Computers were typically large because of the sheer number of components required to provide computing power, like a mainframe computer. With the advent of personal computers computers which were once the dimensions of a room could be trimmed in size to fit into the same desktop. However, desktop computers which require a massive tower to house the processors, a monitor and keyboard are not conducive to be transported from one location to the next. Laptop computers are lighter and less bulky than desktop computers. They include the processor as well as the keyboard, monitor and mouse all in one package. However, laptop computers aren’t the smallest in size and also sacrifice quality as contrasted with desktop computers. Moreover, desktop, laptop and mainframe computers all suffer from being susceptible to data corruption from malware or viruses as well as to hacker attacks to steal data. Computers need to be protected from all of these threats, but they must also be portable and easy to use almost everywhere.
A portable computing device is required that can be utilized in a variety of applications, and also safeguards sensitive information. The present invention provides a computing system that satisfies these needs and provides additionaladvantages.
The present invention is an example of a computing system comprised of the portable computer. The portable computer includes all the necessary components for a conventional all-purpose, fully functional computer. It is smaller than a credit-card and is able to be carried in a wallet or pocket. The portable computer can only use readers in certain configurations. The details of these are explained below. The portable computer reader provides the user with the capability to interact with the computer portable as well as the software that runs on it. For example the portable computer reader may include a display and/or a keyboard. The portable computer reader functions as a non-functioning “shell” whennot connected to the computer in the portable. The computer reader portable can connect to the computer and the system will then be fully functional. The portable computer thusacts as the brain and the portable reader functions as a body that will do the work, but, without the brain, the body is unable to perform any functions.
Once the user is done when they are done, they can remove the computer and take it away with the rest of their belongings. The portable computer reader acts as a shell and does not leave any trace of user’s data behind. Thus, various embodiments don’t make any data, including sensitive information, available to subsequent users of the portable computer reader. Also, there is no possibility that the portable reader will be infected by a virus. The portable reader can’t retain data from previous users. As a result, the apps for portable computers are almost limitless where security and privacy is an issue, as well as where theremay be concern of damage caused by viruses or worms. For instance, the applications can be found in however, they are not restricted to hotels, internet cafes, or other places that are public like libraries, universities, for example.
Furthermore, various versions provide the versatility of a “Pocket PC” that has the benefits and features of a conventional computer. For example the computer portable is easily moveable, and the portable computer reader provides use of afull computer with a large screen, keyboard, etc.
Finally, in certain embodiments the portable computer might include at least one flash memory device or flash drives. A flash drive is a storage device that utilizes flash memory instead of traditional spinning platters for storing information. Advantagesof using flash memory or flash drives when connected to the portable computer is that there is minimal delay in starting up, which happens when you boot conventional computers. Flash memory is also non-volatile. This means that it does not require power to store the data within the device. As a result, the portable computer needs only a small amount of power to operate, which can be readily powered by batteries or similar low power sources like solar cells. Flash memory can be tailoredto provide the amount of storage that is required, based on the particular application.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA refers to software functions that may comprise ” Software as a Medical Device” (SaMD), and “Software in Medical Device (SiMD) ), which is software that is integrated into (embedded inside) a medical device.
Section 201(h),?21 U.S.C. 321(h),(1) defines medical devices as apparatus, device machines, devices, implant in vitro regulators, and other related articles in addition to a component or accessory. . . (b) is intended to be used in the diagnosis of illnesses or other conditions or in the cure or treatment or prevention of disease for animals or humans or (c) is designed to affect the structure or any functions of the human body or any other animal.? To be considered a medical device, and thus subject to FDA regulation, the software must meet at minimum one of these conditions:
- It should be designed to aid to diagnose or treat a patient; or
- It is not intended to alter the structure or function of the body.
If the software you use is designed to be used by health professionals to diagnose treat or manage patient data in hospitals or other healthcare facilities, the FDA is likely to consider the software to be medical devices and subject to regulatory review.
Is Your Software a Medical Device?
FDA’s current oversight, which focuses on functionality more than platform it will ensure that FDA regulates to only medical devices with functionality that could present risks to the safety of patients. Some examples of Device Software and Mobile Medical Apps that FDA is looking at include
- Software functions that aid those suffering from psychiatric disorders diagnosed (e.g., post-traumatic stress disorder (PTSD) or anxiety, depression, obsessive-compulsive disorder) keep their behavioral coping skills by providing a “Skill of the day” behavioral technique or audio messages that the user can use when they are experiencing an increase in anxiety;
- Software functions that provide periodic information on education, reminders, or motivational guidance for smokers who are who are trying to quit, those who are recovering from addiction or pregnant women;
- Software functions that utilize GPS location information to alert asthmatics of environmental conditions which could trigger asthma symptoms, or to notify an addict (substance abusers) in proximity to a specified high-risk or high-risk location.
- Software that utilizes games and videos to motivate people to do their exercise at home.
- Software functions that prompt the user to input which herb and drug they would like to take concurrently and provide information about whether interactions have been seen in the literature as well as an explanation of what kind of interaction was described;
- Software functions that use the characteristics of the patient such as age, sex and risk factors for behavioral health to provide specific screenings for each patient, counseling and preventive advice from well-known and reputable authorities;
- Software functions that make use of an inventory of the most common signs and offer advice about when to see a doctor.
- Software functions allow users to navigate through a questionnaire about their symptoms and then make a recommendation on the best type of medical facility to treat their needs.
- Mobile applications that are designed to enable users to initiate a nurse call or emergency call by using broadband or cell phone technology.
- Apps that allow patients or caregivers to notify emergency situations to first responders through mobile phones
- Software functions keep track of medication and offer user-configured reminders to improve drug adherence
- Software functions allow users access to their health information. This can include historical trends and comparisons of vital signs (e.g. body temperature heart rate, blood pressure).
- Software functions that aggregate and display trends in personal health incidents (e.g. alert notification rates or hospitalization rates);
- Software tools permit users to either manually or electronically input blood pressure information, to share it via e-mail, track it and trend it, and then upload it to an electronic or personal health record.
- Mobile applications that give reminders about oral health or monitoring tools for people suffering from gum disease.
- Mobile apps provide prediabetes patients with guidance or tools that can help them develop better eating habits or increase their physical exercise;
- Applications that permit users to display pictures and other messages on their mobile devices, which could be utilized by users of drugs who wish to end their addiction.
- Software functions that report drug-drug interactions as well as relevant safety information (side effects and drug interactions active ingredient) in a report that is based on demographic information (age and gender), clinical data (current diagnosis), and current medications as well as
- Software functions that allow the surgeon to have an inventory of intraocular lens strengths and the recommended axis of implantation based on information provided by the surgeon (e.g. the expected surgically-induced astigmatism that is likely to occur, patient’s axial length and cornea astigmatism prior to surgery, etc.)
- Applications, mostly mobile, that transforms mobile platforms into medical devices that are regulated.
- Software that connects with an mobile platform using a sensor or lead to measure and display electrical signals generated by the heart (electrocardiograph; ECG).
- Software that connects a sensor to the mobile platform, or any other tool within the platform, that allow users to see or record eye movements to identify balance issues
- Software that questions potential donors about their history with donors and their records and/or sends those answers to the blood collection facility. This program is used to determine whether a donor is eligible to collect blood or any other component.
- Software that connects to an existing device to control the device’s operation, function or power source.
- Software that changes the functions or settings of an infusion pump.
- Software that regulates the inflation and deflation a blood pressure cuff
- Software to calibrate hearing devices and assesses the sound intensity characteristics and electroacoustic frequency of masters hearing aids and group hearing aids.
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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