What is a Software Medical Device for Medical professional monitoring system for professionals and the associated methods
Systems and different kinds of software have been extensively used to assist medical professionals in making diagnoses of patients’ conditions, as well as to assist medical professionals in prescribing particular courses of treatments to treat those diagnosed.
A medical system is an illustration. It was created by the department of Accident and Emergency of Westminster Hospital in London. The system provides advice on the management of chest pain patients in emergency rooms. Another medical system is available under the tradename “ADE Monitor”. It is being developed at Washington University School of Medicine, Division of Medical Informatics. This software is used to analyze the clinical information of patients to detect potential adverse drug events. Another similar medical device is accessible under the trade name “CADIAG II”. It was developed by the Department of Medical Computer Sciences at University ofVienna and the Department of Internal Medicine III. This department of Rheumatology is part of the Department of Internal Medicine I Divisions of Oncology, University of Vienna Medical School. This system is directed to colon diseases, and is a computer-assistedconsultation system to support the differential diagnostic process in internal medicine.
U.S. Published Patent Application No. 2002/0120471 was a recently published patent application. It describes a method that stores different medical guidelines for a variety of health conditions as well as historical information for a range of patients. The patient’s information is collected through the world’s largest communication network (i.e. the Internet) and then used to generate a risk report for each patient, based on the guidelines for medical care in the database. Aphysician’s treatment plan may be generated to reduce the risk of a patient based on guidelines for medical care.
This method, however, could be detrimental as it permits a doctor to become reliant upon an established system, rather than the physician’s own medical knowledge. Furthermore, the system is unable to monitor medical performance in relation to whether the medication prescribed by the physician is proper. This system could lead to a loss of resources.
U.S. Published Patent Application No. 2002/0143579 filed by Docherty and co. discloses a system that identifies opportunities for direct physician intervention to enhance prescribing practices and ensure compliance of patients. In particular, the system collects data about a physician’s prescription practice, and analyzes the data according to guidelines from experts. The system detects any deviation from the established guidelines and gives the physician interventions information.
U.S. Pat. discloses the method of evaluating physician performance, which includes a database that stores the contact between physician and patient. No. No. 5,924,073 in Tyuluman’s name and others. An evaluator is coupled with the database for the purpose of evaluating the data with statistical analysis. The system can be used to define a standard of care for an essential element of patient population. The standards of care can be updated in light of better and more efficient treatments and also identify doctors who performoutside the prescribed standard of care. These systems, however, don’t take into consideration the various standards that a physician must analyze when prescribing medical procedures, i.e., hospital standards and insurance standards, medical standards, etc.
U.S. Published Patent Application No. 2003/0055679 filed by Soll and co. provides a computerized management of patients system that comprises an individual module for patients and a physician module and a database. The system allows patients to enter their personal information into the patient module. The database holds assessments and treatments for medical conditions data that is used to generate an assessment report. The doctor can edit the report and include assessments and management plans. The physician can also choose educational materials to give to the patient as well as a health summary or during a patient interview. This system is heavily dependent on the patient capacity to accurately fill in their personal information.Further it provides access to persons that don’t have the same knowledge of medicine as a medical professional.
Given the background and context, the goal of this invention is to create a system that improves healthcare for patients by reducing medical errors. The present invention also aims to create an apparatus that monitors the medical treatment that patients receive as well as the performance of medical professionals to improve healthcare services by reducing medical errors. Further, it is a goal of the invention to monitor and report on the outcomes of medical procedures. It is still further an object of the present invention to provide a system to improve the effectiveness of medical chart review and the time for receiving payments for medical treatment and medical services. Another object of this invention is to provide secure indexing and search functions which allow the easy access of patient information.
It is also a goal of this invention to provide an instrument that significantly reduces the time for an insurance company to send payments to a medical professional. The present invention is also an objective of the invention to provide updatedmedical treatments information, like new medical standards and procedures, to medical experts. It is yet another object of the invention to minimize any waste of medical resources.
A monitoring system for medical professionals features a user interface which communicates with a global communication network to offer the above features as well as other benefits. The system can also include the patient database, a diagnosis database and medical treatment data databases. Each of these databases can be connected to a global communications network.
The patient database may contain information about a range of patients who have associated with a medical professional. The diagnosis database may include details about diagnosis available to the medical professional, andthe medical treatment database may include medical treatment information that is accessible to the physician.
A server could be integrated in the system to communicate with the global network of communication. A recording system may be installed on the server to keep records of medical procedures chosen by the doctor. The recording system could monitor the medical procedures selected by the physician to ensure compliance with a predetermined standard selected from a plurality of standards that have been established. The recording system advantageously enhances training of medical professionals, which improves the quality of medical treatment given to patients, through reducing the chance of medical errors.
The system can also comprise the standards database that communicates with the global communications network. The database for standards may contain the variety of standards that have been predetermined and is able to be upgraded. The plurality of predeterminedstandards may, for example, be hospital standards, insurance standards, medical treatment standards, pharmaceutical standards, medical office standards, or emergency response standards. The system can integrate practice guidelines from a variety of sources such as federal programs, insurance companies, hospitals, and other medical facilities, as well as medical practices and specialists.
In the same way, patient information, diagnosis, as well as medical treatment databases could also be updateable. The databases can be upgraded in a way that provides doctors with the most up-to-date medical information , and enhances the quality of medical care.
The system may also include a reporting system for reporting medical professionals who have chosen an option for medical treatment that is not in compliance with at least one of the plurality of predetermined standards in the standards database. Medical professionals could be, for instance, reported to an agency for reporting. The reporting system can increase the capacity of the system to supervise medical professionals who repeatedly choose treatments that aren’t conforming to predetermined standards. Medical professionals who are not in compliance could be recommended training by the monitoring system.
