Disclosed are a method and apparatus for managing the data associated with managed health care and services, and more specifically an insurance managed program. This alleviates the burden on insurance companies by placing the required information on a credit-card-like medium which can be quickly scanned into an office, hospital or lab’s computer. The visible part of the device contains details and data about insurance. The card can be covered with a transparent protective laminate.

The disclosed method and device can be produced easily and used by many health care providers and service providers. This method provides guidelines for the conversion of information from encoded or other formats into system-compatible medical billing format. This cost-effective approach could be developed to reduce energy, time, resources, and avoid errors. Furthermore, such a system that is described and discussed in a part earlier, could also allow for more efficient care or services. This could be done by using a hand-held scanner such as a desk-top scanner or any other scanner.

The method and apparatus of this invention allow the recording, transmission, and analysis of insurance data, without restriction for all participating medical care providers with a significant decrease in the paperwork requirementsand as an added benefit is the ability to provide financial incentives for medical professionals who participate. The invention’s apparatus and method allow the collection and evaluation of insurance information by the patient. The medical professional then transmits details to the insurance provider. The invention meets the objectives of efficiently providing patient and insurance information.Therefore, reducing error filled forms and the resulting unnecessary costs and expenditures associated with remedying such errors. It is expensive and potentially life-threatening to misidentify or fill in incorrect or inaccurate information. Additionally, such information is “pre-coded” by the insurance provider. The insurance company is not able to contest the legitimacy of this information after a claim has been made for the services performed.

This invention will help you reduce the time spent in the office of the care provider.

Another object of the invention is to lessen the burden for the doctor and patient by completing complicated forms.

Another benefit of this invention is in avoiding essential information being forgotten.

Another benefit of the invention information being made accessible to the patient in case he or she is unable communicate.

Protecting confidential information is another reason for the invention.

This invention also guards against the unauthorised use of insurance cards.

Another object of the invention is to save time for data entry.

Another purpose of this invention lies in its cost efficiency for the provider.

Another goal of this invention is to remove errors in personal, medical and insurance data.

Another reason for the invention is to be easy to use.

This invention has an added benefit of speeding the process of billing and preventing the claims from being rejected.

This invention also aims to reduce the cost of reprocessing claims, and consequent communications with healthcare providers or patients.

Another object of this invention lies in the ease of use and benefits to health care patients and providers.

The above items can be encountered with a credit card that has readable and visually appealing information on photographic or recordable material i.e. the laser recording material that is which is recorded on the spot, then disposed of on a wallet-size credit card-like medium.Accordingly, readable information can be affixed to the card’s surface, could relate to any personal feature. Whereby other information pertaining to insurance or the company that insures it could be found similarly. One of the various devices can be used to capture details about the strip using melting, ablation or chemical alteration. This results in spots, codes or any other method of the dissemination and transfer of material. The stripes and spots of encoded materials will be represented by changes to reflectivity and the respective encoded material.

In situ laser recording allows for recording later of information and transactions related to previously recorded information. For example, claims for insurance or medical record entries may beprocessed sequentially in the recording of different transactions on a strip, or similar media and in succession, without erasing or selectively erasing predisposed data. Further protection against fraud may be provided by a photograph of the person who is claiming.

The device described herein provides an integrated solution that cuts down on time, indirect and direct expenses, and the need for duplicate or improper utilization of paperwork. This increases the capability of the system to provide top-quality services and health care by ensuring effective care management and interaction with providers.

The above and additional objects and features of the invention will become apparent from the following detailed description, which includes a description of an preferred embodiment by reference to the drawings.

Click here to view the patent on USPTO website.

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What is a software medical device?

