International Business Machines Corporation (Armonk, NY)
What is a Software Medical Device for To improve user feedback to improve user feedback, specify the default value for a property
1. Field of the Invention
The invention described hereinafter is suitable for feedback from users in a graphical interface and, in particular, to a method and system to indicate default values for properties of objects within a graphic user interface.
2. Description of background
A graphic user interface, also known as a GUT is used to organize the interaction between a user (or computer system) and a program. It is an application (or collection of programs) which acts as an overlay for the operating system. A GUT typically employsgraphical icons, visual indicators or special graphical elements called “widgets” or controls together with text labels, or text navigation, to represent the actions and information accessible to users. The actions are typically performed through directmanipulation of the graphical elements. The interfaces are an easy and natural method for users to work with files software, programs, and other utilities within a modern computer system without requiring users to input complicated commands.
Property viewers are a GUI component that shows the properties, attributes or other details of an object, or an arrangement, of data. It is sometimes called an attribute viewer or details viewer. A property viewer is a table which displays every object. The type of the input object determines what properties are displayed. A typical table will have two columns. The first column contains the name of the property while the second column lists the current values of properties that are not being used. Property viewer is a program which allows you to modify the properties of objects.
A default is a setting or value that is automatically assigned to the property of an object, prior to or outside of the control of the user. By establishing objects using common or usable settings, default values make software simpler to use “out out of the box”. In a typical software package the default values for the properties of an object will be set to the most frequently used choices to limit user interaction. Additionally, certain software programs require that default values be supplied. An application will generally make use of specific GUI elements, like property viewers, which allow users to modify property information and change default settings. They can also change the assignedvalue. Property viewers can also provide a user with the option of making properties that have user-set values to reset or return to their default settings.
However, using defaults is likely to cause more errors, as users may select incorrect default settings. The inventors of this invention have noticed that this is particularly a problem when a user is not aware of whether the current property value is either a default value or user-set value or the value assigned as the default value in the event that the property’s value is set by the user. For example, if the user is not familiar with the default value for an item with a user-set value andthe user triggers the property to change to its default value, the default value for the property isn’t known to the user prior to the conversion. If the user was expecting the default setting to have something different it is possible for the user to have the propertyreturn to the previous user-set value. The value that was previously set, however, may be erased during the default reversion so the prior setting is lost if the user does not remember the specific value.
The inventors in this document have identified a requirement to provide feedback on the default values of objects’ properties to the user of a GUI component that permits users to alter the property information of an object.
Examples of the present invention pertain to a method for indicating the default value of the property of an object to the user of an interface for graphical users (GUI) of a software module. The property could have a value or the state can be altered. The state of the property can be set to the default states and the user-set state. If the default state is selected then the default value is given to the property. The system consists of the GUI control having first, second, and thirdinterface elements. The first interface element is designed to indicate what the property’s value is to the user. The second element of the interface indicates the status of the property. The third element of the interface is designed to display the default value for the property to the user when the property is set by the user. state.
Exemplary embodiments of the present invention also relate to computer programs and method products corresponding to the above-summarized system.
Read the description and the drawings for a better understanding about the examples of embodiments and their advantages and characteristics.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA refers to software functions that can include ” Software as a Medical Device” (SaMD) as well as “Software in a Medical Device (SiMD) ), which is software that is integrated into (embedded in) the medical device.
Section 201(h) of the Federal Food Cosmetic, Drug, and Act, ?21 U.S.C. 321(h)(1) defines an medical device as an instrument, apparatus, implement or device, machine, implant, in vitro reagent, or any other similar or related item, which includes an accessory or component which includes . . . (b) designed for use to diagnose illnesses or other conditions or for the cure or mitigation of disease, or prevention of diseases in man or other animals or (c) designed to alter the structure or any functions of the body of man or other animals.? To be classified as a medical device and thus subject to FDA regulations the software must meet the minimum of these conditions:
- It should be designed for use in diagnosing or treating patients; or
- It must be intended to affect the structure or purpose of the body.
