Fujitsu Limited (Kawasaki, JP)
What is a Software Medical Device for Queries-and-responses processing method, queries-and-responses processing program, queries-and-responses processing program recording medium, and queries-and-responses processing apparatus
1. Field of the Invention
The present invention is a technique for query and response processing for querying a database using natural language. It gives details about a person or thing within the database. Then, it presents the data to the user.
2. Description of the Prior Art
A variety of systems that are able to receive requests for data from a database and present a corresponding entry or data processed by processing the entry have been developed in laboratories and described in many papers
The systems are able to take on questions such as “How is the Eiffel Tower’s height?” Or “What nationality was the winner of the Lillehammer Winter Olympic Games giant slalom?” These questions are clear and may yield only a few answers.
However, search engines that use text will produce more results. They are ambiguous and sometimes yield a huge number of results that make it difficult to judge their relevance. For example, if technologies relating to a particular technology are searched for in a huge number of patent documents, it’s difficult to give a one-stop solution to the question. Therefore technologies used in the traditional systems for answering queries are not able to be utilized in cases where a query may yield variousanswers.
A search that is based on text is, in practice, not a simple request and response. The information to be extracted may be inconclusive, and can yield numerous results that make it difficult to know if they’re suitable. Therefore if unprocessed search results are displayed to users in a conventional device, the user has to perform a number of tasks such as the selection and extraction of required information.
With these challenges in view of these issues, it is the object of the present invention to examine the purpose of a query provided by a user, in order to reduce search result information to a level that is manageable for the user, then sort out the result information, and present itin an easily readable form to the user by selecting the desired information.
To achieve the object, the present invention is a method of processing queries and responses for receiving a search request which is a query submitted by a user, and then searching databases to display search results to the user that includes the steps of analyzing the search request provided by the user, generating search criteria based on the result of the search request analysis, and using the database to search in accordance to the search criteria. The principal features of the invention are the analysis of the purpose of the query, based on the analysis of the search request. It also includes the selection of the items that are presented to the user from the search results.
The intent of the query made by the user may be determined by locating the most important subject of the query and then selecting main items concerning the key topic and things that relate to the primary items as items to be included in the results of the search.
A computer and a program can be used to execute the above procedure. The program can be stored on an appropriate recording media, like memory that is portable, semiconductor memory, or hard disks that are read by the computer.Click here to view the patent on USPTO website.
Get Patents with PatentPC
What is a software medical device?
The FDA refers to functions in software that can include ” Software as a Medical Device” (SaMD) as well as “Software in Medical Device (SiMD) ), which is software that is integral to (embedded in) the medical device.
Section 201(h),?21 U.S.C. 321(h),(1) defines medical devices as apparatus, device or devices, a machine, an implant an in vitro regulator or other similar or related articles in addition to a component or accessory. . . (b) designed for use to diagnose illnesses or other conditions or for the cure or treatment or prevention of diseases for animals or humans or (c) is designed to alter the structure or any functions of the body of man or any other animal.? So, to be considered a medical device , and consequently subject to FDA regulation, your program must meet one of two criteria:
- It must be used in diagnosing and treating patients.
- It must not be designed to alter the structure or the function of the body.
So, if your application is designed specifically for health professionals to diagnose and treat patients, or is used in hospitals to manage patient information and patient information, the FDA would likely view such programs as medical devices subject to regulatory review.
Is Your Software a Medical Device?
FDA’s current oversight, which looks at functionality more than platform, will ensure that FDA uses its oversight to only devices for medical use that have capabilities that pose risks to the safety of patients. Examples of Device Software and Mobile Medical Apps FDA is focused on
- Software functions that help those suffering from mental illness (e.g. depression, anxiety, post-traumatic stress disorder (PTSD) for instance.) by providing “Skill of the Day”, a behavioral technique or audio message that the user can access when they are suffering from anxiety.
