International Business Machines Corporation (Armonk, NY)
What is a Software Medical Device for Picture encoding apparatus to block area wavelet transformation
1. Technical Field
The invention is a method and method for providing advertising in web-based printing. Particularly, the present invention relates to a method and system to provide free or subsidised printing in exchange foradvertising spaces in printed publications.
2. Description of Related Art
The use of remote printing for electronic documents is increasing as more computer users make use of their devices away from their offices and homes. More portability for laptop computers, and other devices that are ubiquitous in computing such as personal digital assistants (PDAs), mobile telephones that connect to the Internet and other wireless networks, and other portable devices mean that more users are using computing devices when traveling.
One item that is usually difficult for people to take with them while traveling is a printing device. While some portable printers are on the market, these printers are usually challenged by slower print speeds and poor document handlingcapabilities. For example, the user may have to feed individual sheets into the printer on the go and wait for several seconds or even minutes before receiving a printout. Furthermore, portable printers tend to not be as portable as portablecomputing devices. Portable printers are usually between 9 and 12 inches long and several inches wide, making it difficult to carry the device.
The users of portable computing devices frequently find electronic documents they’d like to print. Locations that are frequented by tourists like airports, hotels, and copy centers, usually have business services available for an additional cost. The user canuse the facilities for business use, which include devices such as printers, computers, monitors or facsimile machines as well as copiers and are generally charged an hourly fee. If users are only required to print a document on their smartphones and printers, they might not be willing to pay an hourly cost for equipment used by businesses.
Certain travel services like hotels or copy-service, permit customers to print from their printers and pay a fee for printing usually a specific amount per page. For document drafts and other informal documents, users are often resistant to paying a high cost for such casual printouts.
Advertisers are increasingly using electronic advertisements, such as banners on Internet web pages to draw users. Advertisers spend a great deal of money and effort in discovering the target audience of Internet users. For instance, a site that is focused on medical equipment that is frequently visited by medical doctors may host additional advertisements for other medical-related goods and services. For instance, a manufacturer of medical software may purchase advertising space on the medicalequipment web site in an effort to attract new customers. One of the problems with Internet ads is that they are only visible for a brief period of time to the user. Users may lose the information when they change screens or visit another website. They may not remember how to reach the advertiser in case they do not keep the information in a safe place or write it down.
What is needed, therefore is a way to combine the goals of advertisers of identifying and targeting groups of users, with the users’ desire to print documents while on the move.
Advertisements can be printed on remote printers, as per new research. Advertisers sign up to advertise to the general public or to certain user groups. When a user is traveling and needs to print adocument using a remote printer (i.e. the airport, hotel, copy service printer, etc. He will be asked about his work and other characteristics of his own. These information are used to select the advertising that is the most suitable for the individual. The user can request to print documents electronically. The selected advertisements will be printed in the printed document.
The host site for the printer (i.e. hotel, airport, or copy service) is paid by the advertisers for including the advertisers advertising in prints. Advertisers would prefer to pay on an image basis. Basically, the hosting site receives a specific amount for every image displayed to a potential customer. Hosting companies may be encouraged to offer printing services for a lower or no cost to customers who include advertisements in their prints. Other criteria may be considered by the hosting company, such as printing documents that are up to a page in length for free if ads are included. They may also charge a cost for large prints. This could increase their printer’s throughput and allow them to earn more money.
This summary contains simplifications, generalizations and absences. Those experienced in the field will realize the fact that this description is illustrations and is not intended to be restrictive. The more detailed description below will reveal other aspects, inventive features and benefits of the invention in the manner they are described in the claims.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA refers to software functions that can include ” Software as a Medical Device” (SaMD) and “Software in a Medical Device (SiMD) ), which is software that is part of (embedded in) an medical device.
