Clinical Decision Support, LLC (Nashville, TN)

A method and system for allowing a patient to access an automated procedure for controlling a specific health issue called a disease. The system performs disease management with complete automation, using periodic interactive dialogs with the patient in order to collect health state assessments from the patient to analyze and monitor the progress of the disease, to review and adjust treatment to optimal levels, and also to provide the patient advice on managing symptoms, treatment and flare-ups and acute episodes of the disease. Medical records are regularly updated and the progress of the illness is documented and monitored, and the patient’s treatment preferences are saved and utilized to offer medical advice based on the current situation of the disease. The system compares an already stored general trend curve of disease to the specific disease curve of a patient and then offers an automated response, like altering the dosage of therapy.

1. Field of the Invention

The invention generally refers to systems for medical knowledge, and particularly, to systems that allow for computerized long-term management of patients’ diseases.

2. Description of the Technology Technology

Health is the ground upon which we live our lives. Medicine includes diagnosis as well as treatment. Diagnose refers to determining the cause of the patient’s issue; treating is the application of the most effective therapy available. The treatment plan may not be able to treat all illnesses.

For the remainder of a person’s life the need for a treatment plan, called therapy, may be required to treat diseases like asthma and diabetes. The illness is treated and not treated in this particular instance. Disease management may be defined as the process of managing a patient with an established diagnosis, in the hope of providing patient education and monitoring to prevent symptom flare ups as well as acute episodes of the disease to avoid expensive medical interventions and improve patient health. Since different patients respond to different treatment options, the therapy portion of disease management must be tailored to the patient’s requirements.

There is a fervent desire to lower costs, as disease management can result in recurring expenses for the society. One must understand the benefits of a capitated system of healthcare in the extreme to see why it is worth achieving. People who advocate for a fully capitated system claim that everyone will win. Taken to the extreme nobody will ever be sick and doctors will be compensated for not seeing patients because there wouldn’t be any patients. In a system that is fully capitated everyone around the globe pays a predetermined amount per per month to health maintenance organizations that’s sole goal is to keep you healthy. This is a noble objective, but it is not easy to reach. Automating the management of diseases is a viable objective.

The entire idea behind managing disease, taken to its extreme, is to envision doctors following patients all day. Of course this isn’t a viable solution for the majority of the population. The knowledge of the doctor should be available to the general public in order to cut costs. One option is to not demand that the doctor be present at the location where the patient is taken care of.

A large portion of medicine is an algorithmic. The algorithmic approach to medicine means that the diagnosis is based on a sequence of steps that identify the cause. Advanced cardiac life support (ACLS) and advanced trauma life support (ATLS) have shown how much medical care can be improved by setting standards. The standards could be utilized to create medical algorithms that will aid doctors in setting the standards for medical care. 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. In reality the first words spoken on the phone were an appeal to help, in the sense that Alexander Graham Bell had just spilled acid from the battery (for the batteriesfor the telephone) and declared, “Come here, Mr. Watson, I need you” on the. 7th, 1876. Telemedicine today is still a one-to-1 relationship. The concept of telemedicine rests in large part on guidelines for best practice that in making the practice of medicine more consistent.

The management of diseases is nothing less than the re-design of the medical practice. Medicine was initially a matter of data and the arrangement. Due to the advancement of the personal computer as well as standards, there are now advancements in the field of disease management. In the past doctors were the “arranger” of medical data. However, these duties can now be performed with ease using the”lever” of telecommunication and computer technologies.

Management of diseases can mean coordinating care for patients across the entire spectrum of health care from birth to death. It is a plan that is available to all aspects of a person’s life, which includes prevention, diagnosis, treatmentand rehabilitation. This involves taking care of not only those with the illness, but also healthy patients. A lot of times, healthcare providers concentrate on providing costly and intense treatment to patients who are experiencing severe episodes of illness. To improve the overall health and wellbeing of all people the disease management community advocates for a greater emphasis on preventative, holistic care. Disease management is, in a sense a way to receive medical treatment from physicians and placing it in the hands patients.

The majority of “knowledge based” clinical reasoning is able to be done with more efficiency and secure through computers. The increasing accessibility and democratization of medicine will be driven by technology. An automated system that streamlines the process of practicing medicine, particularly in the field of disease management, and which allows patients to play an important role in their medical health treatment is highly sought-after. Such a system should give an ongoing, substantial and significant competitive advantage in a capitated health caremarketplace. The system must be capable of automatically identifying critical points within any disease process in order to allow intervention to be clinically, economically, and humanistically optimized.

In one embodiment of the invention described hereinafter, there is a computerized critical curve evaluation method, which includes providing the critical curve of a particular disease, providing a plurality of health indicators within an electronic medical record corresponding to a specific patient with the particular disease and comparing at most one of these health parameters to the critical curve to gather information on health assessment.

In a further aspect of the present invention it is a system for performing an electronic critical curve assessment which includes a computer; storage communicating with the computer, configured to store an electronicmedical record for each patient of a plurality of patients and an application for managing disease by the computer and designed to connect to a critical curve of a disease that generates a number of health parameters in theelectronic medical record corresponding to a particular patient having the disease, and compare at least one of the health parameters to the critical curve to gather health assessment information.

Another element of the invention is a method that can perform a computerized critical curve assessment. The system is comprised of an electronic computer as well as means of communicating with it to store electronic medical records corresponding to every patient. Disease management tools are also provided by the computer to access an essential path to treat the specific disease, and for creating a variety of health indicators in an electronic medical record that relates to a particular patient.

In a different aspect of the present invention there is a computer-readable medium having computer readable program code that is embodied in it for performing an assessment of a critical curve, the computer readable code having instructions for accessing a critical curve associated with a particular disease, generating a plurality of health indicators in the electronic medical record that corresponds to a specific patient suffering from the particular disease, and generating a comparison of at least one health parameter to the critical curve to gather health assessment information.

