First Opinion Corporation (La Jolla, CA)
What is a Software Medical Device for Computerized medical diagnosis and treatment advice system, with network access
1. Field of the Invention
The invention is related to medical knowledge systems, and specifically, to systems for giving medical advice to the general population through networks.
2. Description of the Technology Technology
The current costs of health care represent 14% of the Gross National Product of the United States and are increasing more quickly than any other component of the Consumer Price Index. Many people are also denied basic information and medical treatment due to the fact that they can’t pay for them.
A lot of people are delayed in seeking or seeking medical attention due to cost or time limitations or other inconveniences. Many illnesses could be avoided when the general public had access to an easy, cost-free, and unrestricted access to medical information. Early diagnosis and treatment of many diseases could stop many patients from entering the most serious stages. This would reduce the burden on our health system which can lead to significant financial hardships. The United States faces health-related problems in huge numbers and the solutions currently in place aren’t robust enough.
Ask-A-Nurse is a previous attempt to resolve the issue of healthcare. This involves a group nursing professionals who provide information via telephone round-the-clock. A person with a medical problem calls an 800 number and describes the issue to the nurse. The nurse utilizes computers to gather general or diagnostic information on the condition or complaint described by the person calling. The nurse will then be able to refer the patient to a physician from a computerized referral list for a hospital that contracts with a group of hospitals. Ask-A-Nurse provides hospital referrals for patients to the hospitals of their clients. The managed care option known as Personal Health Advisor is similar and adds the capability for the user to receive recorded messages about health issues throughout the day.Several issues are associated with these earlier medical advice systems. The first is that they come with high costs due to having a nurse take each telephone call. To be able to use the service, the person calling may have to be a member of a health plan with a participation. Third, if for some reason all nurses on one shift are busy and the caller has an emergency issue (that is not known by the caller to be an emergency) the time spent receiving emergency assistance could be lost due to the delay.
Another prior health system was designed by InterPractice Systems which provides a computer-based service that addresses health care questions and advises individuals at home. This service may be provided by a health care organization (HMO), to its members within a specific geographical area. An HMO member is able to connect a small , toaster-sized unit and a telephone for help at home. Utilizing a keyboard inside the box, the user can answer questions on a screenof the box relating to the user’s symptoms. The answers determine if the user is advised to use a home remedy or to call a doctor or nurse. The only downside to this approach is the cost associated with the box. It could be purchased by consumers for around $300, or it could be purchased by the health care provider and transferred to clients. Another limitation is that this service is directed to members of a particularcontracting health organization, such as an HMO. What is needed is an option that doesn’t require additional hardware for the basic service, but that makes use of the existing network for communication. The system that is desired should be available for use by anyone, not only individuals belonging to a particular group.
U.S. Pat. describes an earlier effort to provide healthcare solutions to a restricted set of circumstances. No. 4,712,562. The blood pressure of a patient and heart rate are monitored and transferred via phone to a central computer remote for storage and analysis. In order to be sent to a physician or patient, reports are prepared. U.S. Pat. No. 4,531,527 describes a similar system, wherein the receiving office unit automatically communicates with the physician under predeterminedemergency circumstances.
U.S. Pat. No. 4,838,275 is a patent describing a device designed for a patient to lay on or sit in that has electronic devices that can measure multiple aspects of the health of the patient. The health data of the patient are transmitted electronically to a central control office where a highly-trained observer is in contact with. Patient initiates communication if an emergency is being noted. The observer decides if it is necessary to initiate a non-routine therapeutic response, and if so facilitates such a response. As we’ve mentioned before that highly trained individuals are required by this system along with the special measuring apparatus (embedded in chairs or a bed).
U.S. Patent. No. 5,012,411 that describes a portable, self-contained device to measure, store and transmitting physiological data to a distant location using an electronic communication system. The data is analyzed by a doctor or other health professional. The device can only be used by highly-trained people, just like before.
