United Services Automobile Association (USAA) (San Antonio, TX)

This document provides apparatus and methods for processing loss-paying payments. A device could comprise one or more data storages, a rule engine (an audit engine), and an engine for payment. In another instance, the method might include receiving a loss notice and determining a payee applying one or more rules with the data, determining whether an automatic payment could be made and transferring funds in the event that an automatic payment can be made. Another option is to get an alert, which may include one or more exposures. The method will then determine whether automatic payments can be made and removes the automatic payment for any potential exposure that cannot be made.

Customers demand more from the services and products they use more than they have ever. They demand that the businesses they deal regularly offer them higher and higher access to information and information. These companies are configuringand operating more and more sophisticated systems capable of delivering extremely integrated services to these customers.

For example, a customer who has an insurance contract through a firm that covers their car is expected to receive rapid resolutions when injured in an accident. Inexpensive processing times as well as numerous conversations between the customer and company can result in the loss of a customer. However, each automobile accident or loss is distinct and requires specific focus. The fact that auto accidents are a part of life has little impact on the client who makes keine allowances for the thousands of insurance claims that may be going through the same process as theirs. All they experience is a long process with very little satisfaction in the most difficult time of their lives.

An apparatus for providing automated payments may include at least one data store as well as a rules engine which executes one or more rules related to lost auditor that performs one or more audit functions, and a payment engine. Other embodiments could include a medical claims processor that can provide the ability to audit first-party medical losses. In a different embodiment, the rules engine is configured to derive an appropriate context for processing rules from the data.

A method for processing loss payments may include receiving a notice, determining the payee, implementing one to five rules, determining if an automated payment could be made, and then transferring funds, if feasible. In another example that involves deriving the payee, it could include determining coverage and liability for the loss and deriving the payee, if the payee is at least one person.

In a particular example, a method for processing payments for a loss includes receiving a loss notice, deriving each of the exposures, processing simultaneously, using one or more rules, determining whether an automatic payment is done, and removing an exposure from automatic payment while processing payments for the remaining exposures.

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What is a software medical device?

The FDA refers to functions in 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) an medical device.

Section 201(h),?21 U.S.C. 321(h),(1) defines the term “medical device” as apparatus, instrument machines, machines implants, devices, contrivances in vitro regulator and other related items in addition to an accessory or component. . . (b) intended for use to diagnose diseases or other conditions, or in the treatment or mitigation of disease, or prevention of disease, for animals or humans, or (c) intended to affect the structure or any function of the body of man or other animals.? So, in order to qualify as a medical device and therefore subject to FDA regulation, your software must meet two criteria:

  • It is essential to use it in diagnosing and treating patients.
  • It is not intended to alter the structure or the function of the body.

Thus, if your software is specifically designed for health professionals to treat and diagnose patients or in hospitals to handle 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 is focusing on the functionality of the software, not the platform, allows FDA to control only medical devices with functions that could pose dangers to the safety of patients. Examples of Device Software and Mobile Medical Apps that FDA is focused on includes

  • Software functions that help those suffering from mental illness (e.g., anxiety, depression, post-traumatic stress disorder (PTSD), etc.) through the use of “Skill of the Day” an approach to behavior or audio-based messages that the user can access when they are feeling anxious.
  • Software functions provide regular educational updates, reminders, or motivational guidance for smokers who are trying to quit, those recovering from addiction, or pregnancies women;
  • Software functions that make use of GPS location information to notify asthmatics when they’re in places of risk (substance abusers) or to warn them to environmental conditions that could trigger symptoms.
  • Software functions that use video and video games to motivate patients to do their physical therapy exercises at home;
  • Software functions that prompt users to select the herb or drug they would like to take concurrently and provide information about the likelihood of interactions being reported in the literature and an explanation of what kind of interaction was described;
  • Software functions that utilize factors that affect the health of a patient, such as age, gender and other risk factors for behavior to provide patient-specific screening, counseling and preventive advice from well-known and established authorities;
  • Software functions that make use of a checklist of common symptoms and signs to give a list of possible medical conditions and advice on when to see a health care provider;
  • Software functions assist users in completing a questionnaire of signs and symptoms to provide a recommendation for the type of health facility that is appropriate to their needs;
  • The mobile apps enable users to make nurse calls as well as emergency calls with the internet or cell phone technology.
  • Mobile apps that allow patients or their caregivers to design and send an alert or general emergency notification to first responders;
  • Software functions that track the use of medications and provide user-configured reminders for improved medication adherence;
  • Software functions that give patients with a way to access their own health information for example, access to the information gathered during a previous clinical visit or historical trends and comparison of vital indicators (e.g. body temperature and blood pressure, heart rate or respiration rate);
  • Software features that combine and show trends in personal health events (e.g., alert notification rates or hospitalization rates);
  • Software features let users electronically or manually enter blood pressure information, to send it out via email, track it and trend it, and then upload it to an electronic health record.
  • Mobile applications that give oral health reminders or tracking tools for users with gum disease.
  • Apps that offer mobile guidance and aids for prediabetes patients;
  • Apps that let users display images and other messages on smartphones, which are a great option for addicts looking to end their addiction.
  • Software functions that give safety and drug interaction information (side reactions and interactions with drugs active ingredient active ingredient) in an analysis based on information about demographics (age and gender) and current diagnosis (current medication) and clinical data (current treatments).
  • Software functions give the surgeon an inventory of intraocular lens strengths and the recommended an axis for implantation based upon the information provided by the surgeon (e.g., anticipated surgically induced astigmatism, the length of the patient’s axial axis and corneal astigmatism prior to surgery and so on.)
  • Mobile apps, usually software, that transforms mobile platforms into a regulated medical device.
  • Software that connects with the mobile platform through the use of a lead or sensor to display and measure electrical signals from the heart (electrocardiograph; ECG).
  • Software that connects a sensor or other tools to the mobile platform in order to view the eye’s movements to diagnose balance disorders
  • Software that collects data about potential donors, and then transmits the information to a blood collection facility. This program determines whether a person is eligible to donate blood or any other component.
  • Software that is connected to the device’s type in order to control its operation function, or energy source.
  • Software that alters or blocks the functions of an infusion pump.
  • Software that regulates the inflation and deflation of the blood pressure cuff
  • Software is used to calibrate hearing devices and assess the electroacoustic frequencies, sound intensity characteristics, and sound quality of hearing aids master hearing aids, group hearing aids 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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