What is a Software Medical Device for Healthcare system that is based on the needs of the client and process
The present invention pertains to healthcare and, more specifically, to a sophisticated healthcare system and process that is driven by the client in a computerized system centered around an interactive, real-timeclient record to provide better quality healthcare with increased client interaction and accessibility, but at reduced costs.
In the next few years, many local health markets are set to experience even more change as the provider-dominated system loses the advantage of managed care penetration. Local economies are flourishing through construction, tourism and retailsales. Population growth is on the rise and is expected to grow. Sometimes in the past these two items have been in conflict. The provision of quality healthcare with increased client access and controlled costs is a problem to which considerableattention need be given. It is necessary to educate and create wise medical consumers so that healthcare consumers and their doctors are able to collaborate in managing health problems and costs.
In the past, healthcare systems and processes utilized a flow of clients or flow of patients. Numerous electronic inputs were used to facilitate the process. U.S. Pat. No. 5,319,543 describes an electronic medical record system using a work flow procedure rather than central database methods. This system responds by routing specified instances to work queues that are specific to the. This patent doesn’t offer a user-driven immediate access to information about patients and information is processed in queues. U.S. Pat. No. No. 5,594,638 is a description of a system that offers electronic medical diagnosis, treatment guidance, and other information. It is commonly known as an expert system. The attelephone system provides medical guidance. Patients have access to their information almost immediately. The system gives medical advice on around 100 medical conditions common to everyone and is accessible to anyone, even non-medical. U.S. Pat. No.5,823,948 discloses a system for tracking of patients and medical records. The system provides real-time access to the patient’s history. Additionally, the system can automatically receive and store information from outside sources, such as X-ray,transcriptions, labs, registration, central supply and the pharmacy. This system can be utilized by nurses, doctors as well as other medical professionals. It can also give instructions for discharge or exit. U.S. Pat. No. 5,845,253 describes a method of processing and recording patient data using a handheld device so that historical information can be preserved. To represent the patient’s condition the system employs clinical codes. Questions are directed at the user to gather information regarding the patient. In general, this approach aims to improve the information collected from the patient and to keep more accurate the medical record. The use of a handheld computer makes the process mobile while the collected data is sent to the standard desk top at varying intervals. U.S. Pat. No. 5,867821. 5,867821 describes a technique for distributing and managing entertainment, medical services and educational materials to patients in an electronic format. The system is principally an information retrieval system that can retrieve information previously recorded. This system does not address the method in which the data should be gathered. U.S. Pat. No.5,869,822 describes a fingerprint identification system that is used with an encrypted identification card. When the card is made it converts the fingerprint to numbers and stored. Following use of the card is dependent on the fingerprint be betaken again transformed into numbers, then it is compared with the fingerprint that was present when the card was created. The card can be used when the numbers are in line.
The purpose of this invention is to provide an integrated health system and procedure that is primarily client-driven wherein the client’s healthcare is a collaborative decision. the health of the patient.
Another goal of the invention is to provide an integrated healthcare system and process that is centered around a live client record which is originated by the user on a system computer . It is then accessed by various clinical and business stations for patient/patient review and input. This will provide quality healthcare to patients at a lower cost.
Another purpose of the current invention is to offer the healthcare system that is primarily driven by the client and process which focuses on the mind, body, and spiritual aspects of treatment where the patient is fully involved. Holistic, complementaryhealthcare, covering a broad spectrum of integrated therapies, is enjoying a renaissance.
Another objective of the present invention is to create a healthcare system and process with a variety of clinical stations connected in an integrated computer network. A real-time client record is accessible by both the medical and client personnel as the client progresses through the system and process and a final report for take-home is generated that includes all pertinent details regarding the care of the patient.
The above goals are achieved in accordance with the present invention by providing an advanced integrated healthcare system as well as method for processing a variety of clients in a client-driven and time-efficient manner using a facility whileproviding high-quality healthcare at a lower cost that includes the use of a computer network with at minimum one central system computer that is readable by a computer medium. The system computer program is installed on the computer system which includes instructions embodied incomputer readable code to create a real-time client record which is saved in a database of the system as the client’s information is processed by the system. This is the “e”, which connects the internet, data, and fax to the client.
