1. Field of the Invention
The present invention is in the medical industry and, more specifically, to a multi-functional medical software software program that can be utilized to aid in concurrent review hospital discharge or ongoing stay recommendations; to determine effectiveallocation of hospital staff as well as other resources; and to obtain data to support quality improvement initiatives.
2. Description of the Prior Art
The costs of healthcare are increasing all over the globe and healthcare professionals have to take difficult decisions about how they can offer the best services for their patients at a reasonable cost. Although most clinicians would prefer to buy the latest medical technology available but they cannot afford to purchase it while caring for their patients in an affordable manner.
To provide the best health care possible It is essential to determine when and when the patient will be let go. Numerous lawsuits were filed in this aspect of health care, which drives up the cost of healthcare. The subjective judgment of a physician to decide whether a patient should be kept in a hospital is the basis for determining if they should. An incorrect decision could have devastating economic implications for healthcare, as well as directly impacting the well-being and life of the patient. A number of hospitalization decisions have resulted in bitter lawsuits and disputes between the hospitals, the insurance companies, and patients.
To prevent these disputes, several methods have been used to offer a logical basis for hospital stay/discharge decision making. These systems can be difficult to use and often produce unclear conclusions.
Effectively allocating hospital personnel and other medical resources is a different way to improve efficiency in health care. There are often multiple areas within a hospital or medical center which are either not adequately or overstaffed. These areas may not be able of diagnosing and manage patients efficiently. In the event that all departments are adequately staffed of the hospital, resources may be utilized more efficiently to better serve the patients and lower costs for health care.
It is desirable to provide an apparatus and method that overcomes the problems associated with the prior technology. The system and method will allow for more efficient health care. The system and method will decide how and when a patient should be discharged. The system and method will also determine the most efficient distribution of hospital staff and other resources. The method and system could be used to gather data that will help with improving quality of care projects.
One version of the invention describes a computer system which includes processors to execute program instructions and an internal memory to store program instructions. The programminginstructions comprises: enter intake data on a patient; entering at least one of symptoms the patient is experiencing and services performed on the patient, wherein all symptom and services listed in the program instructions are assigned a numeric numberbased on severity of the symptom and service; calculating total value of all numeric values of symptoms patient is experiencing and services performed on the patient; and making a recommendation to one of continue hospital stay or discharge of thepatient.
A computer system is described according to another version of the invention. It includes processors that execute instructions for programming and a memory for storing the program instructions. The programminginstructions comprises: enter intake data on a patient; entering symptoms the patient is experiencing and services performed on the patient, wherein all symptom and services listed in the program instructions are assigned a numeric number based onseverity of the symptom and service; calculating total value of all numeric values of symptoms patient is experiencing and services performed on the patient; making a recommendation to one of continue hospital stay or discharge of the patient; listing aplurality of different conditions/illnesses; displaying guidelines to show how to treat a selected condition/illness; entering marks for indicating that a particular measure has been taken to treat the selected condition/illness; monitoring resourcesconsumed by all patients for one of a particular hospital, floor, and ward; and reviewing data to determine if one of the hospital, floor, ward has sufficient supplies and staffing.
The advantages, functions and advantages may be achieved independently in various embodiments of the present inventions or be combined into yet other embodiments.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)” These are programs that are integral (embedded inside) medical device.
Section 201(h),?21 U.S.C. 321(h),(1) defines the term “medical device” as apparatus, instrument or devices, a machine, an implant in vitro regulators, or any other similar or related items and a component or accessory. . . (b) is designed to diagnose disease or other conditions or treat, mitigate or prevent these. (c) can have the possibility of altering the structure or function of the body of animals. So, to be considered a medical device , and therefore subject to FDA regulation, your software must satisfy one of two criteria:
- It is essential to use it in diagnosing and treating patients.
- It should not be designed to change the structure or function of the body.
So, if your application is designed specifically for healthcare professionals to treat and diagnose patients or in hospitals for the management of patient information, the FDA is likely to view the programs as medical devices subject to review by the regulatory authorities.
Is Your Software a Medical Device?
As per FDA’s current oversight strategy that considers the function of the software, rather than the platform, FDA will apply its supervision only to medical devices that have functions that be a risk to patient safety. Examples of Device Software and Mobile Medical Apps that FDA is focused on includes
- Software functions that help patients with diagnosed psychiatric conditions (e.g. post-traumatic stress disorder (PTSD) or anxiety, depression, obsessive compulsive disorder) retain their strategies for coping by offering a “Skill of the Day” behavior technique or audio-based messages the user can use when they are experiencing an increase in anxiety;
- Software functions provide regular information on education, reminders, or motivational advice to smokers who are trying to quit, those recovering from addiction, and pregnant women;
- Software functions that utilize GPS location information to notify asthmatics when they are near high-risk locations (substance users) and to inform them of potential environmental conditions that could cause symptoms.
- Software functions that make use of games and videos to encourage patients to do their exercise routines at home;
- Software functions that prompt a user to enter which drug and herb they wish to take concurrently and provide information about whether interactions have been seen in the literature and an explanation of what kind of interaction was observed;
- Software functions that are able to take into consideration the characteristics of patients, like gender age, gender, and other risk factors, to provide specific counseling, screening and prevention recommendations from established and highly-respected experts.
- Software functions that use a list of common symptoms and signs to give information on when to visit a doctor and what you should do next.
- Software functions that help users to navigate through a questionnaire regarding symptoms and provide a recommendation of the most appropriate healthcare facility for the patient.
- Mobile apps are intended to enable users to initiate a nurse call or emergency call by using broadband or cell phone technology.
- Apps that let patients or caregivers to transmit emergency notifications to first responders through mobile phones
- Software that tracks medications and gives user-controlled reminders to improve medication adherence.
- Software functions that give users access to their health data. This can include historical trending as well as comparisons of vital signs (e.g. body temperature, heart rate or blood pressure).
- Software functions that reveal trends in personal healthcare incidents (e.g. rate of hospitalization or alert notification rates)
- Software tools let users either manually or electronically enter data on blood pressure, to share it with e-mail, track it and trend it, then upload it into your personal or electronic health record.
- Mobile applications that give oral health reminders or tracking tools for those suffering from gum disease.
- Mobile apps offer patients suffering from prediabetes with advice or tools that can help them develop better eating habits, or to increase physical activity;
- Apps that allow users to display messages and images on their smartphones, which are a great option for addicts looking to stop their addiction.
- Software functions that report safety and drug interaction information (side effects and drug interactions active ingredient active ingredient) in reports based on demographic data (age and gender), current diagnosis (current medications) and clinical data (current treatments).
- Software functions that provide the surgeon with a list of recommended intraocular lens powers and recommended the axis of implantation, based on information supplied by the surgeon (e.g. the predicted surgically-induced astigmatism, patient’s axial distance and preoperative corneal astigmatism, etc.)
- Mobile apps, typically software transforms mobile platforms into a medical device that can be regulated.
- Software that communicates with an mobile platform using an instrument or lead to measure and display electrical signals from the heart (electrocardiograph; ECG).
- Software that connects a sensor or other tools to the mobile platform to monitor, record and analyze eye movement to detect balance problems
- Software that gathers data about potential donors and sends the information to a blood collection facility. The software helps determine if a person is eligible to collect blood or other components.
- 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 pumps
- Software that regulates inflation or deflation a blood pressure cuff
- Software that is used to calibrate hearing devices and evaluate the electroacoustic frequency, audio intensity characteristics, as well as sound quality of 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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