- Software functions that provide regular reminders, motivational guidance, and educational information to those recovering from addiction or smokers looking to quit;
- Software functions that make use of GPS location information to notify asthmatics when they’re near high-risk locations (substance abusers) or inform asthmatics to circumstances that might trigger symptoms.
- Software functions that use video and video games to motivate patients to do their physical therapy exercises at home;
- Software functions that allow users to select which medication or herb they would like to consume simultaneously. They also provide information on interactions and provide an overview of the type of interaction.
- Software functions that make use of factors that affect the health of a patient, such as age, sex and risk factors for behavioral health to offer specific screening for patients as well as preventive counseling from well-known and established authorities;
- Software functions that make use of a list of common symptoms and signs to provide information on when to visit an ophthalmologist and what you should do next.
- Software functions help patients to answer a survey regarding symptoms and provide a recommendation of the best health care facility for them.
- Mobile apps are designed to allow a user to initiate a nurse call or emergency call using broadband or mobile phone technology.
- Mobile apps that allow the patient or caregiver to design and send an alarm or general emergency alert to first responders.
- Software functions that track the use of medicines and give users user-defined reminders to help improve drug adherence
- Software functions that offer patients with access to their own health data including access to information captured during a previous clinical visit or historical trends, and comparison of vital signs (e.g. body temperature, blood pressure, heart rate, or respiration rate);
- Software features that combine and show patterns of personal health events (e.g. rate of hospitalization or alert notification);
- Software functions allow users to gather (electronically or manually input) blood pressure data , and send this information via email, track and analyze it, or upload it to an electronic or personal health record.
- Apps that provide mobile applications for tracking and reminders of oral health, or devices to monitor users who suffer from gum disease.
- Mobile apps that offer patients suffering from prediabetes with advice or tools to help them develop better eating habits, or to increase physical activity;
- Applications that permit users to display images and other messages on mobile devices, that can be utilized by addicts looking to end their addiction.
- Software functions that give information about safety and interactions with drugs (side reactions and interactions with drugs, active ingredient, active ingredient) in reports based on the demographics (age and gender) and current diagnosis (current medication) as well as clinical information (current treatments).
- Software functions permit the surgeon to identify the most effective intraocular lens power for the patient, as well as the direction of the implantation. The information is based on surgeon’s inputs (e.g. the expected surgically induced astigmatism and patient’s axial length, prior to surgery cornea astigmatism, etc.).
- Mobile applications, which are typically software transforms mobile platforms into a medical device that can be regulated.
- Software that connects to a mobile device by using a sensor or lead that measures and displays the electrical signals generated by the heart (electrocardiograph, ECG).
- Software that attaches sensors to the mobile platform or any other tool within the platform, in order to monitor or record the eye movements to detect balance disorders
- Software that asks potential donors about their history with donors and records and/or transmits those answers to the blood collection facility. This software determines if a donor is eligible to collect blood or other components.
- Software that is connected to an existing device for control of its operation, function, or energy source.
- Software that modifies or blocks the functions of an infusion pump.
- Software that regulates the inflation or deflation a blood pressure cuff
- Software used to calibrate hearing devices and evaluate the electroacoustic frequencies, audio intensity characteristics, as well as sound quality of hearing aids, master hearing aids, group hearing aids, or auditory trainers in 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.
Patent PC is an intellectual property and business law firm that was built to speed startups. We have internally developed AI tools to assist our patent workflow and to guide us in navigating through government agencies. Our business and patent lawyers are experienced in software, SaaS, and medical device technology. For a flat fee, we offer legal services to startups, businesses, and intellectual property. Our lawyers do not have to track time as there is no hourly billing and no charges for calls or emails. We just focus on getting you the best legal work for your needs.
Our expertise ranges from advising established businesses on regulatory and intellectual property issues to helping startups in their early years. Our lawyers are familiar with helping entrepreneurs and fast-moving companies in need of legal advice regarding company formation, liability, equity issuing, venture financing, IP asset security, infringement resolution, litigation, and equity issuance. For a confidential consultation, contact us at 800-234-3032 or make an appointment here.