The FDA can refer to the functions of software that comprise ” Software As a Medical Device” and “Software in Medical Device(SiMD)” that are programs that are integral (embedded in a) 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, instrument machines, devices, implant in vitro regulators, and other related articles, as well as an accessory or component. . . (b) is intended for diagnosis or treatment of illnesses or other conditions that affect animals or humans. (c) It is intended to alter the structure or functions of the human body or animal. Thus, to be considered a medical device, and thus subject to FDA regulation, your software must meet one of two criteria:

  • It must be intended to aid to diagnose or treat patients.
  • It must be intended to affect the structure or perform any purpose of the body.

Therefore, if your program is designed specifically for health professionals to diagnose and treat patients or used in hospitals for the management of information about patients 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?

FDA’s current oversight, which focuses on functional capabilities more than platforms, will ensure that FDA applies its regulatory oversight to only medical devices with capabilities that pose a risk to patient safety. Examples of Device Software and Mobile Medical Apps that FDA is focused on includes

  • Software functions that help those with mental disorders that are diagnosed (e.g. depression, anxiety, and post-traumatic stress disorder (PTSD) for instance.) by providing “Skill of the Day” an approach to behavior or audio-based messages which the user is able to access when suffering from anxiety.
  • Software functions that provide regular reminders, motivational advice, and educational information to patients who are recovering from addiction or smokers who are trying to quit.
  • Software functions that make use of GPS location data to warn asthmatics when they are near high-risk locations (substance abusers) and to inform them of potential environmental conditions that could cause symptoms.
  • Software functions that employ video and video games to motivate patients to do their exercise routines at home;
  • Software functions that require 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 observed;
  • Software functions that take into account the characteristics of the patient, like gender age, gender, as well as risk factors, in order to provide individual counseling, screening and preventive advice from well-established and well-respected experts.
  • Software functions that use an inventory of the most common symptoms and signs to provide an overview of health conditions and advise on when it is appropriate to speak with the health professional;
  • Software functions that lead the user through a checklist of signs and symptoms to recommend the health care facility most appropriate to their requirements;
  • The mobile apps enable users to make pre-specified nurse calls, or emergency calls, using broadband or cell phone technology.
  • Mobile apps that enable a patient or caregiver to create and send an alert or general emergency message to first responders;
  • Software functions that track the use of medication and offer user-controlled reminders to improve compliance with medication;
  • Software functions allow users access to their health records. This includes historical trends and comparisons of vital indicators (e.g. body temperature, heart rate or blood pressure).
  • Software functions that reveal patterns in personal health incidents (e.g. rate of hospitalization or alert notification rates)
  • Software functions allow users to gather (electronically or manually entered) blood pressure data , and share this data through e-mail, track and trend it, or add it into a personal or electronic health record.
  • Mobile apps that provide oral health reminders and tracking tools for users with gum disease.
  • Apps that provide mobile access and other tools for patients with prediabetes;
  • Apps that allow users to display messages and images on mobile devices which can be used by substance abusers who want to quit addictive behaviors.
  • Software functions that give 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), current diagnosis (current medication) as well as clinical information (current treatments).
  • Software functions that permit the surgeon to identify the most effective intraocular lens power for the patient as well as the orientation of the implant. The information is determined by the surgeon’s inputs (e.g. anticipated surgically induced astigmatism and patient’s axial length, preoperative corneal astigmatism etc.).
  • Mobile apps, typically software, converts a mobile platform into a medical device that is regulated.
  • Software that communicates with the mobile platform through an instrument or lead to monitor and display electrical signals from the heart (electrocardiograph; ECG).
  • Software that connects an eye sensor to the mobile platform, or any other tool within the platform, to view, record, and analyze the eye movements in order to diagnose balance disorders
  • Software that inquires about their history with donors and records and/or transmits those answers to the blood collection facility. This software determines the eligibility of a potential donor to donate blood or any other component.
  • Software that connects with an existing device type to control its operation function or energy source.
  • Software that alters or blocks the functions of an infusion pump.
  • Software that regulates the deflation or inflation of the blood pressure Cuff
  • Software used to calibrate hearing devices and evaluate the electroacoustic frequencyand the characteristics of sound intensity, and sound quality of 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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