What is a Software Medical Device for Interactive protocols and methods are an integral part of the medical decision system
Is Your Software a Medical Device for Interactive protocols and methods are an integral part of the medical decision system
Software and systems are widely used by medical professionals to assess patient conditions and prescribe specific medical treatment.
A medical system is an example. It was developed by the department of Accident and Emergency of Westminster Hospital in London. The system provides advice on how to manage chest pain patients in emergency rooms. A second system for medical information is accessible under the trade name “ADE Monitor”. It is currently being developed at Washington University School of Medicine, Division of Medical Informatics. The system was designed to track patient data for adverse drug interactions that could be a possibility. A like medical system is available 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 section of Rheumatology is also included. It 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 by Drazen describes a system that comprises a database for storage of a range of medical guidelines for different health conditions, and also for storing historical patient informationdata for a range of patients. The information about the patient is collected over a global communications network, i.e., the Internet and then analyzed to provide a patient specific risk report based upon the medical guidelines stored within the database. Based on the medical guidelines that a doctor may develop an treatment plan that reduces the risk of a patient.
This method, however, can be a disadvantage since it permits a doctor to become reliant upon the system instead of the doctor’s own knowledge of medicine. This system does not monitor the performance of the doctor to assess if the medical treatment is appropriate. This could result in a loss of resources.
U.S. Published Patent Application No. 2002/0143579 by Docherty and colleagues. discloses a system that identifies the potential for direct intervention by physicians to enhance prescribing practices and ensure compliance of patients. The system gathers information on the practices of a physician, and examines it in relation to the guidelines of an expert. The system identifies deviations from the guidelines of experts and gives the doctor intervention information.
U.S. Pat. discloses an assessment system for physician performance, which includes a database that stores physician/patient contact. No. 5,924,073 to Tyuluman et al. A evaluator is connected to the database in order to analyze the data by using statistical analysis. This method can be utilized to determine the standard of care for the specific patients. The standard of care could be updated based upon better and more efficient treatments and also find doctors who do not meet the prescribed guidelines of care. However, these systems do not consider the several standards that a physician must analyze when prescribing medical treatment, i.e., hospital standards, medical standards, insurance standards, etc.
U.S. Published Patent Application No. 2003/0055679 by Soil et al. provides a computerized management of patients system that includes the patient module and a physician module and a database. Patients can input their patient details in the module for patients. The database holds information about medical assessment and treatment that is used to evaluate the patient’s information and create a report. The report can be edited by the doctor to include assessment and management plans. The doctor can also decide on educational materials to present to the patient with a health summary at the time of a patient interview. This system is heavily dependent on the patient’ ability to properly input their personal information.Further the system gives access to persons that don’t have as much knowledge of medicine as a medical professional.
U.S. Pat. No. 5,924,074 from Evans is directed to a medical records system that manages and creates patient data electronically. The interface is graphic and includes touchscreens. The system captures patient data like patient complaints, lab orders medication, diagnoses and other procedures. It allows medical professionals to access a pen-based portable computer that is connected wirelessly to a computer networked to review, analyze, or make changes, and electronic annotations of patient data.
U.S. Pat. No. No. The processor generates an examination report for the patient, which includes a possible diagnosis. The Joao ‘761 patent reveals providing access to healthcare providers as well as patients and insurance companies in order that the correct updates to patient information may be done. The system can be utilized to allow a medical professional to establish the medical diagnosis, confirm the diagnosis or treatment or treatment, or permit patients to conduct self-diagnosis. The Joao patent also reveals the method of offering continuing education and training services to medical providers that are delivered electronically.
One issue with the system described above is that it may be required to enter duplicate data. Medical professionals generally adhere to various protocols depending on a presumed diagnosis. In different protocols, there could be a need to provide duplicate information based on various medical observations. Medical professionals may perform an initial examination and then modify the diagnosis. In the event of a change in protocol, it may be necessary for the medical professional to enter medical or observational information that are duplicate. Of course, such duplicative activity is a strain on the already tight schedules of medical professionals. Medical protocols that are not included in the initial list may not be available to the medical professional making adjustments to a diagnosis or additional observations are taken. In this scenario, the medical professional may need to look in a different database to locate the latest protocol. This can be a disadvantage for the medical professional because it limits the medical professional’s ability to spend their time.
