What is a Software Medical Device for System for integrated medical emergency transport database
Is Your Software a Medical Device for System for integrated medical emergency transport database
1. Field of the Invention
This invention is a medical database system which incorporates. More specifically, this invention pertains to an integrated medical database that is used in the emergency medical transportation sector.
2. Description of the Technology Technology
Documentation procedures currently in use in the air medical transport industry are based on inefficient paper and pencil technology. A lot of important information is written on loose sheets. It’s difficult to arrange and document all the necessary information in an emergency situation. Data like demographic and medical information, dispatch data and patient charts are typically recorded in various forms. The data typically contain the same data, which is why it’s common for them to contain redundant data. This could cause charts to become unreliable and inaccurate. In a medical setting,incomplete information could lead to devastating clinical outcomes.
The same technology can be used to support industry quality improvement, billing procedures and to submit letters of transportation justification. This paperwork is usually completed at a later date, prolonging account receivable times in manyinstances to the point of compromising and jeopardizing service compensation. Extended turnover times can also lead to inventory tracking and stocking being inaccurate and inefficient.
The dispersion in the medical transport environment is also apparent in the myriad of entities throughout the country that practice different guidelines for treatment and documentation. As is the case in other sectors of the healthcare industry it is apparent that even the most basic task of communicating between different entities, as well as within a single providing entity, is severely hampered by the lack of a standard communication format. This is particularly evident when specific aspects of the system (such as computerized clinical laboratory result displays) have been updated with special computerized systems but the rest of the functions continue to be executed in a traditional way. Although the new system might be effectivefor one singular aspect that is dispatching, lab reporting or chart dictating, the remainder of the system does not enhance its efficiency due to the other archaic components.
While others have tried to resolve this conflict, there has not been a fully integrated medical system. For instance the Air Medical Software (Innovative Engineering of Lebanon, N.H.) provides computer software to dispatch emergency crews to the scene of an accident and for managing flight data. It doesn’t integrate flight data with the billing system, administration systems, or diagnostics for clinical use.
Medical transports using air suffer from the lack of understanding their efficacy by government as well as commercial and academic organisations. It is essential to gather solid data about how these systems save lives and justifytheir existence and expansion. Furthermore, medical crew evaluations and areas of improvement could be compared with the benchmarks that are in place after data regarding previous services become accessible.
Therefore, what is needed is a comprehensive system that incorporates modules to send out medical emergency teams monitoring their journey between and to the accident scene, managing an accurate diagnosis and treatment and accurately billing thepatient for the services rendered.
A computerized integrated data management system is a specific embodiment of the invention to track patient incidents. The system of data management comprises a first module that can send an emergency transport team to provide treatment to a patient in need of medical attention. A second module is capable of receiving information from this first module and billing the patient for the costs related to the incident.
Another version of the invention a computer-based integrated system for managing data and tracking a patient incident that comprises: a primary module that can interpret information relating to the medical condition of a person who is involved in an incident that requires emergency medical care by an emergency medical transport crew and in determining the diagnosis of the patient. There is a second module capable of receiving information from the initial module and billing the patient appropriately for the patient incident.
Another embodiment of the invention is a computer-based method of generating the patient’s encounter record. This procedure comprises the following steps: obtaining flight information related to an emergency transport team dispatch; gathering details about the patient from a clinical encounter that’s related to the patient’s situation and requires emergency medical treatment by the emergency transport provider; and finally, connecting the patient’s information together with the flight information to create a record of the encounter that records the patient’s medical encounter.
Another example of the invention is a procedure for diagnosing the condition of a patient. This method comprises the computer-implemented steps of gathering information from a physical exam at the scene of a patient’s incident requiringemergency medical care through an emergency medical transport team; determining a list of possible diagnoses based upon the physical examination; and recording the diagnosis results in a centralized database of patient emergency medical information.
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What is a software medical device?
Is Your Software a Medical Device?
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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