Welch Allyn, Inc. (Skaneateles Falls, NY)

The invention is a system and method for the reporting of health status for patients. One aspect of the invention is a method of assigning attention to health care staff to events or issues that affect patients who are in a health center. In some embodiments, assignment of health care personnel to patients receiving health care may be determined based on a set of directives. The directives can direct assigning personnel based on many criteria including, but not limited to, the identity and/or location the patient in need of health care as well as an event or issue associated with the status of the health care patient, the availability of other health professionals to address the situation or issue or a combination of the two.

A variety of health care equipment for reporting status, like those reporting a physiological status and/or the location of a health care patient and are designed to transmit status information to those within visually or auditory distance of the patient, or to areas that are further distances from the health care patient. The status information is received by health professionals who will respond.

The invention offers a system and method for reporting the status and health of patients in the healthcare sector. One aspect of the invention is a method for giving attention to health professionals to events or issues associated with patients at a health facility. A set of directives can be used to control the assignments of health care personnel to patients. The directives can direct employees to be assigned based on various criteria, including but not limited to, the identity or location of a health care patient and/or an event associated with the status of the health care patient, the ability of other health care personnel to attend to the event or issue, or a combination of these.

You will see the benefits of the invention, along with the aspects, objects, features and other advantages, in the following description and in the claim.

Click here to view the patent on USPTO website.

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What is a software medical device?

The FDA may refer to the functions of software that comprise ” Software As a Medical Device” and “Software in a Medical Device(SiMD)” that are programs that are integral (embedded within) a medical device.

Section 201(h) of the Federal Food, Drug, and Cosmetic Act ?21 U.S.C. 321(h)(1), defines an medical device as an instrument, apparatus, device an instrument, device, implant an in vitro reagent or any other similar or related article, including a component or accessory that is . . . (b) designed for use for the diagnosis of diseases or other conditions, or in the cure or treatment or prevention of diseases in animals or man or (c) is designed to affect the structure or function of the body of man or other animals.? To be classified as a medical device and therefore subject to FDA regulation, the software must meet at least one of the following criteria:

  • It must be designed for diagnosing or treating patients; or
  • It must be designed to affect the structure or perform any function of the body

Therefore, if your program is specifically designed for health professionals to diagnose and treat patients or is used by hospitals to handle patient data, the FDA would likely view such software as medical devices subject to review by regulators.

Is Your Software a Medical Device?

The current FDA oversight process, which puts more emphasis on the functionality of the software than the platform, will ensure that FDA does not regulate medical devices with functionality that could be dangerous for patient safety. Some examples of Device Software and Mobile Medical Apps that FDA is focused on includes

  • Software functions that help patients suffering from diagnosed mental disorders (e.g. depression, anxiety, post-traumatic stress disorder (PTSD), etc.) by offering “Skill of the Day”, a behavioral technique, or audio messages, that the user can access when feeling anxious.
  • Software functions that offer periodic reminders, motivational advice and information on education to those recovering from addiction or who are trying to quit.
  • Software functions that make use of GPS location data to warn asthmatics of environmental conditions that may cause asthma symptoms or alert an addiction patient (substance abusers) in proximity to a specified, high-risk location;
  • Software functions that make use of video and video games to inspire patients to perform their exercise routines at home;
  • Software functions that require users to select which herb and drug they would like to take in conjunction and offer information about the likelihood of interactions being reported in the literature and an explanation of the kind of interaction was described;
  • Software functions that consider patient characteristics, such as gender age, gender, and other risk factors, to provide specific counseling, screening and preventive advice from established and highly-respected experts.
  • Software functions that make use of an inventory of the most common signs and symptoms to provide a list of possible medical conditions , as well as advice on when to consult the health professional;
  • Software functions that help users to complete a questionnaire about their symptoms and then give a recommendation for the most suitable healthcare facility for the patient.
  • These mobile apps allow users to make pre-defined nurse calls or emergency calls with cell phone or broadband technology.
  • Apps that allow caregivers or patients to notify emergency situations to first responders through mobile phones
  • Software functions keep track of medications and provide user-configured reminders to ensure better compliance with medication;
  • Software functions allow patients access to their health information. This includes historical trends and comparisons of vital signs (e.g. body temperature, heart rate, or blood pressure).
  • Software functions that reveal trends in personal healthcare incidents (e.g. hospitalization rates or alert notification rates)
  • Software functions allow the user to gather (electronically or manually input) blood pressure information and share this data through e-mail, track and trend it, or upload it into a personal or electronic health record.
  • Apps that provide mobile applications to monitor and remind you about oral health or tools to track those suffering from gum disease.
  • Apps that give mobile users access to information and other tools for patients with prediabetes;
  • Mobile apps that display when appropriate messages or images to a user of a substance who would like to quit their addictive behavior;
  • Software functions that report drug-drug interactions as well as relevant information about safety (side effects or drug interactions, active ingredient) in a report based on demographics (age, gender) and clinical data (current diagnosis), and current medications as well as
  • Software functions that provide the surgeon with an inventory of intraocular lens powers and recommended the axis of implantation, based on information inputted by the surgeon (e.g., predicted surgically induced astigmatism patient’s axial length , corneal astigmatism prior to surgery, etc.)
  • Software, mostly mobile apps, converts a mobile platform into a regulated medical device.
  • Software that can be connected to a mobile device using a sensor or a lead that measures and displays the electrical signals generated by the heart (electrocardiograph, ECG).
  • Software that attaches sensors or other instruments to the mobile device to observe the eye’s movements to identify balance issues
  • Software that questions potential donors about their history with donors and their records and then sends those answers to the blood collection facility. The software can determine the eligibility of a potential donor to donate blood or any other component.
  • Software that is connected to an existing device to control its operation, function or energy source.
  • Software that alters or blocks the functions of an infusion pumps
  • Software that regulates inflation or deflation a blood pressure cuff
  • Software that is used to calibrate hearing devices and assess the electroacoustic frequencies, audio intensity characteristics, as well as 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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