The invention described herein is a protocol-based interactive system and method that allows users to gain access to different medical protocols. The invention also seeks to create an interactive protocol system that permits doctors to swiftly get information on medical practices. This reduces errors. The present invention also intends to create an interoperable protocol system that minimizes duplicate entries and is efficient.
These and other items that are features, advantages and other objects according to the present invention are offered by an interactive protocol system comprising numerous medical-related databases that include medical information as well as rules for medical care. A protocol that is interactive can also contain a patient database that contains information about patients, and a database containing details on medical procedures.
The interactive protocol may further include a questions database including questions to be presented to the user regarding medical care, and an answers database that contains answers that relate to the questions in the questionsdatabase. The multitude of medical information databases, such as the patient information database, the medical practice database, the database for questions and the answers database are typically stored on a computer readable media or in a computer memory. The databases can be accessed by the user through the user interface.
The medical practices database also is ideally comprised of a number of protocols. Each of the plurality of protocols comes with a variety of questions with narrowing options to be presented to the user. Based on the answers supplied by the user, questions that are related to the various protocols will be presented to them. The questions that are narrower in every one of the protocols are to be answered by the user to provide the user an indication of medical practices. The indication that relates to medical practices could be a diagnosis selected from a range of diagnoses stored on one of the many medical information databases.
The vast array of medical related information databases may include medical analysis information that is used in making a medical decision. The medical related decision may include a prescribed medication, a medical test, a medical procedurerecommendation, a medical treatment recommendation, and an indication relating to insurance reimbursement. The information pertaining to medical practices may provide the user information necessary to make the medically based decision. A signification could be a medical-related decision which is derived from many medical related decisions on one of the databases. The medical-related decision could be based on a comparison of the guidelines stored on one of the medical related databases and the responses to the questions.
The selected medical related decision could represent one of a variety of the best practices. The term “best practice” can be defined as a best medical decision that is verified by at minimum one medical professional peer. Many medical information databases can be utilized to keep up-to-date with best practices. Particularly, the vast majority of medical related information databases may be automatically updated with the most effective techniques.
The user interface permits them to add patient data to the database of patients when they are asked. The interactive protocol system that is based on the invention has the duplication prevention system. This prevents a prompt indication from requiring the user to input patient data already stored in the database of patients. The user may enter information through the interface, which includes medical history information, medication information, and insurance information. The information of the user could be entered into both the medical databases and the patient databases.
The method of the invention described herein is for making a medical-related decision through an interoperable protocol system. This could include asking the user a question about medical care stored in databases. The method may also prompt the user to provide an answer to the question. Another method could be used to decide which of the protocols will be presented to the user based on answers to the questions. The user may also be presented with narrowing questions related to each protocol in the questions database. The method may also comprise giving an indication to the user about medical practices, in accordance with the responses to the narrowing questions.
A further method of the invention is directed at making a medical decision. It involves asking the user a question regarding medical treatment and asking them to respond to the question. This could also mean making a decision about which of the protocols will be presented to the user based on the responses to the questions, and asking the user additional questions related to that protocol. This method can also include the entry of information about a patient into a patient database via the user interface, in response to an indication. This could also stop the presentation of a prompt that requires the input of data about the patient that is already in the patient database.
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What is a software medical device?
The FDA refers to software functions that may comprise ” Software as a Medical Device” (SaMD), and “Software in Medical Device (SiMD) ), which is software that is integrated into (embedded inside) a medical device.
Section 201(h),?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, device, machine, contrivances, implant in vitro regulators, or other similar or related items and an accessory or component. . . (b) is intended to diagnose the presence of disease or other ailments or treat, mitigate, treat, or prevent these. (c) is a device that has the possibility of altering the body’s structure or function. body of other animals. To be considered a medical device, and consequently subject to FDA regulations, the software must meet at least one of these requirements:
- It must be used in the diagnosis and treatment of patients.
