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What is a Software Medical Device for Methods and systems to automate payment processing
Is Your Software a Medical Device for Methods and systems to automate payment processing
Customers expect more from the products and services they utilize like never before. They demand that the businesses they work with provide them with greater information and better access. These companies are configuring and running more and more complex systems that are capable of providing high-quality, integrated services to their clients.
For instance, a client who has an insurance contract with a company that will cover their automobile expects to have rapid resolutions when involved in an accident. A customer’s loss could result from lengthy processing time and numerous conversations between the customer and the company. Every auto accident or loss is different and therefore needs to be treated with a specific attention. This aspect of auto accidents does not have any impact on the consumer. They do not make allowances for thousands of insurance claims that are being dealt with simultaneously like their own. The only thing they will experience is a long process with very little satisfaction in a particularly traumatic time in their lives.
An apparatus for providing automated payments could include one or more data stores as well as a rules engine which handles one or more rules related to a lost or stolen item, an audit engine that can provide one or more audit functions, and payment engine. The apparatus may also include additional instances, a medical claim processor to provide audit functions related to first party medical losses. In another way the engine for rules is set up to draw the context of rules processing from the data.
A method of processing loss payments may include receiving a notice, deriving the payer, applying up to five rules, and determining if an automated payment is made, and then transferring funds, if it is possible. A further embodiment of the method of obtaining from a payee involves determining coverage and 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 paying for losses is receiving a loss notice and deriving the respective exposures, processing, in parallel one or more of the rules, determining whether an automatic payment is made, and removing anexposure from automatic payment, while making payments for all other exposures.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA may refer to functions in software, which include ” Software As a Medical Device” and “Software in Medical Device(SiMD)” These are software that is integral (embedded in a) medical device.
Section 201(h) of the?Federal Food Drug and Cosmetic Act ?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, device, machine, contrivances, implant, in vitro regulator, or any other similar or related items and a component or accessory. . . (b) is designed to diagnose or treat diseases or other ailments in humans or animals. (c) Is intended to alter the structure or function of animals or human bodies. To be considered a medical device, and therefore subject to FDA regulations the software must satisfy the minimum of these requirements:
- It should be designed to aid in diagnosing or treating patients; or
- It must not be designed to alter the structure or the function of the body.
If your software is designed to be used by healthcare professionals to diagnose, treat or manage patient data in hospitals or other healthcare facilities, the FDA is likely to consider the software to be medical devices that are subject to review by the regulatory authorities.
Is Your Software a Medical Device?
According to FDA’s current oversight strategy, which considers the functionality of the software, rather than the device’s platform, FDA will apply its supervision only to devices for medical use that possess functionality that could be a risk to the safety of patients. Some examples of Device Software and Mobile Medical Apps FDA is focusing on
- Software functions that help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder (PTSD), anxiety, depression, obsessive compulsive disorder) maintain their behavioral ability to cope by offering the “Skill of the Day” behavioral technique or audio messages that users can use when they are experiencing an increase in anxiety;
- Software functions provide regular education information, reminders or motivational advice for smokers who are trying to quit, patients recovering from addiction, or pregnant women;
- Software functions that use GPS location data to warn asthmatics to environmental conditions that may cause asthma symptoms, or to alert an addiction patient (substance addicts) when near a pre-identified high-risk or high-risk location.
- Software functions that employ video and games in order to entice patients to perform their physical therapy exercises at home;
- Software functions that require a user to enter the herb or drug they wish to take concurrently and provide information about whether interactions have been observed in the literature as well as an explanation of what kind of interaction was reported;
- Software functions that use patient characteristics like age, sex, and behavioral risk factors to offer specific screening for patients as well as preventive counseling from well-known, established experts;
- Software functions that make use of an inventory of the most common signs and offer guidance on when to see a doctor.
- Software functions guide users through a list of symptoms and signs to give a recommendation on the healthcare facility that is best suited to their requirements;
- These mobile apps allow users to make pre-defined nurse calls or emergency calls using the internet or cell phone technology.
- Mobile applications that permit patients or their caregivers to create and send an alarm or general emergency alert to first responders;
- Software functions that keep track of medicines and give users user-configured reminders for improved compliance with medication;
- Software functions that provide patients with a way to access their own health information including access to the information gathered at a previous visit to the doctor or historical trends and comparison of vital signs (e.g., body temperature or heart rate, blood pressure or respiration rate);
- Software functions that show trends in personal healthcare incidents (e.g. rate of hospitalization or alert notification rate)
- Software functions allow a user to collect (electronically or manually entered) blood pressure data , and share this data through e-mail or track and analyze it, or even upload it to a personal or electronic health record.
- Mobile apps that provide oral health reminders or tracking tools for users with gum disease;
- Apps that provide mobile access and other tools for patients with prediabetes;
- Applications that permit users to display pictures and other messages on smartphones, which are a great option for users of drugs who wish to stop their addiction.
- Software functions that give information on safety and drug interactions (side effects and drug interactions, active ingredient, active ingredient) in an analysis based on demographic data (age and gender) and current diagnosis (current medications) as well as clinical information (current treatments).
- Software functions permit the surgeon to determine the most effective intraocular lens power for the patient as well as the orientation of the implant. The data is taken from the surgeon’s inputs (e.g. the expected surgically induced astigmatism and the length of the patient’s axial axis, preoperative corneal astigmatism etc.).
- Mobile apps, usually software that converts a mobile platform to an approved medical device.
- Software that can be connected to a mobile platform with a sensor or lead that is used to monitor and display the electrical signals produced by the heart (electrocardiograph, ECG).
- Software that attaches sensors to the mobile platform or other tools in the platform, in order to monitor, record, and analyze the eye movements in order to detect balance disorders
- Software that questions potential donors about their history with donors and records , and then transmits the answers to a blood collection facility. This program determines the eligibility of a potential donor to donate blood or other components.
- Software that connects to an existing device type in order to control the device’s operation, function or energy source.
- Software that alters the settings or function of an infusion pump
- Software that regulates the inflation or deflation of a blood pressure cuff
- Software that can calibrate hearing aids and evaluates the sound intensity characteristics as well as electroacoustic frequencies of hearing aids.
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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