Section 201(h),?21 U.S.C. 321(h)(1), defines the term “medical device” as instrument, apparatus, device, machine, contrivance implant or in vitro reagent or other similar or related device, including a component or accessory, which is . . . (b) is intended to treat or diagnose illnesses or other conditions that affect animals or humans. (c) is designed to modify the structure or function of the human body or animal. To be classified as a medical device and therefore subject to FDA regulations the software must meet the minimum of the following requirements:
- It must be intended to be used in diagnosing or treating a patient; or
- It is not intended to modify the structure or purpose of the body.
So, if your application is specifically designed for healthcare professionals to diagnose and treat patients or used in hospitals to manage patient records The FDA will likely consider such software as medical devices that are subject to review by regulators.
Is Your Software a Medical Device?
According to FDA’s current oversight approach which considers the capabilities of the software higher than its device’s platform, FDA will apply its regulation only to medical devices that have functionality that could be a risk to patient safety. Examples of Device Software and Mobile Medical Apps that FDA is focusing on include
- Software functions to aid those suffering from mental illness (e.g., anxiety, depression, post-traumatic stress disorder (PTSD) for instance.) by offering “Skill of the Day”, a behavioral technique, or audio messages, which the user can access when suffering from anxiety.
- Software functions that provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnancies women;
- Software functions that make use of GPS location information to notify asthmatics to environmental conditions that may cause asthma symptoms, or to notify an addict (substance users) in proximity to a specified, high-risk location;
- Software functions that use video and games in order to motivate patients to complete their exercises in their own homes;
- Software functions that prompt a user to enter which drug and herb they’d like to use simultaneously and give information on whether interactions have been observed in the literature and an overview of the type of interaction was described;
- Software functions that take into account patient characteristics, such as gender, age, and risk factors, to offer individual counseling, screening and preventive advice from established and well-respected experts.
- Software functions that make use of a checklist of common signs and symptoms to provide the possibility of health conditions and advise on when to see an expert in health care;
- Software functions allow users to navigate through a questionnaire regarding symptoms and give a recommendation for the best type of healthcare facility for their needs.
- The mobile apps enable users to make nurse calls, or emergency calls using broadband or cell phone technology.
- Apps that permit patients or caregivers to communicate emergency alerts to first responders via mobile phones
- Software functions that track the use of medicines and give users user-defined reminders for better medication adherence;
- Software functions that give patients access to their health records. This can include historical trends and comparisons of vital sign (e.g. body temperature and heart rate pressure).
- Software functions that aggregate and show trends in personal health incidents (e.g. hospitalization rates or alert notification rates);
- Software features permit users to electronically or manually enter blood pressure information, to send it out via email as well as track and track it, and upload it into an electronic health record.
- Mobile apps that allow for tracking and reminders about oral health, or devices to monitor users who suffer from gum disease.
- Apps that offer mobile guidance and tools for prediabetes patients;
- Mobile applications that display when appropriate, images or other messages to a user of a substance who wants to stop addictive behavior;
- Software functions that offer drug-drug interactions as well as relevant information on safety (side effects or interactions between drugs, active ingredient) as a report that is based on demographic information (age, gender) and medical data (current diagnosis), and current medications; and
- Software functions allow the surgeon to have a list of recommended intraocular lens powers and recommended the axis of implantation, based on information inputted by the surgeon (e.g., anticipated surgically induced astigmatism, the length of the patient’s axial axis and preoperative corneal astigmatism, etc.)
- Mobile apps, typically software that convert a mobile platform into a medical device that is regulated.
- Software that is connected to an mobile platform using an instrument or lead to display and measure electrical signals from the heart (electrocardiograph; ECG).
- Software that attaches a camera to the mobile platform or other tools in the platform, to view or record eye movements to detect balance issues
- Software that gathers data about potential donors and transmits it to an institution for blood collection. The software will determine whether a person is eligible to donate blood or other components.
- Software that is connected to an existing device to regulate its function, operation, or energy source.
- Software that alters or blocks the functions of an infusion pump.
- Software that regulates the inflation and deflation a blood pressure cuff
- Software that calibrates hearing devices and evaluates the sound intensity characteristics and electroacoustic frequency of hearing aids, 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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