Intuit Inc. (Mountain View, CA)
What is a Software Medical Device for Methods and methods for entering positional numbers
Is Your Software a Medical Device for Methods and methods for entering positional numbers
A variety of devices and applications which are used daily require the entry of numbers. Software for recording, financial software (e.g. for maintaining the medical history or logs for industry) as well as calculators and others all require number entry. could require users to enter some or all numbers.Typical number entry might involve entering numbers by pressing the appropriate numbers keys on the sides or the top of a standard keyboard. Therefore, typical number entry might require several strokes to enter a series of numbers. Certain users might prefer a simpler way to enter numbers. Some users may want alternative methods of entry.
A number entry mechanism could be equipped with a motion-sensitive input device that can detect the user’s movements in two dimensions. The motion-sensitive input device could comprise an input device such as atouchpad, touchscreen computer mouse, etc. that receives an input in a direction from the user. A number entry mechanism can also comprise an internal memory medium, as well as instructions and programs that permit the calculation of numerical inputs from the received directioninput. The numerical inputs could be determined using the magnitude of the motion in either of the two dimensions, based on the particular embodiment. In some embodiments, the number entry mechanism may comprise a memory media and program instructionsresident on the motion sensing input device, or as part of an independent device.
Some embodiments include motion in the X and Y directions. The directional input received could also comprise the determination of a Y position at some or all intervals during the X motion. The Y location could indicate anumber (e.g. between 0-9) while the X interval could represent the numerical position of the number. Certain embodiments of motion sensitive input devices and/or display devices coupled to them could include labels along the grid that provide numerical values (e.g. along the direction of Y) or labels that indicate numerical placement (e.g. in the direction of X). The grid and/or the labels could help users input. In some instances, the motion sensitive input device mayinclude some or all protrusions to identify one or more of a numerical placement or number.
Certain embodiments could also include lines drawn using fingers or stylus against the motion sensing input devices. The motion-sensitive input device could also take input from a user that indicates the presence of one or more of the symbols (e.g.,a user’s tap on a bar in the direction of X or Y). In some instances, computer programs can be run to identify symbols or other non-numerical inputs automatically in response to input from a user. For instance the user could tap on a bar in either X or Y direction.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA is referring to the functions of software that can include ” Software as a Medical Device” (SaMD) and “Software in a Medical Device (SiMD) ), which is software that is part of (embedded in) the medical device.
Section 201(h),?21 U.S.C. 321(h)(1) defines a medical device as ?an instrument, apparatus, instrument, machine, contrivance implant, in vitro reagent, or other similar or related device, such as accessories or components that is . . . (b) is designed for diagnosis or treatment of illnesses or other conditions that affect humans or animals. (c) Is intended to modify the structure or functions of animals or human bodies. Therefore, in order to be classified as a medical device and therefore subject to FDA regulations, your software must satisfy one of two criteria:
- It should be used for diagnosing and treating patients.
- It should not be designed to alter the structure or the function of the body.
Thus, if your software is specifically designed for healthcare professionals to treat and diagnose patients, or is used in hospitals for the management of patient data The FDA will likely consider such programs as medical devices that are subject to review by the regulatory authorities.
Is Your Software a Medical Device?
In accordance with FDA’s current approach to oversight, which considers the functionality of the software more than its platform, FDA will apply its regulation only to medical devices with functions that cause harm to patient safety. Examples of Device Software and Mobile Medical Apps FDA is focused on
- Software functions that aid patients with diagnosed psychiatric conditions (e.g. post-traumatic stress disorder (PTSD), depression, anxiety, obsessive compulsive disorder) maintain their behavioral ability to cope by offering a “Skill of the Day” behavior technique or audio-based messages the user can use when they are experiencing an increase in anxiety;
- Software functions that offer periodic reminders, motivational support as well as educational information for those recovering from addiction or smokers who wish to stop.
- Software functions that utilize GPS location information to alert asthmatics of environmental conditions that may cause asthma symptoms, or to alert an addiction patient (substance addicts) in proximity to a specified high-risk area;
- Software functions that make use of video and video games to inspire patients to perform their physical therapy exercises at home;
- Software functions that prompt the user to input the herb or drug they would like to take concurrently and provide information about whether interactions have been observed in the literature, as well as an overview of the type of interaction was described;
- Software functions that are able to take into consideration the characteristics of the patient, like gender, age, and risk factors, in order to provide patient-specific counseling, screening, and prevention recommendations from established and respected authorities.
- Software functions that use a checklist of common signs and symptoms to provide a list of possible medical conditions , as well as advice on when to see the health professional;
- Software functions that help users to complete a questionnaire about symptoms and to provide a recommendation of the most appropriate healthcare facility for them.
- These mobile applications allow users to make pre-defined nurse calls as well as emergency calls with the internet or cell phone technology.
- Mobile applications that permit patients or their caregivers to create and send an alert or general emergency notification to first responders;
- Software functions that track the use of medicines and give users user-configured reminders for improved drug adherence
- Software functions that provide patients a portal into their personal health information including access to the information gathered during a previous clinical visit or historical trending and comparison of vital signs (e.g., body temperature, heart rate, blood pressure or respiratory rate);
- Software functions that display patterns in personal health incidents (e.g. hospitalization rates or alert notification rates)
- Software functions that allow users to gather (electronically or manually entered) blood pressure data and send this information via e-mail, track and trend it, or add it into a personal or electronic health record.
- Mobile apps that provide oral health reminders or tracking tools for users with gum disease.
- Apps that offer mobile guidance and aids for patients suffering from prediabetes;
- Mobile apps that show, at opportune times images or other messages for an addict who is trying to stop addictive behavior;
- Software functions that report safety and drug interaction information (side effects and drug interactions, active ingredient, active ingredient) in an analysis based on the demographics (age and gender), current diagnosis (current medications), and clinical information (current treatments).
- Software functions allow the surgeon to identify the best intraocular lens powers for the patient as well as the axis of implantation. This information is based on the surgeon’s inputs (e.g. the expected surgically-induced astigmatism, length of the patient’s axial axis, preoperative corneal astigmatism etc.).
- Mobile apps, usually software which transforms mobile platforms into a regulated medical device.
- Software that communicates with an mobile platform using a sensor or lead to display and measure electrical signals from the heart (electrocardiograph; ECG).
- Software that attaches an eye sensor to the mobile platform or any other tool within the platform, to view or record the eye movements to diagnose balance disorders
- Software that asks potential donors about their donor history and their records and transmits those answers to the blood collection facility. The software can determine whether a person is eligible to collect blood or any other component.
- Software that connects with the device’s type in order to regulate its operation, function or energy source.
- Software that changes the functions or settings of an infusion pump.
- Software that regulates the inflation or deflation of the blood pressure cuff
- Software is used to calibrate hearing devices and assess the electroacoustic frequencyand the characteristics of sound intensity, and sound quality of 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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