Sony Corporation (Tokyo, JP) Kiya; Hitoshi (Tokyo, JP)
What is a Software Medical Device for Method and apparatus for wavelet inverse transformation and wavelet decoding
1. Field of the Invention
The invention is a wavelet-inverse transformation technique and apparatus that extracts and decodes only transform coefficients from the partial area of waveslet transform coefficients. The invention also relates to a corresponding wavelet code decoding method.
2. Related art description
The ISO (International Organization for Standardization) has standardized an JPEG system (Joint Photographic Experts Group) that can be used as an alternative to the traditional picture compression systems. This system, employing an orthogonal transform,specifically the discrete cosine transform (DCT), is known to furnish a good encoded or decoded picture when a higher number of allocated bits is used. But, if the amount of encoding bits is decreased to more than a certain degree, the distortion of blocks due to DCT becomes outstanding so that subjective degradation is evident. On the other hand, the system that the whole image is divided into several bands with the use of a filter, also known as a filter bank, comprising the combination of a high-pass and the low-pass filter and the encoding process is carried out by switching from one band to the next it is being studied rapidly. Wavelet encoding without block distortion is being considered a promising technique that may replace DCT.
An electronic still camera or video movie, utilizes the JPEG/MPEG format. The system for transformation is the DCT. A wavelet transform-based product is expected to be introduced on the market in the near future. Many research institutes are collaborating to enhance the effectiveness of the encoder. Actually, JPEG 2000, now is being developed by ISO/IEC/JTC1.sub.– SC29/WG1, the same entity as JPEG as a standard format for a standardization of which is set to be issued in December 2000, is felt to be highly promising for the next generation of international standardization system for still pictures. It is almost clear that JPEG 2000 will employ the wavelet transform, not the DCT of JPEG.
The invention addresses the problem of only expanding a part of wavelet reverse transform. That is, the entire wavelet transform coefficients are not read out and decoded, as is done in the conventionaltechnique. This is a major advantage in terms of reducing memory size. In the process of encoding wavelets process, the wavelet transformation must be applied to the whole picture to save and store the generated wavelet transform coefficients briefly in memory. In the decoding phase this is the reverse of the wavelet encoding process is performed, thus necessitating massive memory capacity to store and holding the coefficients of the entire image. The memory capacity has to be increased when the image size increases. Thus, the conventional procedure is not appropriate on a device with an insufficient memory capacity like an electronic still camera, camcorder or PDA.
Recent research has revealed that such a technique can be used to encode the entire object in a block-based manner. This can be done, for example, during the international standardization efforts of JPEG 2000. Partially decoding is possible if the encoder works on block-based bases. Unfortunately, partial decoding without constraints on the encoder is not yet feasible.
The present invention aims to offer a wavelet-inverse transformation technique and apparatus, as well as a wavelet-decoding method and apparatus. A bitstream encoded through a transformation of a normal whole image can be used to decode an optional partial image, without decoding the whole image.
In one aspect the present invention offers a wavelet inverse transform device including extraction of object coefficients by decoding to extract only coefficients that are necessary for decoding a specified area from wavelet transform coefficients,and waveslet inverse transform methods for inverse transformation of coefficients derived from the decoding object coefficient extracting means, wherein the decoding object’s coefficient extracting method extracts transform coefficients not only inside thespecified area but also outside of the defined area.
In another aspect, the present invention provides a wavelet inverse transform method including a decoding object coefficient extracting step of extracting only coefficients necessary for decoding a specified area from wavelet transformcoefficients, and a wavelet inverse transform step of inverse transforming coefficients extracted from the decoding object coefficient extracting means, wherein the decoding object coefficient extracting step extracts transform coefficients not onlyinside the specified area but also those outside the specified area.
In a different way, the present invention provides a decoding device including entropy decoding means for entropy decoding a bitstream encoded with entropy created by inverse wavelet transforms a photograph, and decoding the object’s coefficient and to extract, from the wavelet transform coefficients that are obtained from the entropy decoding method that are required for decoding a specified region, and inverse transforming wavelet means to reverse transform the coefficients extracted by the decoding objectcoefficient extracting means, wherein the decoding object coefficient extracting method extracts transform coefficients, not only within the defined area but also those on an outer edge of the space.
Another element of the invention is a wavelet-decoding method that incorporates an entropy method of decoding an encoded bitstream. This is followed by the extraction of decoding object coefficients that extracts from the coefficients of the wavelet transformation the necessary to decode a specific zone.
In the decoding object coefficient extracting method or step, the wavelet transform coefficients that are required to decode are extracted based on the information about the area that is that is determined by the decoding object area determining means or stepdetermining the area of the decoding object. These transform coefficients are then transformed in an inverse manner using the wavelet step or wavelet inverse transform methods. The overlap holding process is employed to extract the transform coefficients from the wavelet inverse transformation means or step.
