LMG 3 Marketing and Development Corporation (Hillsdale, NJ)
What is a Software Medical Device for Portable memory device for maintaining the medical history of an individual
This invention relates to the creation of a portable device with security for storing and accessing patient records.
Accessible, accurate and easily shared health information is a widely recognized requirement for good health. Insufficient quality information on health can adversely impact patient safety as well as public safety and the continuity of care for patients. Prior art has tried to resolve these issues in the healthcare field but not in a satisfactory manner. These patents illustrate of the prior art attempts to record medical information.
U.S. Pat. No. 5,832,488 to Eberhardt discloses an electronic system and method of programming data of an individual’s medical histories on a storage device. The programs are intended to store information on smart cards like patient identifier and a running medical history plus pharmaceutical information. U.S. Pat. No. 6,467,690 to Reeves discloses an electronic memory card of a particular type which is capable of having digital binary information stored on its surface. It can be easily carried by one’s person in a wallet or purse.
U.S. Pat. No. No. 5,731,629 to Woodward discloses an electronic personal data storage device that stores data, like medical records, and an apparatus for reading and storing this data from the storage unit.
Of particular importance is U.S. Pat. Nos. 5,932,759 as well as 5,825,882 patent publications 2002/0128856 and 2002/0120470.
Recently, an attempt was made to embed a 32 k chip under the skin of a person with patient information that was uploaded to the chip. The significant disadvantage to this method was that it required surgery that had a an expense and the information on the chip was not as extensive. Moreover, the filing of the original patent application (Ser. No. 10/605,127) of this patent application, other solutions have been suggested such as those presented in published Canadian Patent Application Serial No. 2,545,131. The patent reference is herein incorporated as a reference.
The unique device in this invention is not described or suggested in the prior art and provides a novel solution to the problem of medical records.
This invention is comprised of an portable self-contained, secure, and safe memory device, which is compatible with MyRECS.TM. The software is copyright protected and is able to store information, update, and display personal medical data. MyRECS.TM. device is a small , hand-carried device which is connectible to the USB port of a computer or reader adapter. Access to the medical information is provided by a unique password. Medical information stored in the device can’t be erased or altered, it can only be added.
The MyRECS.TM. It stores personal information as well as emergency contact details. It also holds reports and referral letters, as well as images. Images, reports medications, immunizations, allergies, medical conditions, surgery, alerts, and other pertinent information. Every device is assigned to a specific person and all information is stored in a safe encrypted database. If an emergency occurs, and the user is incapacitated, an 800 number could be used to unlockthe device and look over the information.
Therefore, the purpose of this invention is to offer a new and improved small portable memory device that can be used for the storage of medical records.
Another purpose of this invention is to offer an improved and new portable, safe self-contained memory device which works with software to store, update and display your personal medical data.
A further object of this invention is to provide a new and improved portable device to store medical records that can be accessable through a unique password however it is also able to be opened during emergencies by calling a customer service 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 data. The password cannot be removed, but only added. It may also be used to scan, type into or download.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA refers to functions in software that can include ” Software as a Medical Device” (SaMD) and “Software in a Medical Device (SiMD) ), which is software that is integral to (embedded in) an medical device.
Section 201(h),?21 U.S.C. 321(h)(1) defines an medical device as an instrument, apparatus, implement, machine, contrivance implant or in vitro reagent or other similar or related item, which includes accessories or components that is . . . (b) is intended to be used in the diagnosis of disease or other conditions, or for the cure or treatment or prevention of disease for animals or humans or (c) designed to alter the structure or the function of the human body or any other animal.? To be classified as a medical device and consequently subject to FDA regulations, the software must meet at least one of these requirements:
- It should be used for diagnosing and treating patients.
- It should not be designed to alter the structure or the function of the body.
If your program is intended to be utilized by healthcare professionals to diagnose, treat or manage patient data in hospitals, the FDA will likely consider such software to be medical devices that are subject to review under the regulations.
Is Your Software a Medical Device?
In accordance with FDA’s current oversight strategy that looks at the capabilities of the software more than its device’s platform, FDA will apply its supervision only to medical devices that have capabilities that be a risk to the safety of patients. Some examples of Device Software and Mobile Medical Apps FDA is focusing on
- Software functions that aid those suffering from mental illness (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD) for instance.) by offering “Skill of the Day” or a behavioral strategy, or audio messages, that the user can access when experiencing anxiety.
- Software functions that offer periodic educational information, reminders, or motivational tips to smokers seeking to quit, addicts recovering from addiction, or pregnant women;
- Software functions that utilize GPS location information to notify asthmatics of environmental conditions that could trigger asthma symptoms or alert an addiction patient (substance users) when near a pre-identified high-risk or high-risk area.
- Software that uses video and games to encourage people to do their take part in exercise at home.
- Software functions which let users choose the medicine or substance they want to consume at the same time. They also provide details about interactions , and provide a summary of the type of interaction reported.
- Software functions that are able to take into consideration patient characteristics, such as gender, age, and risk factors, to offer specific counseling, screening and preventive advice from well-known and well-respected experts.
- Software functions that make use of a list of typical signs and symptoms to provide the possibility of having medical conditions , as well as advice on when it is appropriate to speak with the health professional;
- Software functions guide a user through an assessment of their symptoms and signs to give a recommendation for the type of health care facility suitable for their needs.
- Mobile applications are designed to let users make a pre-determined nurse call or emergency call using broadband or mobile phone technology;
- Mobile apps that allow the patient or caregiver to create and send an alert or general emergency notification to emergency responders.
- Software that monitors medications and gives user-configured reminders to increase medication adherence.
- Software functions allow users access to their health records. This can include historical trending as well as comparisons of vital indicators (e.g. body temperature, heart rate or blood pressure).
- Software functions that reveal patterns in personal health incidents (e.g. hospitalization rates or alert notification rates)
- Software functions permit users to electronically or manually enter blood pressure data, to send it out via email or track it, and then trend it, and upload it into an electronic health record.
- Apps that provide mobile applications for tracking and reminders regarding oral health, or tools to track users suffering from gum disease.
- Apps that provide mobile access and other tools for patients with prediabetes;
- Apps that let users display pictures and other messages on mobile devices. These apps are a great option for addicts looking to end their addiction.
- Software functions that report interactions between drugs and other medications as well as relevant information about safety (side effects, drug interactions and active ingredient) in a report based on demographics (age and gender) and medical information (current diagnosis), and current medications; and
- Software functions allow the surgeon to have the list of suggested intraocular lens power and suggested an axis for implantation based upon the information provided by the surgeon (e.g. an expected surgically-induced astigmatism that is likely to occur, the length of the patient’s axial axis and corneal astigmatism before surgery, etc.)
- Software, usually mobile apps transforms mobile platforms into a regulated medical device.
- Software that connects with an mobile platform using an instrument or lead to measure and display electrical signals from the heart (electrocardiograph; ECG).
- Software that connects sensors to the mobile platform or any other tool within the platform, to view, record, and analyze the eye movements to identify balance issues
- Software that collects information about potential donors and sends it to a blood collection facility. The software helps determine if a potential donor is eligible before collecting blood or any other component.
- Software that is connected to an existing device type to control its operation function, or energy source.
- Software that alters or deactivates the functions of an infusion pump
- Software that regulates the deflation or inflation of the blood pressure cuff
- Software used to calibrate hearing devices and evaluate the electroacoustic frequencyand sound intensity characteristics, and sound quality of hearing aids master hearing aids, group hearing aids, or auditory trainers in groups.
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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