If the software you use is designed to be utilized by health professionals to diagnose, treat, or manage patient information in hospitals or other healthcare facilities, the FDA will likely view such software to be medical devices that are subject to review under the regulations.
Is Your Software a Medical Device?
As per FDA’s current approach to oversight that considers the function of the software more than its device’s platform, FDA will apply its regulation only to devices for medical use that possess functionality that could be a risk to patient safety. Some examples of Device Software and Mobile Medical Apps that FDA is focusing on include
- Software functions that help those suffering from mental illness (e.g. depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) through the use of “Skill of the Day” or a behavioral strategy or audio message that users can access when they are suffering from anxiety.
- Software functions provide regular educational information, reminders, or motivational tips for smokers who want to quit, recovering from addiction, or pregnancies women;
- Software functions that utilize GPS location data to alert asthmatics when they are near high-risk locations (substance abusers) and to inform asthmatics to possible environmental conditions that could cause symptoms.
- Software that utilizes video and games to encourage patients to take part in exercise at home.
- Software functions that prompt users to select the drug and herb they would like to take simultaneously and give information on whether interactions have been observed in the literature and a summary of what type of interaction was observed;
- Software functions that consider specific characteristics of patients, such as gender age, gender, as well as risk factors, to provide individual counseling, screening and prevention advice from well-established and highly-respected experts.
- Software functions that make use of a list of typical symptoms and signs to give the possibility of medical conditions , as well as advice on when it is appropriate to speak with a health care provider;
- Software functions help patients to navigate through a questionnaire about symptoms and to make a recommendation on the best type of health care facility for the patient.
- The mobile apps enable users to make nurse calls or emergency calls using broadband or cell phone technology.
- Apps that allow caregivers or patients to send emergency notifications to first responders through mobile phones
- Software functions that keep track of medicines and give users user-defined reminders to improve compliance with medication;
- Software functions that give patients with a way to access their own health information, such as access to the information gathered during a prior visit to a doctor or historical trends and comparison of vital signs (e.g., body temperature or blood pressure, heart rate or respiratory rate);
- Software functions that aggregate and show patterns in health-related incidents that affect individuals (e.g., alert notification rates or hospitalization rates);
- Software tools let users manually or electronically enter blood pressure information, to share it via e-mail, track it and trend it, and upload it into your personal or electronic health record.
- Apps that provide mobile applications for tracking and reminders about oral health , as well as tools to track users who suffer from gum disease.
- Apps that give mobile users access to information and tools for prediabetes patients;
- Mobile applications that display when appropriate, images or other messages for those who abuse substances and want to end their addiction;
- Software functions that report information on safety and drug interactions (side effects and drug interactions active ingredient active ingredient) in reports based on information about demographics (age and gender), current diagnosis (current medications) as well as clinical information (current treatment).
- Software functions allow surgeons to identify the most effective intraocular lens power for the patient and the direction of the implantation. This information is determined by the surgeon’s inputs (e.g., expected surgically-induced astigmatism, patient’s axial length, preoperative cornea astigmatism, and so on.).
- Applications, mostly mobile, that transforms a mobile platform into an approved medical device.
- Software that communicates with an mobile platform using an instrument or lead to measure and display electrical signals coming from the heart (electrocardiograph; ECG).
- Software that attaches sensors or other devices to the mobile device in order to monitor, record and analyze eye movements to identify balance issues
- Software that collects information about potential donors and sends the information to a blood collection facility. This program is used to determine if a potential donor is eligible before collecting blood or other components.
- Software that is connected to an existing device to control the device’s operation, function or energy source.
- Software that modifies or disables the functions of an infusion pump.
- Software that regulates the inflation or deflation a blood pressure cuff
- Software to calibrate hearing devices and analyzes the sound characteristics and electroacoustic frequencies of hearing aids, master hearing aids, and hearing aids that are group-based.
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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