The decoding area determining technique or step determines the decoding region using an external input. Decoding object coefficient extraction method or step extracts the coefficients that are necessary to decode the region in question and transfer the extracted coefficients the wavelet inverse transform method orstep. The decoding object coefficient extraction means or step extracts the coefficients that are required for decoding the region to send the coefficients extracted to wavelet’s inverse transform or step. Wavelet inverse transform step or method performs convolution using filter coefficients that are pre-set to lengths of taps.
According to the invention, a bitstream encoded, generated on wavelet inverse transforms a typical image, is inputted to decode a partial picture, without decoding the entire image.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA can refer to software functions that include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)”, which is software that is integrated (embedded inside) medical device.
Section 201(h),?21 U.S.C. 321(h),(1) defines the term “medical device” as apparatus, device machines, device, instrument or implant in vitro-reagent, or any other similar or related articles, including a component, that is. . . (b) is designed for the diagnosis or treatment of illnesses or other conditions that affect animals or humans. (c) is designed to alter the structure or functions of animals or human bodies. So, to be considered a medical device and consequently subject to FDA regulation, your program must meet one of two requirements:
- It must be designed for use in the treatment or diagnosis of a patient; or
- It is to be designed to modify the structure or functions of the body.
Thus, if your software is specifically designed for healthcare professionals to treat and diagnose patients, or is used in hospitals to manage patient data The FDA would likely view such software as medical devices that are subject to review by the regulatory authorities.
Is Your Software a Medical Device?
According to FDA’s current approach to oversight that considers the capabilities of the software, rather than the device’s platform, FDA will apply its supervision only to devices for medical use that possess capabilities that could be a risk to patient safety. Some examples of Device Software and Mobile Medical Apps FDA is focusing on
- Software functions that aid patients with diagnosed mental disorders (e.g., depression, anxiety, post-traumatic stress disorder (PTSD) for instance.) by providing “Skill of the Day”, a behavioral technique or audio message that users can access when they are suffering from anxiety.
- Software functions that provide periodic education information, reminders or motivational guidance for smokers who are trying to quit, who are recovering from addiction and pregnant women;
- Software functions that make use of GPS location data to warn asthmatics of environmental conditions that could trigger asthma symptoms or warn an addict (substance addicts) in proximity to a specified, high-risk location;
- Software functions that make use of video and games in order to entice patients to perform their exercise routines at home;
- Software functions which allow users to select which medication or herb they would like to use at the same time. They also give information about interactions and give an overview of the kind of interaction reported.
- Software functions that make use of factors that affect the health of a patient, like age, gender and risk factors for behavioral health to offer specific screening for patients, counseling , and preventive advice from well-known, established experts;
- Software functions that make use of an inventory of the most common signs and symptoms to provide an overview of health conditions and advise on when to see an expert in health care;
- Software functions that help users to complete a questionnaire regarding symptoms and give a recommendation for the most suitable healthcare facility for their needs.
- Mobile applications are designed to enable users to initiate a pre-specified nurse call or emergency call using broadband or mobile phone technology.
- Mobile apps that allow patients or their caregivers to create and transmit an alert or general emergency notification to first responders;
- Software functions keep track of medications and provide user-configured reminders for improved compliance with medication;
- Software functions that offer patients a portal into their personal health records including access to information captured during a prior visit to a doctor or historical trending and comparison of vital sign (e.g. body temperature or blood pressure, heart rate or respiratory rate);
- Software functions that reveal trends in personal healthcare incidents (e.g. hospitalization rates or alert notification rate)
- Software functions let users either manually or electronically enter blood pressure data, to share it with e-mail or track it, and then trend it, then upload it into an electronic health record.
- Mobile apps that offer dental health reminders and tracking tools for users with gum disease.
- Mobile apps offer patients with prediabetes guidance or tools to help them establish better eating habits or increase physical exercise
- Mobile apps that show, at opportune times, images or other messages to a user of a substance who is looking to end their addiction;
- Software functions that report drug-drug interactions, as well as relevant safety data (side effects and drug interactions and active ingredient) as a report based on demographic data (age, gender), clinical data (current diagnosis) and current medications; and
- Software functions that permit surgeons to identify the most effective intraocular lens power for the patient, as well as the orientation of the implant. The information is based on surgeon’s inputs (e.g., expected surgically induced astigmatism and the length of the patient’s axial axis, preoperative cornea astigmatism, etc.).
- Mobile apps, usually software that transforms mobile platforms into medical devices that are regulated.
- Software that is connected to a mobile device with a sensor or lead that measures and displays the electrical signals produced by the heart (electrocardiograph, ECG).
- Software that connects a sensor to the mobile platform or other tools within the platform, to view or record the eye movements in order to detect balance disorders
- Software that gathers information about potential donors and sends it to a blood collection facility. This program is used to determine if a potential donor is eligible to collect blood or other components.
- Software that can be connected to an existing device to regulate its operation, function, or energy source.
- Software that changes the functions or settings of an infusion pump
- Software that controls the inflation or deflation of the blood pressure Cuff
- Software to calibrate hearing devices and assesses the sound intensity characteristics and electroacoustic frequencies of master hearing aids and hearing aids for 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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