect that a physician will have instant recall of all the information he’s learned. The use of textbooks or journals is not a good idea for many medical practices.
One example of data that can be useful in diagnosing a specific illness and/or disease is the frequency with which an individual finding is observed in patients who suffer from an illness or condition in consideration. Another example of useful information is its specificity, or “evoking the power”. This is the answer to the question “Given this finding in a patient, how strongly should I (the doctor) consider it an explanation for the diagnosis?”
The frequency is the amount of time patients with the disease or illness have the condition. However, the specificity is the rate of patients who do not have the condition experience the same finding. Both the frequency and specificity of findings are vital and crucial for a correct diagnosis, however they are examples of data that no physician can always be expecting to have at access.
The prior art typically contemplates computer programs that employ symbolic reasoning or artificial intelligence to assist physicians in the diagnosis of general internal medicine. For example, see Randolph A.Miller, et al., Internists: I A Computer-Based Experimental Diagnostic Consultant for General Internal Medicine, The New England Journal of Medicine, Vol. 307, 8 p. 468-475 (August 1982). Michael B. First, et al., QUICK (QUick)Index to Caduceus Knowledge; Using The Internists–I/Caduceus Knowledge Base As An Electronic Textbook of Medicine, Computers and Biomedical Research, Vol. 18, pp. 137-165 (1985). U.S. Pat. Nos. 4,290,114 (Sinay), and 4,733,354 (4,733,354 (Potter and co.). However, these systems are generally complicated to operate and don’t rapidly and efficiently convey diagnostic information to the doctor or other medical personnel. They are not able to provide the required speedy, accurate diagnostic information.
It is unlikely that any device, even an electronic computer programmed to ever be able to replace the expertise and intuition of a human physician when rendering an accurate medical diagnosis. Physicians must utilize the resources available to give rapid and accurate diagnoses. These resources should complement the physician’s ability to identify the condition of a patient.
So, an objective of the invention is to provide a computer-aided method of presenting diagnostic information to a physician or other medical professional in such a manner that conditions and/or diseases can be quickly and accuratelydiagnosed.
Another goal of the invention is to provide an electronic bedside diagnostic system.
The present invention also intends to offer a computer-aided research program that can be used by doctors and other medical personnel to study a range of ailments and diseases.
The invention is an interactive computerized apparatus and method for providing medical information to aid in diagnosis and study of disease. The invention offers an interactive computerized device that has processing means for processing dataindicative for disease findings. This includes assigning color codes for the symptoms of disease. A database with data is also available. Input means are offered for indicating at the very least one diagnosis or finding to the system for processing. Output means provide a color display of diseases as well as categories of findings.
In the preferred embodiment, the processing means is a computer, the color display is a CRT or an LCD color display, and the input means is the keyboard or light pen.
As described in this invention the use of colors in conjunction with a computer offers many advantages over the current methods of communicating diagnostic information using traditional journals, books, or computers. Utilizing color in the present invention allows for quick and clear communication of the aspect of diagnostic information which is the most difficult to grasp and remember: the significance of the presence or absence of findings in ruling out or identifying associateddisease possibilities. The color-coded symbols make it much easier for doctors to understand and retain diagnostic information. This invention lets doctors quickly recall and apply vast amounts of diagnostic information at the bedside. It is now possible for a physician to go through a large number of disease possibilities quickly and efficiently, and yet also thoroughly and systematically. A physician or another user can utilize colors to guide him through the diagnosis process. The significance of the finding the user is trying to find is well-known. But, the present invention is not intended to replace the physician’s thought or judgment. It is merely an aid to the.
The device and the method of the invention convey to the doctor the rationale behind the diagnostic decisions that are made for the doctor, i.e., why a group of illnesses are considered to be likely candidates for diagnosis. The physician can then be capable of quickly, effortlessly and efficiently alter or reverse the computer’s decisions and thus remain in complete control of every step of the diagnostic process. This is a distinct advantage over the computers-based diagnostic assistance programs which were recently developed and can replace much of the thinking of doctors.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA can refer to functions in software, which include ” Software As a Medical Device” and “Software in a Medical Device(SiMD), which are programs that are integral (embedded within) medical device.
