United Services Automobile Association (USAA) (San Antonio, TX)
What is a Software Medical Device for Systems and methods for automating the process of processing payments
Customers expect more from the products and services they use more than they have ever. They insist that the organizations they deal with regularly provide them greater and greater amounts of information and accessibility. These companies are creating and operating more complex systems capable of providing highly integrated services to customers.
For instance, a client who has an insurance plan with a company that will cover their car is expected to receive quick resolutions when they are injured in an accident. Lengthy processing times and numerous conversations between the customerand the business could lead to losing a customer. Each auto accident or loss is unique, and therefore demands a different level of focus. The fact that auto accidents are a part of life is of little consequence to the consumer who has an allowance for the thousands of insurance claims that may be processing at the same time in the same way as their own. They are faced with a lengthy process with no satisfaction, and very little satisfaction during the most difficult period of their lives.
In one embodiment the apparatus for providing automated payment services includes one or more data stores, a rules engine to process one or more rules related to loss as well as an audit engine to provide an audit function and a payment engine. Additional embodiments can include a medical claim processor that can provide audit functions for first-party medical losses. Another embodiment of the engine for rules can be configured to extract context from the information for rules processing.
A method of making loss-related payments could involve receiving a notification, deriving the payer, processing up to five rules, and determining if an automated payment is made, and then transferring funds, if feasible. A further embodiment of the process of determining a payee is determining the amount of coverage and the liability for the loss, as well as determining one if the beneficiary is at least one of the entities.
In an example, a method of processing payments for a loss includes receiving a notice of loss and determining each of the exposures, and processing, in parallel, one or more rules, determining if an automatic payment is made, and removing anexposure from automatic payment, while processing the payments for the remaining exposures.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA could refer to functions in software, which include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)” These are applications that are integrated (embedded within) medical device.
Section 201(h),?21 U.S.C. 321(h),(1) defines medical devices as apparatus, instrument, machine, contrivances, implant an in vitro regulator or other similar or related articles and an accessory or component. . . (b) designed for use to diagnose diseases or other conditions, or for the treatment, mitigation, treatment, or prevention of disease in animals or man or (c) designed to alter the structure or the functions of the body of man or any animal.? Therefore, in order to be considered a medical device and therefore subject to FDA regulation, your program must satisfy one of two requirements:
- It must be intended to aid in diagnosing or treating patients.
- It must not be designed to alter the structure or the function of the body.
If your program is intended to be utilized by health professionals to diagnose, treat or manage patient data in hospitals, the FDA will likely consider such software to be medical devices and subject to regulatory review.
Is Your Software a Medical Device?
FDA’s current oversight, which puts greater emphasis on the capabilities of the software than the platform, will ensure that FDA is not regulating medical devices with functions that pose danger to patient safety. Examples of Device Software and Mobile Medical Apps FDA is focused on
- Software functions that help patients with diagnosed mental disorders (e.g., anxiety, depression, post-traumatic stress disorder (PTSD), etc.) by offering “Skill of the Day”, a behavioral technique, or audio messages, that the user can access at any time they feel more anxious.
- Software functions that offer periodic educational information, reminders, or motivational guidance to smokers who want to quit, patients who are recovering from addiction and pregnant women;
- Software functions that utilize GPS location data to alert asthmatics when they are in high-risk areas (substance abusers) or to warn them to environmental conditions that could cause symptoms.
- Software functions that make use of video games and videos to encourage patients to perform their physical therapy exercises at home;
- Software functions that prompt the user to input which herb and drug they’d like to use concurrently and provide information about whether interactions have been observed in the literature and an overview of the type of interaction was reported;
- Software functions that take into account specific characteristics of patients, such as gender, age, and risk factors, to provide specific counseling, screening and prevention recommendations from established and well-respected experts.
- Software functions that utilize an inventory of typical signs and symptoms to provide information on when to visit an ophthalmologist and what next.
- Software functions that help users to answer a survey about their symptoms and then provide a recommendation of the best type of medical facility to treat their needs.
- Mobile applications that are designed to enable users to initiate a pre-specified nurse call or emergency call using broadband or cellular phone technology.
- Mobile apps that allow a patient or caregiver to design and send an alert or general emergency message to emergency personnel;
- Software functions that keep track of medication and offer the user with a customized reminder system to help improve medication adherence;
- Software functions give patients access to their health records. This can include historical trends as well as comparisons of vital signs (e.g. body temperature, heart rate or blood pressure).
- Software features that combine and display trends in personal health incidents (e.g., rate of hospitalization or alert rates of notification);
- Software functions let users either manually or electronically enter blood pressure information, to share it with e-mail as well as track and track it, then upload it into your personal or electronic health record.
- Mobile apps that provide reminders about oral health or tracking tools for users with gum disease.
- Apps that offer mobile guidance and aids for prediabetes patients;
- Apps that let users display pictures and other messages on their smartphones, which can be used by users of drugs who wish to end their addiction.
- Software functions that offer drug-drug interactions as well as pertinent information about safety (side effects, drug interactions, active ingredient) in a form of a report, that is based on demographic information (age, gender), medical information (current diagnosis) and the current medication and
- Software functions that give the surgeon the list of suggested intraocular lens power and suggested an axis for implantation based upon the information provided by the surgeon (e.g. an predicted surgically induced astigmatism patient’s axial length and corneal astigmatism before surgery, etc.)
- Mobile apps, typically software, converts a mobile platform into a regulated medical device.
- Software that is connected to mobile platforms using a sensor or a lead to monitor and display the electrical signals generated by the heart (electrocardiograph, ECG).
- Software that connects sensors to the mobile platform or other tools in the platform, that allow users to see the eye movements, record and analyze the eye movements in order to detect balance disorders
- Software that gathers information about potential donors and sends the data to a blood collection facility. This program is used to determine if a potential donor is eligible before collecting blood or any other component.
- Software that connects to an existing device to control the device’s operation, function or power source.
- Software that alters or deactivates the functions of an infusion pumps
- Software that regulates the inflation or deflation of a blood pressure Cuff
- Software that is used to calibrate hearing devices and assess the electroacoustic frequency, sound intensity characteristics, and coming from 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.
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