International Business Machines Corporation (Armonk, NY)
What is a Software Medical Device for Method and system for advertising for printing on web-based printers
1. Technical Field
The present invention is related to a method and system for providing advertisements in web-based printing. The invention is specifically focused on a system and method of offering printing for free or at a reduced cost in exchange for advertising space in printed documents.
2. Description of Related Art
Remote printing of electronic documents is increasing as more computer users use their computing devices away from their homes and offices. More portability for computers, like laptop computers, as well as other ubiquitous computing devices like personal digital assistants (PDAs), mobile telephones that can access the Internet and other networks wirelessly, and other portable devices means that more users are using computers when traveling.
One gadget that is typically difficult for people to take when traveling is a printer. While some portable printers are on the market, these printers are usually challenged by slower print speeds and poor document handlingcapabilities. For instance, the user may have to feed individual sheets into the printer on the go and wait for a few seconds, or even minutes, before receiving a printout. Portable printers aren’t as portable as other devices for computing on the go. The majority of portable printers are at least 9 to 12 inches in length and several inches wide, which makes it difficult to transport the device.
A lot of people who use portable computing devices can identify electronic documents that they want to print. Numerous places where travelers are frequent like airports or hotels, provide business services for a nominal fee. Users can use the facilities of business services, including equipment like printers, computers, monitors or facsimile machines as well as copiers. They are usually charged an hourly rate. It is possible that users are hesitant to paying hourly charges for equipment for business even though all they have to do is print out an image from their portable electronic device.
Certain travel agencies, such as a hotel or copy-service, permit users to print using their printers and pay a printing fee, often a certain quantity per page. For document drafts as well as other non-formal documents people are usually hesitant topaying an often high rate for printouts that are not formal.
To draw customers in advertising, they increasingly employ online forms, such as banners that are placed on Internet pages to promote their products. Advertisers spend a significant amount of money and time the targeting of particular groups of Internet users. A website dealing with medical equipment might contain additional ads related to medical products and services. For example, a supplier of medical software may buy advertising space on the medicalequipment web site in an effort to attract new customers. The problem with Internet based advertisements is that they are only visible for a brief time to the user. When a user switches screens or visits another web page, they are unable to remember the details. They may not remember how to contact the advertiser if they do not keep the information in a safe place or write it down.
It is therefore necessary to mix the needs of advertisers of targeting specific groups of users with the needs of those who have to print their documents.
It has been discovered that advertisements are placed on printouts that are requested by remote printer users. Advertisers sign up to market to the general population or to certain user groups. A user needs to print documents on an external printer when the user is away from his home (e.g. or at an airport, hotel, or printing with a copy printer service). He will be asked about his job and other personal characteristics. These information are used to determine which advertisement is most appropriate for the individual. The user can request to print documents electronically. The advertisements that are selected will be included within the printed document.
The host site for the printer (i.e. the airport, hotel, copy service) is compensated by advertisers for the use of the advertisers ads in printouts. Advertisers prefer to pay according to the image. Hosting sites receive a certain amount of money for each image shown to potential customers. Because of the economic incentive, hosting sites may be allowed to print documents for free or at a significantly lower cost if advertisements are included in printouts. Other criteria could be used by the hosting website for example, printing documents that are up to 1 page in length for free if ads are printed. They might also charge a fee for large printouts. This could boost the speed of their printers and help them make more money.
This summary contains simplifications, generalizations and absences. People who are experienced in the field will recognize that this summary is merely an illustration and is not intended to be limiting. The more detailed explanation below will provide additional aspects, innovative features, and the advantages of the invention in the manner they are defined in the claims.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA is referring to the functions of software that may comprise ” Software as a Medical Device” (SaMD) and “Software in a Medical Device (SiMD) ), which is software that is integrated into (embedded inside) the medical device.
Section 201(h),?21 U.S.C. 321(h)(1) defines the term “medical device” as instrument, apparatus, device or device, machine, implant, in vitro reagent, or any other similar or related device, which may include a component or accessory that is . . . (b) is intended to diagnose or treat illnesses or other conditions that affect humans or animals. (c) is designed to alter the structure or functions of the human body or animal. To be considered a medical device, and consequently subject to FDA regulation the software must satisfy at least one of the following requirements:
- It must be used in the diagnosis and treatment of patients.
