Clinical Decision Support, LLC (Nashville, TN)

Structure-based processing is a method to diagnose diseases. It involves organizing the symptoms and illnesses into questions, symptoms and disease structures. These structures can be processed in order to form dialogue with the patient. A structure-based processing system organizes medical knowledge into formal structures and implements these structures using a structure engine to automatically select the next question. The questions are then answered by patients and lead to more questions, which eventually leads to a diagnosis.

1. Field of the Invention

The scope of the invention concerns computerized medical diagnostic systems. Particularly, examples of the invention relate to a computerized system that allows for diagnostics based on time of a patient’s medical complaint.

2. Description of the Related Technology

Health care expenses currently comprise large proportions of United States Gross National Product and are generally growing faster than any other component of the Consumer Price Index. A lot of people are not able to access basic medical information and care because they cannot pay for the services.

Many people put off seeking, or are prevented from seeking medical care because of cost and time restrictions or even inconvenience. Many diseases could be prevented when the general public had access to access to a simple, affordable and unlimited access to medical information. Likewise, the earlier detection and treatment of several diseases could prevent many patients from reaching the advanced levels of illness, the treatment for which is a significant part of the financial burden that is attributed to our nation’s healthcare system. The United States faces enormous health-related issues and the solutions currently in place aren’t very effective.

There have been a variety of previous attempts to address the healthcare problem using automation. Some of these attempts have taken the form of a library that can be dialed in of answers to medical questions. Others have focused on providing doctors with computerized aids that aid them during examinations. These are either static or are based on algorithms. It is ideal to use an automated system for providing medical advice and diagnosing patients that is efficient fast, precise, and accurate. This modular medical advice system is needed to be able to adapt to the latest diagnostic or medical conditions.

Structure-based processing is a way for diagnosing illnesses which works by arranging symptoms, diseases symptoms, symptoms, as well as questions into a set of related disease, symptom and question structures, like lists or objects and in a manner that the structures are processed to initiate a conversation with the patient. Every question asked to the patient triggers one of a series of predetermined responses. Every answer is followed by a set of defined questions. This creates a dialogue that produces symptoms from the patient. The symptoms are then assessed and evaluated to determine whether the patient is a potential candidate for a particular disease. The set of ruled-in diseases determines the diagnosis. Structure-based processing systems arrange medical information into formal structures. The structures are then executed on structures engines (such as an engine that lists) to determine the next query. Answers to these questions lead to additional questions, and eventually , to an diagnosis.

A preferred embodiment of the invention includes a method of automated diagnosis or management of a medical condition, which includes providing a variety of disease objects, each disease object that is associated with a number of symptom objects, and assigning a weight for each symptom, in which case a particular disease object may include a preferred weight for one or more preferred symptoms, as well as an alternative weight for one or more other symptoms, wherein alternative symptoms are chosen from a list of archived symptoms that are accessible to reuse.

The second version of the invention is an automated diagnostic system that works to determine the condition of a patient. The objects comprise at least one of the following: a disease object or a symptomobject; a valuator objects or a question object a node object; and an object that is a candidate.

Another embodiment of the invention consists of an automated diagnostic system which includes many objects. These objects may include at least one of the plurality of disease objects and at least one or more symptom objects. Most of these objects carry out their own functions and others rely on other objects to complete their tasks.

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What is a software medical device?

The FDA refers to functions in software which may include ” Software as a Medical Device” (SaMD) as well as “Software in a Medical Device (SiMD) ), which is software that is integral to (embedded inside) a medical device.

Section 201(h) of the?Federal Food Cosmetic, Drug, and Act, 21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, instrument or machine, contrivances, implant, in vitro regulator, or other similar or related items, as well as an accessory or component. . . (b) intended for use to diagnose diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, 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 regulations, the software must meet the minimum of these conditions:

  • It is essential to use it in diagnosing and treating patients.
  • It is not intended to modify the structure or perform any purpose of the body.