Several services to provide medical or pharmaceutical advice are now available via “1-900” telephone numbers, e.g., “Doctors via Phone.” These services are available 24/7 and seven days a week. For anyone located in the United States, a group of doctors including some specialties is available to answer all questions related to health care or medical conditions. A team of pharmacists registered responds to questions regarding medications for the “1-900” pharmaceutical service.Click here to view the patent on USPTO website.
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What is a software medical device?
Is Your Software a Medical Device?
As per FDA’s current oversight approach, which considers the functionality of the software higher than its platform, FDA will apply its regulation only to medical devices with functions that be a risk to patient safety. Some examples of Device Software and Mobile Medical Apps that FDA is focused on include
- Software functions to aid patients with diagnosed mental disorders (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) by providing “Skill of the Day” an approach to behavior, or audio messages, that users is able to access when experiencing anxiety.
- Software functions that offer periodic educational information, reminders, or motivational tips for smokers who want to quit, who are recovering from addiction or pregnancies women;
- Software functions that make use of GPS location information to alert asthmatics to environmental conditions that could trigger asthma symptoms, or to notify an addict (substance addicts) in proximity to a specified high-risk or high-risk location.
- Software functions that employ video and video games to motivate patients to do their exercise routines at home;
- Software functions let users choose the medicine or substance they want to take at the same time. They also give information on interactions and provide a summary of the type of interaction.
- Software functions that take into account specific characteristics of patients, like gender age, gender, and other risk factors, to provide specific counseling, screening and prevention advice from well-established and respected authorities.
- Software functions that utilize an inventory of typical symptoms and signs to give guidance on when it is appropriate to see an ophthalmologist and what you should do next.
- Software functions that help users to complete a questionnaire about their symptoms and then give a recommendation for the most suitable health care facility for the patient.
- These mobile applications allow users to make nurse calls or emergency calls using technology like cell phones or broadband.
- Mobile applications that permit patients or their caregivers to create and transmit an alert or general emergency notification to emergency responders.
- Software that tracks medication and provides user-configurable reminders to improve medication adherence.
- Software functions that provide patients with a way to access their personal health records for example, access to the information gathered during a prior visit to a doctor or historical trending and comparison of vital signs (e.g. body temperature, blood pressure, heart rate or respiratory rate);
- Software functions that aggregate and show patterns in health-related incidents that affect individuals (e.g., rate of hospitalization or alert notification);
- Software tools allow users to either manually or electronically enter blood pressure information, to share it with e-mail, track it and trend it, then upload it into an electronic or personal health record.
- Mobile apps that offer oral health reminders and tracking tools for users with gum disease;
- Mobile apps give patients suffering from prediabetes advice or tools to help them establish better eating habits or increase their physical exercise;
- Mobile applications that display, at opportune times pictures or other messages to those who abuse substances and want to get rid of addiction;
- Software functions that give drug interaction and safety information (side effects and interactions with drugs active ingredient active ingredient) in reports based on information about demographics (age and gender) and current diagnosis (current medication), and clinical information (current treatment).
- Software functions that enable surgeons to identify the best intraocular lens powers for the patient and the direction of the implantation. This information is determined by the surgeon’s inputs (e.g. the expected surgically induced astigmatism and patient’s axial length, prior to surgery cornea astigmatism, etc.).
- Software, typically mobile apps that converts a mobile platform to a regulated medical device.
- Software that is connected to a mobile platform using a sensor or a lead to measure and display the electrical signals generated by 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 the eye movements to detect balance disorders
- Software that gathers information about potential donors and sends it to a blood collection facility. The software will determine whether a person is eligible to receive blood or other components.
- Software that connects to an existing device in order to regulate its function, operation, or energy source.
- Software that changes the settings or function of an infusion pump
- Software that controls the deflation or inflation of a blood pressure Cuff
- Software used to calibrate hearing aids and to evaluate the electroacoustic frequencies, sound intensity characteristics, and coming from 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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