Section 201(h) of the Federal Food and Drug Act, 21 U.S.C. 321(h)(1), defines the term “medical device” as instrument, apparatus, instrument an instrument, device implant or in vitro reagent or any other similar or related article, including accessories or components that’s . . . (b) is intended to be used to diagnose diseases or other conditions, or in the cure or mitigation of disease, or prevention of diseases in animals or man or (c) intended to affect the structure or function of the body of man or other animals.? To be classified as a medical device and therefore subject to FDA regulations the software must meet the minimum of these criteria:
- It must be designed to aid in diagnosing or treating the patient
- It must be designed to affect the structure or function of the body
If your program is intended to be utilized by healthcare professionals to diagnose, manage, or treat the patient’s information in hospitals and other medical 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?
FDA’s current oversight, which looks at the capabilities of the software rather than the platform will ensure that FDA regulates to only medical devices that have capabilities that pose a risk to patient safety. Examples of Device Software and Mobile Medical Apps FDA is focusing on
- Software functions that aid those suffering from mental illness (e.g. depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) by providing the “Skill of the day”, behavioral technique, or audio messages, which the user can access when they are feeling anxious.
- Software functions provide regular educational information, reminders, or motivational advice to smokers trying to quit, patients who are recovering from addiction or pregnancies women;
- Software functions that use GPS location information to notify asthmatics when they’re near areas of high risk (substance abusers) and to inform them to environment-related conditions that could trigger symptoms.
- Software that utilizes games and video to help patients to exercise at home.
- Software functions that require users to select which herb and drug they’d like to use in conjunction and offer information about whether interactions have been seen in the literature, as well as an explanation of the kind of interaction was described;
- Software functions that are able to take into consideration specific characteristics of patients, such as gender age, gender, as well as risk factors, to provide specific counseling, screening and prevention recommendations from established and highly-respected authorities.
- Software functions that make use of the list of symptoms and signs to provide information on when to visit the doctor and what next.
- Software functions that help users to navigate through a questionnaire about symptoms and to make a recommendation on the most suitable medical facility to treat them.
- Mobile apps that are intended to enable users to make a pre-defined nurse call or emergency call by using broadband or cell phone technology;
- Mobile apps that enable the patient or caregiver to create and send an alert or general emergency message to first responders.
- Software functions that track the use of medicines and give users user-configured reminders for improved compliance with medication;
- Software functions that give patients access to their health data. This includes historical trending and comparisons of vital indicators (e.g. temperature of the body, blood pressure, or heart rate).
- Software functions that aggregate and show patterns in health-related incidents that affect individuals (e.g. rate of hospitalization or alert notification rates);
- Software tools let users electronically or manually enter blood pressure data, to send it out via email, track it and trend it, and upload it into an electronic health record.
- Apps that offer mobile apps to monitor and remind you about oral health or tools for tracking those suffering from gum disease.
- Apps that give mobile users access to information and tools for prediabetes patients;
- Applications that permit users to display images and other messages on their smartphones, which are a great option for users of drugs who wish to end their addiction.
- Software functions that provide information on safety and drug interactions (side reactions and interactions with drugs, active ingredient, active ingredient) in an analysis based on information about demographics (age and gender) as well as current diagnoses (current medications) and clinical data (current treatments).
- Software functions that permit the surgeon to determine the most effective intraocular lens power for the patient, and the most effective axis of the implant based on the information provided by him (e.g. the expected surgically induced astigmatism and patient’s axial length, preoperative corneal astigmatism , etc.).
- Software, usually mobile apps that converts a mobile device into a regulated medical device.
- Software that is connected to an mobile platform using the use of a lead or sensor to display and measure electrical signals from the heart (electrocardiograph; ECG).
- Software that attaches sensors or other tools to the mobile platform in order to view, record and analyze eye movement to detect balance problems
- Software that asks potential donors about their donor history and their records and/or sends those answers to the blood collection facility. This software is used to determine whether a donor is eligible before collecting blood or other components.
- Software that is connected to an existing device in order to regulate its operation, function, or power source.
- Software that changes the functions or settings of an infusion pump.
- Software that regulates inflation or deflation of a blood pressure cuff
- Software is used to calibrate hearing devices and assess the electroacoustic frequencies, audio intensity characteristics, as well as emanating from hearing aids, master hearing aids, hearing aids for groups or auditory trainers for 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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