Clinical Decision Support LLC (Nashville, TN)
What is a Software Medical Device for Computerized medical diagnostic system that utilizes the process of list-based lists
1. Field of the Invention
The present invention relates to computerized medical diagnostics systems. Particularly, embodiments of the present invention pertain to computerized systems for diagnostics based on time of the patient’s condition through the using dynamic data structures.
2. Description of the Technology Technology
Health care expenses currently comprise a significant portion of the United States Gross National Product and are growing faster than any other part of the Consumer Price Index. In addition, typically due to the financial inability of many to afford medical care that many suffer from being deprived of even the most basic medical services and information.
People often delay or are prevented due to cost or the inconvenience of seeking medical treatment. Many diseases could be prevented if the public had access to a simple, affordable, and unrestricted access to medical information. Early diagnosis and treatment of many diseases can prevent a lot of people from getting to the worst stages. This would reduce the burden on the health system which could result in massive financial difficulties. The United States faces health-related problems of immense proportions, and the current solutions aren’t effective.
There have been many prior attempts to address the issue of health care automation. One of these attempts has been implemented in the form of a dial-in library of answers to medical questions. Other efforts have focused on the doctors with computerized tools for use during an exam. These techniques are either static or based on algorithms. It is ideal to have an automated method of giving medical advice and diagnosing patients that is reliable fast, precise, and accurate. This modular medical advice system will be able to adjust to changing medical conditions or detection methods.
One way of conducting an interview of a patient includes the use of medical diagnostics scripts. What is required is a reliable method of conveying the knowledge of medical experts in their field in the format of a script. The scripts must employ dynamic structures that allow you to rapidly and effectively identify the patient.
List-Based Processing allows you to identify diseases by arranging symptoms as well as diseases and other questions in a set of of nested disease, symptom, and Question (DSQ), lists. The lists are then able to be processed to form an adialogue to a patient. Each patient’s question generates one from a set defined responses, and each one of them creates one from a set of questions. This creates a dialog that generates symptoms from patients. The symptoms are processed and weighted to determine if a disease is in or out. The list of diseases that are ruled out is used to determine the diagnosis. A List-Based Processing system arranges medical information into formal structured lists or arrays, and then applies an algorithm to these lists to automatically select the next question. The responses to the questions lead to more questions and ultimately to a diagnosis.
In one embodiment there is a computerized diagnostic method, comprising a) keeping the list of illnesses on a computer, in which each disease is accompanied by symptoms listed and where every symptom is linked to a list ofquestions, b) collecting medical information from a user and the third step is) selecting one of the diseases from the list of illnesses in accordance with the medical information, d) selecting a symptom that is associated with the selected disease, the final step is) asking at minimum one question from the list of questions associated with the selected symptom to get additional medical information from the patient, then) finding out if an individual patient needs to be identified with the disease, based on the medical information, and) reporting the findings of the determining to the patient.
In another embodiment there is a computerized diagnostic method, comprising storing a list of diseases on a computer, wherein each disease is associated with a list of symptoms, and wherein each symptom is associated with a list of questions,repetitively asking questions to elicit responses, wherein the responses establish symptoms, determining the probability that a patient has a given disease based on the established symptoms, and declaring a diagnosis based upon the determinedprobability.
Another type of device is an electronic diagnostic system. It is capable of keeping a list with diseases and symptoms with the symptom’s list. The list also includes ways to frequently ask questions in order to get answers.
In a further embodiment, there is an electronic medical diagnostic system that comprises a storage configured to keep a list of ailments and where each disease is associated with a list of symptoms, and each symptom is associated with the list of questions, a storage configured to store an engine script that, when run repeatedly asks questions to elicit responses, wherein the responses indicate symptoms, and determines the likelihood that a patient is suffering from the disease in question based upon the symptoms that are known, and makes a diagnosis based upon the determined probability and a processor that is configured to run the script engine.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA could refer to functions in software, which include ” Software As a Medical Device” and “Software in Medical Device(SiMD)”, which are software that is integral (embedded in a) a medical device.
