What is a Software Medical Device for System to stop fraud on medical claims and other related methods
Is Your Software a Medical Device for System to stop fraud on medical claims and other related methods
There’s been a long-running issue with reimbursements for medical expenses made by insurance firms. Medical service providers or medical product provider will typically provide a service or product to a patient and then invoice the insurance company for a percentage of the cost. In certain cases it is the insurance company that is responsible for the full price of the product or service however in most instances the patient is accountable for a certain percentage of the cost for theseservices and products.
Insurance companies frequently require doctors and other medical supply companies to take lower payment rates as they seek to boost their profits. They often refer to as “negotiated” rates. They could be lower than what a doctor or medical supply company would charge for their services or products. As time goes on, the negotiated rates tend to have a negative effect on the profitability. A decrease in profitability could lead to certain medical professionals and medical supply businesses being exiled from the market. However, fraud could also be the result of reduced profitability. Examples of fraudulent conduct may include asking for reimbursements from insurance companies in exchange for medical services not provided to patients or products that are not offered to patients. In the past, frauds such as these were considered as non-victimless crime. Insurance companies are the only person to suffer. Accordingly, not much attention was paid to this issue until it been discovered that the fraud could be a source of rising healthcare costs.
Current systems that are utilized to monitor medical services that are offered to patients are not up-to-date and can be costly. After a medical service is completed by insurance companies, they may provide a patient with a written notice. The notice indicates the type of medical service that has been offered and also the portion of the treatment that was paid for by the insurance company. This system prevents fraud by notifying the patient about the kind or service that the medical professional is asking reimbursement. The patient should call their insurance provider to inquire about the issue if the service was not provided.
Several systems exist for conducting reviews of healthcare. For instance, U.S. Pat. No. 5,359,505 to Little et al. This system is a healthcare payment review and review system. The system evaluates and makes a decision on requests for healthcare payments made in exchange for services rendered by a health care provider. The system evaluates the request for payment according to the criteria specified by the user for review. This criterion could be based on the contractual agreements between payers patients and providers, current accepted local medical practices as well as the payment requests. The expert system collects prior payments to conduct the review and creates an overall list of payable requests for payment based on current medical procedures. The system analyzes the present payment request in relation to the pertinent prior payment requests as well as the master payable list by applying user-defined interpretive rules to this data. Payment decisions are developed and communicated based on the analysis.
Many times, medical services are only available to a patient when the patient is in within the same area that the physician is. There exist systems that track the locations of patients. For example, U.S. Published Patent ApplicationNo. Breazeale Jr. has filed a patent application No. 2009/0204434. This patent application outlines a method for tracking healthcare patients that automatically creates location-time data from the mobile device connected to a healthcare provider, and then correlates the data on location with the location of the patient. The system is designed to make sure that patients are paid for the actual procedure. In order to bill for a trigger event, the billing utilizes the location information of the patient.
U.S. Published Patent Application No. 2007/0299776 by Frustaci et al. Frustaci and colleagues. present the method of preventing medical fraud. The system utilizes real-time transmitted identification systems to confirm patient identification, location and time and medical service provider identification. The system confirms the provision of services to an authorized service customer through assigning a unique identification number to each authorized service provider , and by assigning a unique identifying number to every licensed service user.The system determines the likelihood that an insurance claim submitted by a service provider is valid by defining the unique identifying feature of each authorized patient and also for all authorized doctors. The system is directed todetermining probabilities of whether the medical claim may be fraudulent. The Frustaci et al. The Frustaci et.al. The system takes the fingerprints of both the patient and the provider and sends them to a service confirmation centre in real-time.
U.S. Pat. No. There is no. The system utilizes biometric data that is unique to an individual and location information to create permanent records that prove that a person was in the area in a particular location.
The present invention offers an advantage in the prevention of fraudulent medical claims through an efficient system for confirming that a patient is present while a claim is filed. The present invention alsoadvantageously accelerates the process associated with the medical professional who receives the medical payment. This invention also gives a variety of methods to locate a patient so as to provide redundancies and backups toensure that an appropriate medical claim isn’t rejected.
The above and many other features as well as features and benefits as per the present invention are provided through a medical fraud prevention system that consists of an initial controller that is located in a medical facility and another controller located in a patient information collection center. The second controller can be configured to be in communication with the primary controller.
The fraud prevention for medical claims system could contain a patient-locating device adapted to be within a predetermined vicinity of a patient and adapted to be in communication with the second controller to provide location data relating tothe location of the device. The first controller can transmit a signal to the second controller in response to the incident that is predetermined. The second controller could send an indication to the first controller in response to the first signal sent by the first controller of whether the device that locates patients is located within the predetermined proximity of the medical facility based upon the location information relating to the position of the patient locating device.
A patient may be assigned a specific unit based on patient information. Receiving information from the patient unit could be a predetermined moment. A reader for the patient information unit could be the controller first, that can read specific patient data.
A medical device in communication with the first controller can be utilized by a physician at the medical facility. When making use of the medical software system medical professionals may be asked to enter data regarding the patient. The predetermined event in these cases may be the entry of information about the patient using the health software. In addition, billing systems can be utilized by the medical establishment to charge the patient for services they provide. In such cases, the predetermined event could include the use of the billing system in relation to the patient. The system of the invention has a variety of methods for prompting the location of the patient.
The patient locating device could be an GPS enabled electronic device. An emitting device that could be triangulated to pinpoint the patient’s location data may also be used. The medical facility can be a doctor’s clinic or a hospital, pharmacy or therapy center, a medical laboratory, a medical clinic, rehabilitation center or dialysis unit or an outpatient center or assisted living facility as well as an emergency room or a nursing home.
