Software for Surgeons (Menlo Park, CA)
The preferred embodiment of the invention is a computer system for an information log system for medical records. To enter data into various medical log entries, a mouse and/or keyboard is utilized. These log entries are associated with a medical appointment and provide information regarding the doctor and the type. Each medical visit has only one log entry related to it. The information entered is stored in a logical database in the computer’s memory. The computer’s controller is used to keep track of the input data for various information. This includes records keeping and analysis of outcomes, research, teaching, quality assurance, and/or billing. If requested, the input data will be displayed.
These as well as other advantages will be evident to those who are skilled in this field upon a reading of the following detailed description of the invention, which should be taken in conjunction with the drawings accompanying it.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA could refer to functions in software that comprise ” Software As a Medical Device” and “Software in a Medical Device(SiMD)” These is a software function that is integral to (embedded within) a 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 regulator, or other similar or related articles, as well as an accessory or component. . . (b) is intended to diagnose or treat illnesses or other conditions that affect humans or animals. (c) is designed to modify the structure or function of human bodies or animals. To be considered a medical device and therefore subject to FDA regulation, the software must meet at least one of the following requirements:
- It must be intended for use to diagnose or treat a patient; or
- It is to be designed to modify the structure or perform any function of the body
Thus, if your software is designed specifically for healthcare professionals to diagnose and treat patients, or is used in hospitals to manage patient records, the FDA would likely view such programs as medical devices that are 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 more than its platform, FDA will apply its regulation only to devices for medical use that possess capabilities that could be a risk to patient safety. Some examples of Device Software and Mobile Medical Apps that FDA is focused on include
- Software functions that aid patients with diagnosed psychiatric conditions (e.g. post-traumatic stress disorder (PTSD), anxiety, depression, obsessive compulsive disorder) retain their ability to cope by offering an “Skill of the day” behavior technique or audio-based messages users can access when experiencing increased anxiety;
- Software functions provide periodic reminders, motivational advice as well as educational information for patients recovering from addiction or smokers looking to quit;
- Software functions that utilize GPS location data to warn asthmatics when they’re near high-risk locations (substance abusers) or to warn asthmatics to possible environmental conditions that may trigger symptoms.
- Software that makes use of games and videos to motivate patients to take part in exercise at home.
- Software functions that require users to select which herb and drug they wish to take simultaneously and give information on whether interactions have been observed in the literature as well as a summary of what type of interaction was described;
- Software functions that take into account specific characteristics of patients, such as gender age, gender, as well as risk factors, in order to provide specific counseling, screening and prevention advice from well-established and respected experts.
- Software functions that utilize an inventory of the most common symptoms and signs to provide the possibility of medical conditions and advice on when to consult an expert in health care;
- Software functions allow users to answer a survey regarding symptoms and give a recommendation for the most suitable medical facility to treat the patient.
- The mobile apps enable users to make pre-determined nurse calls, or emergency calls, using cell phone or broadband technology.
- Mobile apps that enable the patient or caregiver to create and send an alarm or general emergency alert to first responders.
- Software that tracks medication and offers user-configured reminders to improve medication adherence.
- Software functions give users access to their health records. This includes historical trending and the comparison of vital indicators (e.g. body temperature, heart rate, or blood pressure).
- Software functions that aggregate and display trends in personal health incidents (e.g. hospitalization rates , alert notification rates);
- Software functions permit users to electronically or manually input blood pressure data, and to share it with e-mail as well as track and track it, and then upload it into an electronic or personal health record.
- Apps that provide mobile applications for tracking and reminders about oral health. They also provide devices to monitor users who suffer from gum disease.
- Apps that give mobile users access to information and tools for prediabetes patients;
- Apps that allow users to display pictures and other messages on their mobile devices. These apps can be used by substance abusers who want to stop their addiction.
- Software functions that offer drug-drug interactions and relevant information about safety (side effects or drug interactions and active ingredient) as a report that is based on demographic information (age, gender), medical data (current diagnosis) and current medications; and
- Software functions that give the surgeon an inventory of intraocular lens strengths and the recommended an axis for implantation based upon information supplied by the surgeon (e.g. the expected surgically-induced astigmatism that is likely to occur, length of the patient’s axial and corneal astigmatism prior to surgery, etc.)
- Software, usually mobile apps transforms mobile platforms into a regulated medical device.
- Software that is connected to mobile platforms using a sensor or a lead that measures and displays the electrical signals produced by the heart (electrocardiograph, ECG).
- Software that connects a sensor or other device to the mobile device to observe eye movements to diagnose balance issues.
- Software that collects data about potential donors and transmits it to an institution for blood collection. This software determines the eligibility of a potential donor to collect blood or other components.
- Software that is connected to an existing device to control the device’s operation, function or power source.
- Software that modifies or disables the functions of an infusion pumps
- Software that regulates the inflation or deflation a blood pressure cuff
- Software to calibrate hearing aids and analyzes the sound 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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