Another feature of the invention is the process of generating an essential curve to determine the necessity for medical intervention. This involves taking the patient’s health parameters, adding current health-related parameters to the patient’s medical history and plotting the patient-specific curve, which incorporates health parameters measured against the time. Analyzing statistical data on this specific critical curve for the patient, accessing a standard critical curve for the condition, and comparison of the data from the patient-specific critical curve to the standard curve to determine if there is been any changes.

Another element of the invention is a way that generates an essential curve to evaluate the necessity for medical intervention. The system is equipped to identify health-related parameters specific to disease by analyzing the patient. It also provides methods to include current health parameters to the patient?s medical history. Means for plotting the patient-specific curve, which is used to measure the health parameters over time. There is the ability to carry out statistical analysis of this patient-specific critical curve. Additionally, there is a way to access a standard critical curve. This allows for comparisons between the patient-specific curve and the standard curve.

In a different aspect of the present invention, is a computerized critical curve assessment system that includes means for providing a critical curve for a particular disease, means for providing a plurality of health parameters in anelectronic medical record for a particular patient having the particular disease and means to compare at least one of the health parameters to the critical curve in order to get health assessment data.

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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 are functions of software that are integral to (embedded in) medical device.

Section 201(h),?21 U.S.C. 321(h)(1), defines a medical device as ?an instrument, apparatus, device an instrument, device implant an in vitro reagent or other similar or related device, which may include accessories or components, which is . . . (b) designed for use in the diagnosis of diseases or other conditions, or for the cure, mitigation, treatment, or prevention of diseases in animals or man or (c) is designed to affect the structure or function of the human body or any animal.? To be considered a medical device and therefore subject to FDA regulation the software must meet the minimum of the following criteria:

  • It must be designed to aid in diagnosing or treating a patient; or
  • It is not intended to affect the structure or perform any functions of the body.

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

Is Your Software a Medical Device?

The FDA’s oversight currently, which focuses on the functionality of the device more than its platform, will ensure that FDA uses its oversight to medical devices that have functions that could pose risks to the safety of patients. Some examples of Device Software and Mobile Medical Apps that FDA is focusing on include

  • Software functions that aid patients suffering from diagnosed psychiatric illnesses (e.g. post-traumatic stress disorder (PTSD) or anxiety, depression, or obsessive compulsive disorder) maintain their behavioral ability to cope by offering an “Skill of the Day” behavioral technique or audio-based messages users can access when experiencing increased anxiety;
  • Software functions that provide periodic educational information, reminders, or motivational tips to smokers seeking to quit, addicts who are recovering from addiction or pregnant women;
  • Software functions that use GPS location information to notify asthmatics to conditions in the environment that may cause asthma symptoms or warn an addict (substance addicts) in proximity to a specified high-risk area;
  • Software that makes use of games and videos to motivate people to do their take part in exercise at home.
  • Software functions that require the user to input the herb or drug they wish to take in conjunction and offer information on the likelihood of interactions being reported in the literature as well as an explanation of the kind of interaction was observed;
  • Software functions that utilize patient characteristics like age, sex and other risk factors for behavior to offer specific screening for patients, counseling , and preventive advice from well-known and established authorities;
  • Software functions that utilize a checklist to identify the most common signs and offer information on when to visit a doctor.
  • Software functions assist users in completing the questionnaire of signs and symptoms to provide an indication of the kind of health facility that is suitable to their requirements;
  • These mobile applications allow users to make nurse calls, or emergency calls using the internet or cell phone technology.
  • Mobile apps that enable the patient or caregiver to design and send an alarm or general emergency alert to first responders.
  • Software functions that track the use of medication and offer user-configured reminders to ensure better compliance with medication;
  • Software functions give users access to their health records. This includes historical trending and comparisons of vital indicators (e.g. body temperature, heart rate, or blood pressure).
  • Software functions that reveal trends in personal health events (e.g. hospitalization rates or alert notification rates)
  • Software functions that allow the user to collect (electronically or manually input) blood pressure data , and transmit this data via email or track and analyze it, or upload it to an electronic or personal health record;
  • Mobile apps that provide reminders about oral health or tracking tools for those suffering from gum disease;
  • Apps that give mobile users access to information and other tools for patients with prediabetes;
  • Mobile apps that display, at opportune times pictures or other messages to an addict who is trying to stop addictive behavior;
  • Software functions that report drug-drug interactions, as well as relevant information about safety (side effects or drug interactions, active ingredient) in a report based on demographic information (age gender, age) and medical data (current diagnosis) and the current medication; and
  • Software functions that allow the surgeon to have an inventory of intraocular lens powers and recommended the axis of implantation, based on information supplied by the surgeon (e.g. the predicted surgically induced astigmatism patient’s axial length , preoperative corneal astigmatism, etc.)
  • Applications, mostly mobile which transforms a mobile platform into a regulated medical device.
  • Software that connects to mobile platforms by using a sensor or lead to measure and display the electrical signals generated by the heart (electrocardiograph, ECG).
  • Software that connects a sensor to the mobile platform, or other tools in the platform, that allow users to see or record the eye movements in order to diagnose balance disorders
  • Software that questions potential donors about their history with donors and records , and then transmits the answers to an institution for blood collection. The software helps determine if a person is eligible to collect blood or any other component.
  • Software that connects to an existing device in order to control the device’s operation, function or power source.
  • Software that alters the functions or settings of an infusion pump
  • Software that controls the deflation or inflation of the blood pressure cuff
  • Software that can calibrate hearing aids and evaluates the characteristics of sound intensity and electroacoustic frequency 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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