Section 201(h) of the Federal Food, Drug, and Cosmetic Act, ?21 U.S.C. 321(h),(1) defines the term “medical device” as apparatus, instrument or machine implants, devices, contrivances in vitro regulator, or any other similar or related articles in addition to a component or accessory. . . (b) is designed for diagnosis or treatment of diseases or other ailments in humans or animals. (c) is designed to modify the structure or function of human bodies or animals. Thus, to be considered a medical device and therefore subject to FDA regulation, your software must satisfy one of two requirements:
- It should be designed for use to diagnose or treat a patient; or
- It is not intended to alter the structure or purpose of the body.
If your program is intended to be utilized by healthcare professionals to diagnose, treat or manage patient data in hospitals, the FDA is likely to consider the software to be medical devices that are subject to review under the regulations.
Is Your Software a Medical Device?
In accordance with FDA’s current oversight strategy that considers the function of the software, rather than its device’s platform, FDA will apply its supervision only to medical devices with functions that be a risk to the safety of patients. Examples of Device Software and Mobile Medical Apps FDA is focused on
- Software functions that help patients suffering from diagnosed mental disorders (e.g. anxiety, depression, post-traumatic stress disorder (PTSD), etc.) through the use of “Skill of the Day” an approach to behavior or audio message that users can access when they are suffering from anxiety.
- Software functions that provide regular reminders, motivational advice, and educational information to those recovering from addiction or smokers trying to quit;
- Software functions that use GPS location data to warn asthmatics when they’re close to high-risk areas (substance abusers) or warn asthmatics to environmental conditions that may trigger symptoms.
- Software that utilizes games and videos to motivate patients to take part in exercise at home.
- Software functions that prompt users to choose which herb or drug they wish to use at the same time. They also provide details about interactions and give an overview of the kind of interaction.
- Software functions that consider specific characteristics of the patient, like gender age, gender, and other risk factors, to offer specific counseling, screening and prevention advice from well-established and highly-respected authorities.
- Software functions that make use of the list of symptoms and symptoms to provide guidance on when it is appropriate to visit a doctor and what to do next.
- Software functions guide users through a list of symptoms and signs to give a recommendation on the health facility that is most suitable to their needs;
- Mobile apps are intended to let users initiate a nurse call or emergency call using broadband or mobile phone technology;
- Apps that permit patients or caregivers to notify emergency situations to first responders using mobile phones
- Software that monitors medications and provides user-configured reminders to increase the adherence to medication.
- Software functions that give users access to their health information. This includes historical trends as well as comparisons of vital signs (e.g. body temperature, blood pressure, or heart rate).
- Software functions that show trends in personal health events (e.g. rate of hospitalization or alert notification rates)
- Software features let users either manually or electronically enter blood pressure data, and to share it via e-mail or track it, and then trend it, then upload it to your personal or electronic health record.
- Mobile applications that give dental health reminders and tracking tools for users with gum disease;
- Apps that give mobile users access to information and aids for patients suffering from prediabetes;
- Apps that allow users to display pictures and other messages on mobile devices which can be used by users of drugs who wish to end their addiction.
- Software functions that offer interactions between drugs as well as relevant safety information (side effects or drug interactions and active ingredient) as a report based on demographic information (age, gender), medical data (current diagnosis) and the status of current medications and
- Software functions permit the surgeon to identify the optimal intraocular lens strength for the patient, as well as the axis of implantation. The information is determined by the surgeon’s inputs (e.g., expected astigmatism caused by surgery, the patient’s axial length, preoperative cornea astigmatism, etc.).
- Software, typically mobile apps that converts a mobile platform to a regulated medical device.
- Software that connects with a mobile platform via an instrument or lead to monitor and display electrical signals generated by the heart (electrocardiograph; ECG).
- Software that connects a sensor or other tools to the mobile device so that it can view eye movements in order to identify balance problems.
- Software that asks potential donors about their history with donors and records and/or transmits those answers to a blood collection facility. The software can determine the eligibility of a potential donor to donate blood or any other component.
- Software that is connected to an existing device type for control of its function, operation, or energy source.
- Software that changes the settings or function of an infusion pump.
- Software that regulates the inflation or deflation of a blood pressure cuff
- Software to calibrate hearing devices and analyzes the sound characteristics and electroacoustic frequencies of hearing aids, master hearing aids and hearing aids 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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