Intuit Inc. (Mountain View, CA)

One method of ensuring trust in a community is to select a data provider as well as a database entry entity from the community. The community is comprised of data providers who supply information, as well as entities that provide reviewers for data entry entities and data providers. The trust level of a data source level is determined according to the trust levels of provided and selected data entries.

Every year millions of users use software for various purposes, e.g., keeping the track of their the personal finances, managing projects as well as processing medical claims managing corporate accounting and financial data, filing necessary documents with thegovernment tax planning inventory management, company operation management (e.g., strategic planning sales forecasting, sales forecasting channel management, as well as other business-related activities), and the like. Most software applications are form-based, meaning that they provide the ability to do data entry, edit, and analyze using numerous forms related to an identical task. Software applications can present multiple forms and collect inputs through a user interface such as a GUI. Additionally, software that uses forms can create multiple output formsor documents using input data and certain algorithm embedded in the software application, commonly known as a generation engine or a calculation engine. The generation engine or the calculation engine can include functions to generate or calculate the result using logic or mathematical operations.

Software applications (e.g., financial software, medical software, inventory control software, and the like) must be able to be confident in the data source behind the multiple forms presented by the software. Whatever the data fields are input directly or are derived from other data, the reviewer must be able to determine the source of the initial data and evaluate the level of trust before they assess the validity (e.g. accuracy and reliability accuracy, precision, error-free, the data is in conformity to a standard model or any other acceptable measure of being valid). When providing data that is trusted it is crucial to ensure a certain level of quality. It is crucial to assess the quality of data and trust the data source. This is often multiple stages of.

Defining trust level configurations and specifications is a laborious and time-consuming procedure that comes with high costs for maintenance since trust levels and data sources can be changed rapidly. By sharing trust level offerings, a community can offer assistance in defining trust level configurations and maintaining them.

The invention is typically described as a means of controlling trust levels in a community. The method involves choosing a data provider from many data providers and then retrieving a data quality level from the community system. The level of data entry is based on the level of trust in the information as well as the quality of data level of each entity.

The invention is typically related to a system for community management that manages trust level within the community. The community system comprises a repository configured to store a number of trust level configurations, corresponding to a variety of providers in the community, a logic module operatively coupled to the repository and configured to receive and provide the various trust level configurations as well as a means to choose a service from a variety of providers based upon the atrust level configuration of the provider for meeting a predetermined requirement for an outcome trust level which is where the final trust level is generated by a program that uses the trust level setting of the chosen provider forindicating validity of the result.

One feature of the invention is a computer-readable medium that contains instructions for performing method steps to manage the level of trust in a community. The instructions include capabilities to store and receive a plurality trust level configurations, which correspond to a plurality providers in the community, and to select a particular provider according to the trustlevel configuration of the provider in order to attain a specified need for a trust level. Software applications generate the trust levels that result from the trustlevel configuration from the chosen provider, to verify the the validity of the result.

In general, in one way the invention is computer-readable media, embodying instructions executable by the computer to perform steps to manage trust levels within a community, the instructions comprising functionality toselect one of a plurality of data providers as well as an entity for data entry from a plurality of entities that are data entry from the community, in which the community includes a number of data providers providing a plurality of provided information, a variety of entities that provide data entry services, the multitude of data entry entities, and a number of reviewers, in order to collect the provided data as well as an amount of trust in the data supplied by the provider of the data, to determine the data entry quality level for the data entry entity from a community-based system, wherein the community system is comprised of a number of quality levels for data entry corresponding to the plurality of entities that are data entry and to calculate an appropriate source trust level determined by the level of trust in the data supplied and the data entry quality level of the entity responsible for data entry and the source trust level indicates validity of the data output produced by the entity processing the provided data.

Other aspects and advantages of the invention will become apparent from the following description as well as the appended claims.

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What is a software medical device?

The FDA refers to functions in software which may include ” Software as a Medical Device” (SaMD) and “Software in Medical Device (SiMD) ), which is software that is part of (embedded in) a medical device.