An identification device for medical professionals can be integrated into the system to identify the doctors who have access to the databases. The system may also include a notification system in communication with the global communicationsnetwork for notifying an insurance company of patient treatment. The notification system could advantageously reduce the time medical professionals receive reimbursement from insurance companies for medical treatments that they recommend to patients.
The medical professional could include, for instance, an ophthalmologist, physician assistant, a nurse or pharmacist, a dietician, laboratory technician, or an emergency response worker. The system can be easily adapted to be used by any medicalprofessional that has interaction with patients.
The monitoring of a doctor is a component of the invention. The method can include providing the medical professional access to the patient database, the diagnosis database, and the medical treatmentdatabase. The method could also involve monitoring the medical treatment selected by the physician for the compliance with a minimum of one predetermined standard selected from a variety of standards that have been predetermined on the standards database that is predetermined.
Another aspect of the present invention is for choosing a treatment for medical use. The method could include accessing and updating the patient information of a registered patient in an information database for patients and then accessing the diagnosis information in the diagnosis database and deciding on the appropriate medical treatment for the patient based on the information about the diagnosis contained within the database for diagnosis. This method could also include the evaluation of the chosen medical treatment in relation to existing medicaltreatment.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)” that are programs that are integral (embedded inside) medical device.
Section 201(h),?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, device machines, devices, implant an in vitro regulator or any other similar or similar items, as well as a component or accessory. . . (b) designed for use for the diagnosis of diseases or other conditions, or in the cure, mitigation, treatment, or prevention of diseases in man or other animals, or (c) designed to alter the structure or the function of the human body or other animals.? Thus, to be considered a medical device and therefore subject to FDA regulations, your software must satisfy one of two criteria:
- It must be designed for use in diagnosing or treating patients; or
- It must be intended to affect the structure or perform any purpose of the body.
Therefore, if your program is designed specifically for health professionals to diagnose and treat patients, or in hospitals to handle patient records, the FDA is likely to view the software as medical devices subject to regulatory scrutiny.
Is Your Software a Medical Device?
FDA’s current supervision is based on the capabilities of the software, not the platform is designed to ensure that FDA regulates to only devices that have capabilities that pose a risk for patient safety. Examples of Device Software and Mobile Medical Apps that FDA is focused on includes
- Software functions that help those suffering from mental illness (e.g. depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) through the “Skill of the day” behavior technique, or audio messages, which the user is able to access when suffering from anxiety.
- Software functions that provide periodic education information, reminders or motivational guidance for smokers seeking to quit, addicts who are recovering from addiction or pregnancies women;
- Software functions that use GPS location data to alert asthmatics when they’re near areas of high risk (substance users) and to inform them of potential environmental conditions that may trigger symptoms.
- Software that uses games and video to help people to do their take part in exercise at home.
- Software functions that require a user to enter the drug and herb they would like to take in conjunction and offer information on whether interactions have been seen in the literature as well as an explanation of what kind of interaction was reported;
- Software functions that take into account the characteristics of patients, like gender age, gender, as well as risk factors, in order to provide patient-specific counseling, screening, and prevention recommendations from established and well-respected authorities.
- Software functions that use an inventory of typical symptoms and signs to give information on when to visit an ophthalmologist and what to do next.
- Software functions allow users to complete a questionnaire about symptoms and to make a recommendation on the best type of healthcare facility for them.
- Mobile apps are designed to enable users to make a pre-determined emergency or nurse call using broadband or mobile phone technology;
- Apps that allow caregivers or patients to communicate emergency alerts to first responders through mobile phones
- Software that tracks medications and gives user-configured reminders that increase the adherence to medication.
- Software functions allow users access to their health data. This includes historical trending as well as comparisons of vital signs (e.g. body temperature, heart rate or blood pressure).
- Software functions that display trends in personal healthcare incidents (e.g. hospitalization rates or alert notification rate)
- Software functions that allow a user to collect (electronically or manually entered) blood pressure information and share this data through e-mail as well as track and track it, or add it into a personal or electronic health record.
- Mobile apps that provide oral health reminders or monitoring tools for people suffering from gum disease;
- Mobile apps that offer patients with prediabetes guidance or tools to help them improve their eating habits, or to increase physical activity
- Applications that permit users to display messages and images on smartphones, which could be utilized by addicts looking to stop their addiction.
- Software functions that provide drug-drug interactions and relevant information about safety (side effects and drug interactions, active ingredient) in a report based on demographic information (age, gender) and medical information (current diagnosis) and the current medication as well as
- Software functions give the surgeon a list of recommended intraocular lens strengths and the recommended axis of implantation based on information supplied by the surgeon (e.g. the anticipated surgically induced astigmatism, patient’s axial length and corneal astigmatism before surgery, etc.)
- Mobile apps, typically software, converts a mobile platform into a medical device which is regulated.
- Software that can be connected to a mobile device using a sensor or a lead to monitor and display the electrical signals generated by the heart (electrocardiograph, ECG).
- Software that connects a sensor or other device to the mobile platform in order to monitor eye movements in order to identify balance issues.
- Software that gathers information about potential donors and sends the information to a blood collection facility. This software is used to determine if a potential donor is qualified to donate blood or any other component.
- Software that connects with an existing device to regulate its operation, function or energy source.
- Software that changes the settings or function of an infusion pump
- Software that controls the deflation or inflation of the blood pressure Cuff
- Software that is used to calibrate hearing devices and evaluate the electroacoustic frequency, sound intensity characteristics, and coming 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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