If the software you use is designed to be used by healthcare professionals to diagnose, treat, or manage patient information in hospitals and other medical facilities, the FDA is likely to consider the software to be medical devices subject to regulatory review.

Is Your Software a Medical Device?

According to FDA’s current oversight strategy that considers the function of the software more than its platform, FDA will apply its supervision only to devices for medical use that possess capabilities that pose a danger to the safety of patients. Some examples of Device Software and Mobile Medical Apps FDA is focused on

  • Software functions to help those suffering from psychiatric disorders diagnosed (e.g., post-traumatic stress disorder (PTSD) depression, anxiety, obsessive compulsive disorder) maintain their behavioral strategies for coping by providing an “Skill of the day” behavioral technique or audio-based messages the user can use when they are experiencing an increase in anxiety;
  • Software functions that provide regular reminders, motivational support, and educational information to patients who are recovering from addiction, or who are who are trying to quit.
  • Software functions that make use of GPS location data to alert asthmatics when they’re near areas of high risk (substance users) or to warn them of potential environment-related conditions that could trigger symptoms.
  • Software that utilizes games and videos to motivate people to do their take part in exercise at home.
  • Software functions that ask a user to enter which herb and drug they wish to take concurrently and provide information about the likelihood of interactions being reported in the literature, as well as a summary of what type of interaction was described;
  • Software functions that are able to take into consideration the characteristics of the patient, like gender age, gender, and other risk factors, to provide specific counseling, screening and prevention recommendations from established and respected authorities.
  • Software functions that make use of a list of typical symptoms and signs to give the possibility of health conditions and advise on when to see an expert in health care;
  • Software functions guide the user through a checklist of symptoms and signs to provide a recommendation for the type of health facility that is most suitable to their requirements;
  • The mobile apps enable users to make nurse calls or emergency calls using broadband or cell phone technology.
  • Mobile applications that permit the patient or the caregiver to design and send an alert or general emergency notification to first responders;
  • Software that monitors medications and offers user-defined reminders that improve medication adherence.
  • Software functions that provide patients a portal into their own health data for example, access to information captured during a prior visit to a doctor or historical trending and comparison of vital signs (e.g., body temperature or blood pressure, heart rate or respiration rate);
  • Software functions that display trends in personal healthcare incidents (e.g. rate of hospitalization or alert notification rates)
  • Software functions that allow users to gather (electronically or manually entered) blood pressure data , and share this data through e-mail, track and trend it, or add it to a personal or electronic health record.
  • Apps that offer mobile apps for tracking and reminders about oral health or devices to monitor users who suffer from gum disease.
  • Apps that give mobile users access to information and tools for prediabetes patients;
  • Mobile apps that show when appropriate, images or other messages for an addict who is trying to end their addiction;
  • Software functions that report interactions between drugs as well as relevant safety information (side effects and interactions with drugs, active ingredient) as a report , based on demographics (age, gender) as well as medical information (current diagnosis) and current medications as well as
  • Software functions give the surgeon a list of recommended intraocular lens strengths and the recommended the axis of implantation, based on information inputted by the surgeon (e.g. an expected surgically-induced astigmatism that is likely to occur, the length of the patient’s axial axis and preoperative corneal astigmatism, etc.)
  • Applications, mostly mobile which convert the mobile platform into medical devices that are regulated.
  • Software that can be connected to mobile platforms using a sensor or a lead to measure and display the electrical signals produced by the heart (electrocardiograph, ECG).
  • Software that connects a sensor or other tools to the mobile device to view and record eye movements to diagnose balance problems.
  • Software that gathers information about potential donors and transmits the information to a blood collection facility. This program determines the eligibility of a potential donor to donate blood or other components.
  • Software that is connected to an existing device to control the device’s operation, function or power source.
  • Software that alters the functions or settings of an infusion pump.
  • Software that regulates inflation or deflation a blood pressure cuff
  • Software that adjusts hearing aids, and also evaluates the characteristics of sound intensity and electroacoustic frequencies 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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