Section 201(h),?21 U.S.C. 321(h)(1), defines the term “medical device” as instrument, apparatus, device, machine, contrivance implant an in vitro reagent or any similar or similar item, which includes an accessory or component that’s . . . (b) is intended to treat or diagnose diseases or other ailments in animals or humans. (c) Is intended to modify the structure or functions of animals or human bodies. Thus, to be considered a medical device, and thus subject to FDA regulations, your software must meet one of two requirements:

  • It must be designed for use to diagnose or treat the patient
  • It must be intended to affect the structure or any functions of the body.

Therefore, if your program is designed specifically for health professionals to treat and diagnose patients or used in hospitals to manage patient data and patient information, the FDA would likely view such programs as medical devices subject to review by the regulatory authorities.

Is Your Software a Medical Device?

According to FDA’s current oversight strategy that considers the function of the software, rather than its device’s platform, FDA will apply its regulatory oversight only to medical devices that have functionality that could pose a danger to the safety of patients. Examples of Device Software and Mobile Medical Apps that FDA is focused on include

  • Software functions that aid patients with diagnosed mental disorders (e.g. depression, anxiety, post-traumatic stress disorder (PTSD) for instance.) by providing “Skill of the Day” or a behavioral strategy or audio message that users can access when suffering from anxiety.
  • Software functions that provide periodic educational updates, reminders, or motivational tips for smokers who are trying to quit, recovering from addiction, and pregnant women;
  • Software functions that use GPS location data to warn asthmatics of environmental conditions that may cause asthma symptoms, or to alert an addiction patient (substance abusers) when near a pre-identified high-risk or high-risk area.
  • Software that uses games and video to help people to do their take part in exercise at home.
  • Software functions that prompt users to select which drug and herb they wish to take simultaneously and give information on the likelihood of interactions being reported in the literature, as well as a summary of what type of interaction was reported;
  • Software functions that use the characteristics of the patient such as age, gender, and behavioral risk factors to provide patient-specific screening, counseling and preventive recommendations from well-known and established authorities;
  • Software functions that use a checklist of common symptoms and signs to provide an overview of medical conditions and advice on when to consult the health professional;
  • Software functions guide a user through a questionnaire of symptoms and signs to recommend the type of healthcare facility that is best suited for their needs.
  • Mobile applications are designed to enable users to make a pre-determined nurse call or emergency call by using broadband or cell phone technology;
  • Mobile applications that permit patients or their caregivers to create and send an alert or general emergency message to first responders;
  • Software that tracks medication and gives user-configured reminders to increase medication adherence.
  • Software functions allow users access to their health data. This includes historical trends as well as comparisons of vital signs (e.g. body temperature, heart rate or blood pressure).
  • Software functions that display trends in personal healthcare incidents (e.g. rate of hospitalization or alert notification rate)
  • Software functions allow the user to collect (electronically or manually entered) blood pressure data , and share this data through e-mail, track and trend it, or upload it into a personal or electronic health record;
  • Apps that provide mobile applications for tracking and reminders about oral health. They also provide devices to monitor users suffering from gum disease.
  • Apps that give mobile users access to information and tools for prediabetes patients;
  • Apps that allow users to display messages and images on their mobile devices, which are a great option for substance abusers who want to quit addictive behaviors.
  • Software functions that report information about safety and interactions with drugs (side effects and drug interactions active ingredient active ingredient) in a report based upon the demographics (age and gender) and current diagnosis (current medication), and clinical information (current treatments).
  • Software functions that permit surgeons to decide on the optimal intraocular lens strength for the patient and the direction of the implantation. This information is based on the surgeon’s inputs (e.g. the expected surgically induced astigmatism and patient’s axial length, prior to surgery cornea astigmatism, etc.).
  • Mobile apps, usually software, that transforms a mobile platform into medical devices that are regulated.
  • Software that can be connected to a mobile device by using a sensor or lead to measure and display the electrical signals generated by the heart (electrocardiograph, ECG).
  • Software that connects an eye sensor to the mobile platform, or other tools within the platform, in order to monitor or record the eye movements in order to identify balance issues
  • Software that collects information about potential donors, and then transmits the data to an institution for blood collection. This program determines whether a person is eligible to collect blood or other components.
  • Software that connects to an existing device to control its operation, function, or energy source.
  • Software that alters or disables the functions of an infusion pumps
  • Software that controls the deflation or inflation of a blood pressure cuff
  • Software that adjusts hearing aids, and also 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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