Clients who visit the facility are received at various client stations equipped with computers that are connected to the network of computers. A client station has an input device that can connect to the terminal for input of details about the client to create a client record. Instructions to ask clients to answer questions regarding their health and creating a diagnosis of the health of the client from the responses part of the system program. The client station has an input identification device for generating a computer readable IDcode that identifies the user and the client’s record. Other stations within the system and the process also have networked ID input devices so that the client record is accessible from any of the stations. The ID device has a fingerprint sensor that can detect the client’s fingerprint and then provide the ID number. The nurse station has a computer terminal that connects to the computer network. This terminal provides access to the client’s record it also collects vital indicators as well as other information from lab clients. It also has a nurse station input which permits the nurse station to add the data in the client’s file as laboratory data. The nurse station has several automated blood analysis equipment which include hematology pulse, blood pressure and temperature. “vital signs” machine, as well as a blood chemical analysis machine that is connected to the computer system for direct input of lab data. A practitionerstation is where medical professionals from a variety of fields are stationed to serve clients. One or more of the practitioner stations should include an electronic terminal for computers that is able to access the client record, and a monitor to show the client’s record. The practitioners and the client can access the computer terminal within the examination room or station during the examination for collaborative decision-making. An input device at the station can be used to enter exam data into the client record. Alternate therapy stations can be offered where clients may review alternate therapy options and talk to practitioners certified in alternative and complementary treatments. An attached computer terminal could be used to create choices data that indicate recommended treatments. This includes alternative naturopathic and acupuncture chiropractor, massage, nutritional therapies and many more. A report that includes recommendations is generated based on patient records. The client is able to take the report home following the session.
The facilitator will welcome the first-time client to the center and leads them to their assigned station. The facilitator will welcome the first person to the center. They direct the client to the appropriate station and assist them with their biographic and demographic information. When instructed to enter it on subsequent visits, the customer inserts their finger into the sensor to instantly identify, record access andrecall. After inputting the fingerprint identification the client is then prompted to input, via a touch screen, the reasons of the visit, the symptoms, complaints, and upgraded status of condition and the history of the condition. The patient is taken to a triage station where fingerprint identification will bring to light his notes regarding the visit, which includes any complaints, screenings and promotional materials. The information regarding the selection of services that was made earlier is accessible in real-time in the computer.At the nurse station, vital signs as well as samples of laboratory tests are taken and processed. The results of the nurse station are downloaded to the client’s record in the system database. The client is then transferred to the doctor’s station for a private consultation and examination with either an allopathic physician or, if desired an alternative healthcare professional are performed. The real-time client record is then brought to the computer screen through fingerprint recognition at the station of the practitioner. The client’s records, their current concerns, complaints or symptoms and the triage results are evaluated by both the doctor and the client. Then, they discuss. Collaborative decisions, specific to the complaint of the client, are made while viewing medical data and the thereal-time record online. Based on the guidelines suggested and guidelines for practice, the final decision-making is made. Material from the medical database program pertinent to the client’s clinical educationalinformation needs is printed for a client take home folder. Prescriptions are electronically sent to the preferred pharmacy or printed from the client’s file of the client. The practitioner and the client jointly make decisions about clinical and/or alternative therapy options. Alternative and therapeutic options are reviewed, documented, and then recommended. The treatment options may be then administered at the clinic or the client can be instructed at home. Herbal, vitamin, and nutraceutical supplements, based on recommendations and mutual choices, are recorded in the client record database after having purchased at the center’s herbal emporium station. The customer leaves the center with a file of information about the current time of his visit. The client has access to his record by using an electronic fingerprint sensor during future visits and updates the information immediately.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)” (SiMD) are functions of software that are integral to (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 the term “medical device” as apparatus, device, machine, contrivances, implant in vitro regulators, and other similar items in addition to an accessory or component. . . (b) designed for use in the diagnosis of illnesses or other conditions or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or (c) designed to alter the structure or any function of the body of man or any other animal.? Thus, to be considered a medical device and therefore subject to FDA regulations, your software must meet one of two criteria:
- It is essential to use it in the diagnosis and treatment of patients.
