Multum Information Services (Denver, CO)
Two developments have made it increasingly difficult to administer medications safely and efficiently for patients. The first is an increasing number of patients , and the second is the advancement of medical technology making it harder to administer drugs in a safe and efficient manner.
The FDA has approved 9500 prescription drugs in the last 30 years. Additionally, over 100,000 papers on the use of drugs are published each year. The precise and sensitive assessment and measurement of the metabolites of drugs in biological fluids is made possible by major advancements in analytical methodologies. This allows the creation of mathematical parameters that could be used to explain drug metabolism and disposition. Because of the increasing sophistication of pharmacokinetics (how drugs are distributed in the body) It has become feasible to design dosage plans for patients based on the function of an organ. This allows the proper dosage of the therapeutic agent can be calculated.
The kidney and the liver are the two primary ways to eliminate drugs from the body. The organs are responsible for detoxifying and remove substances from the body and when their function is reduced, the accumulation of drug or drug metabolitesmay be observed. A gradual decline in liver and renal function caused by disease or simply by the aging process have been associated with changes in the metabolism of many drugs. Alterations have been demonstrated in absorption, protein binding, distribution,elimination, and metabolism.
This is why the majority of patients suffering from organ dysfunction are receiving medication. Patients with renal failure who require dialysis and 30% of seniors are prescribed eight medications per day. Patients suffering from end-stage kidney disease who are undergoing organ transplantation receive a variety of medications which focus on the immune system to fight infection.
Thus, there is a demand for methods and systems that provide clinicians with quick and easy access to up-to-date, relevant and relevant patient-specific drug information and recommendations for dosing.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)” and are software functions that are integral to (embedded in a) a medical device.
Section 201(h),?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, instrument, machine, contrivances, implant, in vitro regulator, and other related articles, as well as a component or accessory. . . (b) designed for use for the diagnosis of illnesses or other conditions or for the cure or mitigation of disease, or prevention of diseases for animals or humans, or (c) designed to alter the structure or the functions of the human body or any other animal.? Thus, to be considered a medical device, and thus subject to FDA regulation, your program must meet two requirements:
- It must be intended to aid to diagnose or treat a patient; or
- It should not be designed to change the structure or function of the body.
Thus, if your software is specifically designed for health professionals to diagnose and treat patients, or in hospitals to manage patient records, the FDA will likely consider such programs as medical devices subject to review by regulators.
Is Your Software a Medical Device?
The current FDA oversight system, which places more emphasis on the functions of the software than the platform is designed to ensure that FDA doesn’t regulate medical devices with functionality that may pose a risk to the safety of patients. Examples of Device Software and Mobile Medical Apps FDA is focusing on
- Software functions to aid those suffering from mental illness (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD) and others.) by providing “Skill of the Day”, a behavioral technique or audio message that users is able to access when experiencing anxiety.
- Software functions that provide periodic educational information, reminders, or motivational guidance to smokers who want to quit, addicts who are recovering from addiction and pregnant women;
- Software functions that make use of GPS location information to alert asthmatics to environmental conditions that could trigger asthma symptoms or alert an addiction patient (substance abusers) in proximity to a specified high-risk area;
- Software that makes use of games and video to help patients to take part in exercise at home.
- Software functions that ask the user to input the herb or drug they’d like to use in conjunction and offer information on whether interactions have been seen in the literature and an explanation of the kind of interaction was observed;
- Software functions that utilize the characteristics of the patient such as age, sex and other risk factors for behavior to offer specific screening for patients, counseling , and preventive advice from well-known and reputable authorities;
- Software functions that utilize a checklist to identify common symptoms and provide advice about when to see an acupuncturist.
- 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 the patient.
- The mobile apps enable users to make nurse calls or emergency calls using the cell phone or broadband technology.
- Apps that allow patients or caregivers to notify emergency situations to first responders via mobile phones
- Software that tracks medication and gives user-configured reminders to increase medication adherence.
- Software functions that offer patients with access to their own health information, such as access to data gathered at a previous visit to the doctor or historical trending and comparison of vital sign (e.g., body temperature or blood pressure, heart rate or respiration rate);
- Software functions that display trends in personal healthcare events (e.g. hospitalization rates or alert notification rate)
- Software functions that permit the user to collect (electronically or manually input) blood pressure information and transmit this data via email or track and analyze it, or add it into a personal or electronic health record.
- Mobile applications that give dental health reminders, or tools for tracking users suffering from gum disease;
- Mobile apps provide prediabetes patients with guidance or tools to assist them develop better eating habits or increase their physical exercise;
- Apps that let users display pictures and other messages on their smartphones, which are a great option for addicts looking to stop their addiction.
- Software functions that offer interactions between drugs and other medications as well as pertinent safety data (side effects and interactions between drugs and active ingredient) in a report based on demographics (age and gender), medical data (current diagnosis), and current medications; and
- Software functions that allow the surgeon to determine the most effective intraocular lens power for the patient and the axis of implantation. The information is based on surgeon’s inputs (e.g. anticipated astigmatism caused by surgery, the patient’s axial length and cornea astigmatism prior to surgery, etc.).
- Software, usually mobile apps, converts a mobile platform into a medical device that is regulated.
- Software that communicates with the mobile platform through an instrument or lead to display and measure electrical signals generated by the heart (electrocardiograph; ECG).
- Software that connects a sensor to the mobile platform, or any other tool within the platform, to view or record the eye movements in order to diagnose balance disorders
- Software that collects information about potential donors and transmits the information to a blood collection facility. This software is used to determine if a person is eligible for blood collection or any other component.
- Software that connects to devices of the same type in order to regulate the device’s operation, function or power source.
- Software that alters the settings or function of an infusion pump.
- Software that regulates inflation or deflation of a blood pressure cuff
- Software used to calibrate hearing devices and evaluate the electroacoustic frequency, audio intensity characteristics, as well as emanating from 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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