- It is to be designed to alter the structure or function of the body
If the software you use is designed to be utilized by healthcare professionals to diagnose treat or manage patient records in hospitals, the FDA will likely consider such software as medical devices and subject to review by the regulatory authorities.
Is Your Software a Medical Device?
According to FDA’s current approach to oversight that considers the function of the software, rather than its platform, FDA will apply its supervision only to devices for medical use that possess functionality that could be a risk to the safety of patients. Examples of Device Software and Mobile Medical Apps FDA is focused on
- Software functions that help those suffering from psychiatric disorders diagnosed (e.g., post-traumatic stress disorder (PTSD) or depression, anxiety, or obsessive compulsive disorder) retain their strategies for coping by providing the “Skill of the Day” method of behavior or audio messages that the user can access when experiencing increased anxiety;
- Software functions that offer periodic reminders, motivational support and information on education to those recovering from addiction or smokers who are trying to quit.
- Software functions that use GPS location information to alert asthmatics to environmental conditions that could trigger asthma symptoms or warn an addict (substance abusers) in proximity to a specified, high-risk location;
- Software functions that use video and video games to entice patients to perform their physical therapy exercises at home;
- Software functions that prompt users to select which herb and drug they’d like to use concurrently and provide information about the likelihood of interactions being reported in the literature, as well as an overview of the type of interaction was reported;
- Software functions that make use of factors that affect the health of a patient, like age, sex, and behavioral risk factors to provide specific screenings for each patient, counseling and preventive advice from well-known, established experts;
- Software functions that make use of a checklist to determine common symptoms and provide guidance on when to see the doctor.
- Software functions allow users to answer a survey about their symptoms and then give a recommendation for the best type of health care facility for them.
- Mobile apps that are intended to let users initiate a nurse emergency or nurse call by using broadband or cell phone technology;
- Mobile applications that permit patients or their caregivers to create and send an alarm or general emergency message to first responders;
- Software that tracks medication and offers user-defined reminders that help improve the medication’s adherence.
- Software functions that give patients with a way to access their personal health records including access to the information gathered during a prior visit to a doctor or historical trends and comparison of vital signs (e.g. body temperature and blood pressure, heart rate or respiration rate);
- Software functions that show trends in personal health events (e.g. rate of hospitalization or alert notification rates)
- Software tools allow users to either manually or electronically enter blood pressure information, to send it out via email, track it and trend it, and upload it into an electronic or personal health record.
- Mobile apps that allow to track and remind users about oral health, or devices to monitor users who suffer from gum disease.
- Apps that provide mobile access and other tools for patients with prediabetes;
- Applications that permit users to display pictures and other messages on their smartphones, which are a great option for users of drugs who wish to end their addiction.
- Software functions that give safety and drug interaction information (side reactions and interactions with drugs active ingredient, active ingredient) in an analysis based on demographic data (age and gender) and current diagnosis (current medication) as well as clinical information (current treatment).
- Software functions that permit the surgeon to identify the optimal intraocular lens strength for the patient, as well as the orientation of the implant. The information is dependent on inputs from the surgeon (e.g. anticipated surgically induced astigmatism and the length of the patient’s axial axis, preoperative cornea astigmatism, etc.).
- Mobile apps, usually software which convert an app on a mobile device into medical devices that are regulated.
- Software that is connected to a mobile platform with a sensor or lead to measure and display the electrical signals generated by the heart (electrocardiograph, ECG).
- Software that attaches sensors or other tools to the mobile platform to view eye movements in order to identify balance disorders
- Software that collects data about potential donors, and then transmits the information to a blood collection facility. This program determines if a donor is eligible to receive blood or any other component.
- Software that is connected to an existing device for control of its operation, function, or energy source.
- Software that modifies or blocks the functions of an infusion pump.
- Software that regulates the inflation or deflation of the blood pressure cuff
- Software is used to calibrate hearing devices and evaluate the electroacoustic frequencies, the characteristics of sound intensity, and coming 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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