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What is a Software Medical Device for Recording medical information of the patient in self-contained portable memory device
Is Your Software a Medical Device for Recording medical information of the patient in self-contained portable memory device
The invention is a mobile, secure device that can be used to store and retrieve patient information.
Accurate, accessible and shareable health information is a well accepted prerequisite of good healthcare. Safety of patients and public safety, as well as continuity of patient care, the economics of healthcare research, clinical research and outcome analysis are negatively affected by the low quality of the health information available. The prior art has attempted to address these issues in the field of healthcare in not entirely satisfactory ways. The following patents provide examples of the prior art attempts at medicalrecord storage.
U.S. Pat. No. No. 5,832,488 to Eberhardt discloses an electronic system and method of writing medical records of individuals on a device for storage. These programs are able to store patient identification numbers and medical histories as well as pharmaceutical information. U.S. Pat. No. No.
U.S. Pat. No. 5,731,629 to Woodward divulges a personal data storage device that can be used to store information like medical records as well as a method for retrieving and storing such data from the storage device.
Of particular interest is U.S. Pat. Nos. 5,932,759 as well as 5,825,882 patent publications 2002/0128856 as well as 2002/0120470.
Recently, an attempt was made to embed a 32 k chip beneath a person’s skin with patient information that was uploaded to the chip. The format was characterized by two major drawbacks It required surgery and was expensive, and the information stored on the chip was quite small. Furthermore it was necessary to file the patents that were the parent (Ser. No. 10/605,127) of this patent application, other solutions have been suggested like those in the published Canadian U.S. Patent ApplicationSerial. No. No.
This invention provides a unique solution to the problem of medical records and is not described in prior art.
This invention is an portable security, safe, self-contained memory device, which when used with MyRECS.TM. copyrighted software is designed to save, update, and display medical records of a patient’s personal. MyRECS.TM. The MyRECS.TM. device is a small, handheld device that is connected to the USB port of a computer or reader adapter. Access to the medical data is provided by a unique password. The medical data stored on the device is unable to be altered or deleted. It can only be added.
The MyRECS.TM. device stores personal information, emergency contact details along with referral letters, reports, pictures, medicines immunizations, medical issues, allergies, surgeries, medical alerts, and other information that is necessary for the proper treatment of a patient. Each device is registered to a specific individual, and all information is stored in a secure encrypted database. An 800 number can be used in an emergency situation to gain access to the device and access the information.
This invention is designed to create a portable, small memory device that stores medical documents.
Another purpose of this invention is to create a new and improved portable, safe self-contained memory device which functions with software to store, update and display personal medical information.
Another purpose of this invention is to create an electronic storage device that can be used to store medical records. It is secured with a password and may be opened in the event of an emergency via a customer support center.
This invention is designed to offer an easy-to-use, portable enhanced memory device that can be used to store, update and display personal medical information. The password is not able to be removed, but only added. It could also be utilized to scan, enter into, or download.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA may refer to functions in software that comprise ” Software As a Medical Device” and “Software in a Medical Device(SiMD)” that is a software function that is integral to (embedded in) medical device.
Section 201(h) of the Federal Food Cosmetic, Drug, and Act, ?21 U.S.C. 321(h)(1), defines the term “medical device” as instrument, apparatus, implement or device, contrivance implant an in vitro reagent or any similar or similar device, that includes a component or accessory that is . . . (b) designed for use for the diagnosis of illnesses or other conditions or for the cure, mitigation, treatment, or prevention of disease, for animals or humans or (c) is designed to affect the structure or the functions of the body of man or any other animal.? To be classified as a medical device and therefore subject to FDA regulation the software must satisfy the minimum of the following conditions:
- It must be used in diagnosing and treating patients.
- It must be intended to modify the structure or purpose of the body.
So, if your application is designed specifically for healthcare professionals to diagnose and treat patients or in hospitals to manage patient records and patient information, the FDA would likely view such software as medical devices that are subject to review by the regulatory authorities.
Is Your Software a Medical Device?
FDA will regulate medical devices that have functions that may pose a risk for patient safety according to the current FDA oversight approach. FDA currently considers the functions of the software, rather than the platform. Examples of Device Software and Mobile Medical Apps FDA is focused on
- Software functions to help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder (PTSD) or depression, anxiety, obsessive compulsive disorder) maintain their behavioral coping skills by providing an “Skill of the day” behavior technique or audio-based messages the user may access during times of increased anxiety;
- Software functions that offer periodic reminders, motivational guidance as well as educational information for patients who are recovering from addiction or smokers trying to quit;
- Software functions that make use of GPS location information to alert asthmatics to environmental conditions that could trigger asthma symptoms, or to warn an addict (substance abusers) whenever they are near a designated high-risk or high-risk location.
- Software functions that use games and videos to entice patients to perform their exercise routines at home;
- Software functions which let users choose the herb or drug they wish to take simultaneously. They also give information about interactions , and provide the details of the type of interaction that was reported.
- Software functions that take into account specific characteristics of patients, such as gender age, gender, as well as risk factors, to provide specific counseling, screening and prevention recommendations from established and well-respected experts.
- Software functions that utilize an inventory of the most common symptoms and signs to give a list of possible medical conditions and advice on when to consult the health professional;
- Software functions that help users to answer a survey regarding their symptoms and then make a recommendation on the best type of medical facility to treat the patient.
- These mobile apps allow users to make nurse calls or emergency calls using technology like cell phones or broadband.
- Mobile apps that allow the patient or caregiver to design and transmit an alert or general emergency notification to first responders;
- Software functions that keep track of medications and provide user-configured reminders to improve medication adherence;
- Software functions allow patients access to their health records. This includes historical trending as well as comparisons of vital signs (e.g. body temperature, blood pressure or heart rate).
- Software functions that show trends in personal health events (e.g. hospitalization rates or alert notification rate)
- Software functions permit users to electronically or manually input blood pressure information, to share it via e-mail or track it, and then trend it, then upload it to an electronic health record.
- Apps that offer mobile apps for tracking and reminders about oral health. They also provide instruments to monitor patients suffering from gum disease.
- Mobile apps that provide prediabetes patients with guidance or tools to assist them develop better eating habits or increase physical exercise;
- Mobile apps that display at the right time pictures or other messages for a substance abuser who wants to stop addictive behavior;
- Software functions that report interactions between drugs and other medications as well as pertinent information about safety (side effects and drug interactions, active ingredient) in a report based on demographic data (age gender, age) as well as clinical data (current diagnosis), and current medications as well as
- Software functions allow surgeons to determine the optimal intraocular lens strength for the patient, as well as the axis of implantation. The information is based on surgeon’s inputs (e.g. anticipated astigmatism caused by surgery, the patient’s axial length, preoperative cornea astigmatism, etc.).
- Software, usually mobile apps, converts a mobile platform into a medical device that can be regulated.
- Software that connects with an mobile platform using a sensor or lead to display and measure electrical signals from the heart (electrocardiograph; ECG).
- Software that attaches an eye sensor to the mobile platform, or any other tool within the platform, in order to monitor, record, and analyze eye movements to identify balance issues
- Software that gathers data about potential donors, and then transmits the information to a blood collection facility. The software will determine the eligibility of a potential donor to collect blood or any other component.
- Software that connects with an existing device type to control its operation function or energy source.
- Software that alters the settings or functions of an infusion pump
- Software that regulates the inflation or deflation of a blood pressure cuff
- Software used to calibrate hearing devices and assess the electroacoustic frequencyand the characteristics of sound intensity, and 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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