Processing of claims for health insurance can involve the use of the patient information collection center. The signal transmitted from the first controller to the second controller may include information relating to a claim for reimbursementrelating to medical services being provided to the patient at the medical facility. The second controller may transmit a signal to first controller indicating of whether or not the claim is a valid claim based on the indication ofwhether the patient locating device is within the specified vicinity of the medical facility. The invention cuts down on the time required to approve a medical claim.
A backup locating system could also be integrated into the system. It is activated to take an action in response to an event that is predetermined for backup. The event that triggers the backup that triggers the backup location system may be an indication received from the second controller that the patient locating device is not in the predetermined vicinity of the hospital. A mobile phone may be the patient locating device. The predetermined procedure could be to contact the mobile phone and speak with the patient in order to find out the patient’s location. Another predetermined step is to call the medical facility and request the patient for verification of their location with a predetermined patient identification. The alternative could include calling the medical facility, speaking with the patient and requiring the patient to confirm their location using a predetermined patient identification number.
The invention presented herein provides a method for stopping fraudulent medical claims. A first signal can be transmitted from the first controller in the medical facility to the second controller at the centre for patient information in response to an event. The method may also include transmitting an indication from the second controller to the first controller in response to the initial signal received by the first controller of whether the patient-locating device is within the predetermined area of the medical facility, based on the location information relating to the position of the device.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA may refer to software functions that include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)”, which are applications that are integrated (embedded within) a medical device.
Section 201(h),?21 U.S.C. 321(h)(1), defines an medical device as instrument, apparatus, instrument an instrument, device implant an in vitro reagent or other similar or related article, including an accessory or component, which is . . . (b) designed for use in the diagnosis of illnesses or other conditions or in the cure, mitigation, treatment, or prevention of diseases for animals or humans or (c) is designed to affect the structure or the function of the body of man or other animals.? To be classified as a medical device and consequently subject to FDA regulations, the software must meet the minimum of these criteria:
- It must be used in diagnosing and treating patients.
- It is not intended to affect the structure or perform any purpose of the body.
Thus, if your software is specifically designed for health professionals to treat and diagnose patients or in hospitals for the management of patient information and patient information, the FDA would likely view such software as medical devices subject to regulatory scrutiny.
Is Your Software a Medical Device?
In accordance with FDA’s current approach to oversight, which considers the functionality of the software higher than the platform, FDA will apply its supervision only to devices for medical use that possess functions that be a risk to patient safety. Some examples of Device Software and Mobile Medical Apps that FDA is looking at include
- Software functions that help those suffering from mental illness (e.g., anxiety, depression, post-traumatic stress disorder (PTSD), etc.) by providing “Skill of the Day” an approach to behavior, or audio messages, that the user can access when experiencing anxiety.
- Software functions that provide periodic educational updates, reminders, or motivational guidance to smokers trying to quit, addicts who are recovering from addiction and pregnant women;
- Software functions that use GPS location information to notify asthmatics of environmental conditions that could trigger asthma symptoms or alert an addiction patient (substance abusers) whenever they are near a designated high-risk area;
- Software that uses games and videos to motivate patients to take part in exercise at home.
- Software functions that prompt users to select which herb and drug they wish to take concurrently and provide information about the possibility of interactions in the literature and an overview of the type of interaction was reported;
- Software functions that consider patient characteristics, such as gender, age, and risk factors, to provide patient-specific counseling, screening, and preventive advice from established and respected authorities.
- Software functions that make use of the list of symptoms and signs to give advice about when to see the doctor and what next.
- Software functions assist users in completing the questionnaire of symptoms and signs, to offer a recommendation for the type of health care facility most appropriate to their needs;
- These mobile applications allow users to make pre-defined nurse calls or emergency calls using the internet or cell phone technology.
- Apps that allow patients or caregivers to send emergency notifications to first responders using mobile phones
- Software functions that track the use of medication and offer user-defined reminders for better drug adherence
- Software functions allow users access to their health information. This can include historical trending as well as comparisons of vital indicators (e.g. body temperature, heart rate or blood pressure).
- Software functions that show trends in personal health events (e.g. hospitalization rates or alert notification rate)
- Software features permit users to either manually or electronically enter blood pressure data, and to send it out via email or track it, and then trend it, and upload it into an electronic health record.
- Apps that offer mobile apps to track and remind users about oral health or 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 can be used by addicts looking to quit addictive behaviors.
- Software functions that provide safety and drug interaction information (side effects and interactions between drugs active ingredient active ingredient) in an analysis based on demographic data (age and gender) as well as current diagnoses (current medications) as well as clinical information (current treatments).
- Software functions provide the surgeon with an inventory of intraocular lens power and suggested the axis of implantation, based on information inputted by the surgeon (e.g. an predicted surgically induced astigmatism patient’s axial length , cornea astigmatism prior to surgery, etc.)
- Software, usually mobile apps that converts a mobile device into a regulated medical device.
- Software that connects with an mobile platform using the use of a lead or sensor to monitor and display electrical signals coming from the heart (electrocardiograph; ECG).
- Software that attaches an eye sensor to the mobile platform or any other tool within the platform, to view the eye movements, record and analyze the eye movements to diagnose balance disorders
- Software that collects information about potential donors and sends it to an institution for blood collection. The software helps determine if a potential donor is eligible before collecting blood or any other component.
- Software that connects with an existing device to control its operation, function, or energy source.
- Software that alters the functions or settings of an infusion pump.
- Software that regulates inflation or deflation of a blood pressure cuff
- Software is used to calibrate hearing devices and evaluate the electroacoustic frequency, the characteristics of sound intensity, and emanating from hearing aids master hearing aids, group hearing aids, or group auditory trainers.
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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