- It is not intended to affect the structure or perform any function of the body
Thus, if your software is designed specifically for health professionals to diagnose and treat patients or in hospitals to manage information about patients and patient information, the FDA is likely to view the software as medical devices subject to review by the regulatory authorities.
Is Your Software a Medical Device?
According to FDA’s current oversight approach, which considers the functionality of the software higher than its device’s platform, FDA will apply its regulation only to devices for medical use that possess functions that pose a danger to patient safety. Examples of Device Software and Mobile Medical Apps FDA is focused on
- Software functions to aid patients suffering from diagnosed mental disorders (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) through the use of “Skill of the Day”, a behavioral technique, or audio messages, which the user is able to access when suffering from anxiety.
- Software functions that offer periodic educational information, reminders, or motivational advice to smokers who want to quit, addicts recovering from addiction, and pregnant women;
- Software functions that utilize GPS location information to alert asthmatics of conditions in the environment which could trigger asthma symptoms, or to notify an addict (substance addicts) when near a pre-identified high-risk or high-risk location.
- Software that utilizes video and games to encourage people to do their take part in exercise at home.
- Software functions that require the user to input which herb and drug they’d like to use concurrently and provide information about the likelihood of interactions being reported in the literature and a summary of what type of interaction was described;
- Software functions that are able to take into consideration patient characteristics, such as gender age, gender, as well as risk factors, to provide specific counseling, screening and prevention advice from well-established and highly-respected experts.
- Software functions that make use of a list of common symptoms and symptoms to provide advice about when to see an ophthalmologist and what to do next.
- Software functions allow users to answer a survey about symptoms and to make a recommendation on the most appropriate health care facility for their needs.
- The mobile apps enable users to make nurse calls as well as emergency calls with cell phone or broadband technology.
- Mobile apps that enable the patient or caregiver to create and transmit an alarm or general emergency alert to first responders.
- Software functions keep track of medicines and give users user-configured reminders to help improve drug adherence
- Software functions that offer patients with a way to access their personal health information for example, access to information captured during a previous clinical visit or historical trending and comparison of vital indicators (e.g., body temperature, blood pressure, heart rate, or respiration rate);
- Software functions that display trends in personal healthcare incidents (e.g. rate of hospitalization or alert notification rate)
- Software tools let users electronically or manually enter blood pressure information, to send it to e-mail as well as track and track it, and then upload it into an electronic or personal health record.
- Apps that offer mobile apps to track and remind users about oral health , as well as devices to monitor users suffering from gum disease.
- Apps that provide mobile access and aids for patients suffering from prediabetes;
- Apps that allow users to display pictures and other messages on their smartphones, which can be used by addicts looking to quit addictive behaviors.
- Software functions that provide interactions between drugs and other medications as well as relevant safety data (side effects or drug interactions, active ingredient) as a report based on demographic information (age and gender) and medical information (current diagnosis) and the current medication and
- Software functions allow the surgeon to have a list of recommended intraocular lens power and suggested axis of implantation based on information provided by the surgeon (e.g. the anticipated surgically induced astigmatism, patient’s axial length and cornea astigmatism before surgery, etc.)
- Applications, mostly mobile which converts a mobile platform to an approved medical device.
- Software that connects with an mobile platform using a sensor or lead to measure and display electrical signals from the heart (electrocardiograph; ECG).
- Software that attaches a sensor or other tool to the mobile platform in order to observe, record and analyze eye movements in order to identify balance issues.
- Software that questions potential donors about their history as donors and records , and then transmits the answers to an institution for blood collection. This program is used to determine if a person is eligible before collecting blood or other components.
- Software that is connected to an existing device type for control of the device’s operation, function or power source.
- Software that modifies or deactivates the functions of an infusion pump
- Software that regulates inflation or deflation of a blood pressure cuff
- Software is used to calibrate hearing devices and evaluate the electroacoustic frequencies, sound intensity characteristics, and emanating from hearing aids master hearing aids, hearing aids that are group-based, or group auditory trainers.
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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