- It is not intended to modify the structure or perform any function of the body
Therefore, if your program is specifically designed for healthcare professionals to treat and diagnose patients or used in hospitals to manage patient information and patient information, the FDA is likely to view the programs as medical devices subject to regulatory review.
Is Your Software a Medical Device?
According to FDA’s current approach to oversight, which considers the functionality of the software, rather than its device’s platform, FDA will apply its regulation only to medical devices with functions that pose a danger to the safety of patients. Examples of Device Software and Mobile Medical Apps that FDA is looking at include
- Software functions to help those suffering from psychiatric disorders diagnosed (e.g. post-traumatic stress disorder (PTSD) or depression, anxiety, or obsessive compulsive disorder) keep their behavioral coping skills by providing a “Skill of the day” behavioral technique or audio-based messages the user may access during times of increased anxiety;
- Software functions provide regular educational information, reminders, or motivational guidance to smokers who are trying to quit, those who are recovering from addiction or pregnancies women;
- Software functions that make use of GPS location information to alert asthmatics to conditions in the environment that could trigger asthma symptoms, or to notify an addiction patient (substance users) in proximity to a specified high-risk or high-risk location.
- Software functions that employ video and video games to encourage patients to do their exercises in their own homes;
- Software functions that prompt the user to input the herb or drug they would like 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 described;
- Software functions that make use of the characteristics of the patient like age, gender and other risk factors for behavior to provide patient-specific screening, counseling and preventive recommendations from well-known and established authorities;
- Software functions that utilize a checklist of common symptoms and signs to provide an overview of health conditions and advise on when to consult an expert in health care;
- Software functions help patients to complete a questionnaire regarding symptoms and make a recommendation on the most appropriate healthcare facility for the patient.
- Mobile apps are designed to allow a user to initiate a pre-specified nurse call or emergency call using broadband or mobile phone technology;
- Mobile apps that allow the patient or caregiver to design and send an alert or general emergency notification to emergency responders.
- Software functions that track the use of medication and offer user-configured reminders to ensure better medication adherence;
- Software functions allow users access to their health data. This includes historical trends and comparisons of vital sign (e.g. body temperature, heart rate or blood pressure).
- Software functions that reveal trends in personal healthcare events (e.g. hospitalization rates or alert notification rates)
- Software tools allow users to either manually or electronically enter blood pressure data, and to share it with e-mail, track it and trend it, and then upload it into your personal or electronic health record.
- Mobile apps that allow to track and remind users about oral health or tools to track users who suffer from gum disease.
- Apps that offer mobile guidance and tools for prediabetes patients;
- Apps that allow users to display messages and images on mobile devices, which are a great option for addicts looking to end their addiction.
- Software functions that provide drug-drug interactions and relevant safety information (side effects, drug interactions, active ingredient) as a report based on demographic information (age, gender) and medical data (current diagnosis) and current medications as well as
- Software functions allow the surgeon to have the list of suggested intraocular lens strengths and the recommended axis of implantation based on information inputted by the surgeon (e.g. an anticipated surgically induced astigmatism, length of the patient’s axial and preoperative corneal astigmatism and so on.)
- Software, typically mobile apps, that converts the mobile platform into an FDA-approved medical device.
- Software that is connected to a mobile platform by using a sensor or lead to measure and display the electrical signals generated by the heart (electrocardiograph, ECG).
- Software that attaches a sensor or other tool to the mobile platform so that it can monitor the eye’s movements to identify balance issues
- Software that collects information about potential donors and transmits the information to an institution for blood collection. This program is used to determine if a person is eligible before collecting blood or any other component.
- Software that is connected to an existing device in order to control its operation, function, or energy source.
- Software that modifies or disables the functions of an infusion pump
- Software that regulates inflation or deflation a blood pressure cuff
- Software used to calibrate hearing devices and evaluate the electroacoustic frequency, audio intensity characteristics, as well as emanating from hearing aids master hearing aids hearing aids for groups 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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