Sony Corporation (Tokyo, JP)
What is a Software Medical Device for Wavelet inverse transform method , device and method for decoding wavelets and apparatus
Is Your Software a Medical Device for Wavelet inverse transform method , device and method for decoding wavelets and apparatus
1. Field of the Invention
This invention relates to a wavelet-inverse transform technique and apparatus for the extraction and decoding of only the transform coefficients of an identified partial area from wavelet transform coefficients obtained on the encoding process using the wavelet transform.This invention is also related to a similar wavelet decoding method and apparatus.
2. Description of related art
The ISO (International Organization for Standardization) has standardized the JPEG system (Joint Photographic Experts Group), which is an alternative to traditional image 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. However, if the number of bits used to encode is reduced to a greater degree, the distortion of blocks due to DCT can be seen as outstanding, so that subjective deterioration becomes apparent. On the other hand, this kind of system where an entire picture is split into multiple bands using a filter, termed a filter bank, comprising the combination of a high-pass filter and an low-pass filter, and encoding is performed from one band to another and is currently being investigated quickly. Particularly the wavelet encoder that is free from the defect of block distortion, that shines in high compression such as in DCT, is thought to be a promising method that could take the place of the DCT.
Nowadays, an electronic camera, or video movie utilizes JPEG or MPEG, with the transform system being DCT. Since a product based on the wavelet transform is expected to be introduced for sale in the the months to come, studies to improve the efficiency of the encoding system are moving quickly in a variety of research institutes. As a matter of fact, JPEG 2000, now being worked by ISO/IEC/JTC1_SC29/WG1, which is the same organization as the JPEG, as a format the recommendationfor the standardization of which is scheduled to be issued in December 2000, is felt to be promising as the next-generation international standardization system for still pictures. With this JPEG 2000 is almost been established to use the wavelettransform to replace the preexisting DCT in JPEG as a primary transformation system for picture compression.
The invention solves the issue of expanding only a portion of wavelet inverse transform. That is, the entire wavelet transform coefficients are not read out and decoded, as is done in the conventionaltechnique. This is an advantage in terms of reducing memory capacity. In the process of encoding wavelets, wavelet transform needs to be applied to the entire image to store and hold the coefficients of the wavelet transformation temporarily in memory. Wavelet decoding is the opposite of wavelet decoding and requires a large memory capacity to store and store the coefficients for the entire image. The memory capacity must be increased if the imagesize is increased. Thus, the conventional practice is not desirable on a device with a limited memory capacity, like an electronic still camera, camcorder or PDA.
Recent research has shown that this technique could be used to encode an entire object in a block-based manner. This can be done as an example in the international standardization activities of JPEG 2000. If the encoder is performed using block-based bases from the outset partial decoding is achieved by reading out an encoded bitstream associated with a pre-set block. However, there lacks up yet a study into partial decoding in the absence ofconstraint on the encoder.
The present invention is designed to provide a wavelet inverse transform technique and apparatus, and a wavelet-decoding method and apparatus. A bitstream encoded through a wavelet transform of an whole image can be used to decode a partial image, without decoding the whole picture.
In one aspect the invention is a an inverse transformation device using wavelets, comprising decoding object coefficient extracting means to extract only the coefficients required to decode a specific region from the wavelet transform coefficients, and waveslet inverse transform methods to inverse transform the coefficients extracted from the decoding object coefficient extracting methods, wherein the decoding object coefficient extraction means extracts transform coefficients not just within the specified area, as well as those that are outside the area of the specified.
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 offers a decoding device including the entropy decoding method for decoding a bitstream encoded, generated on wavelet inverse transforms a photograph, decoding object coefficient extracting means to extract, from the wavelet transform coefficients extracted by the entropy decoding means, those necessary to decode a specific area , and also wavelet inverse transformation means to reverse transform the coefficients obtained by the decoding objectcoefficient extracting method, in which the decoding object’s coefficient extracting method extracts transform coefficients that are not only in the specified area but also in the outside rim of the region.
In another aspect, the present invention provides a wavelet decoding method including an entropy decoding step of entropy decoding an encoded bitstream, generated on wavelet inverse transforming a picture, a decoding object coefficientextracting step of extracting, from among wavelet transform coefficients obtained by the entropy decoding step, those necessary for decoding a specified area and a wavelet inverse transforming step of inverse transforming the coefficients extracted bythe decoding object coefficient extracting step, wherein the decoding object coefficient extracting step extracts transform coefficients not only in the specified area but also those on an outer rim of the specified area.
The decoding object code extracting means or the step are able to extract the needed wavelet transform coefficients to decode from the information regarding an area which has been identified through the step or decoding area determining method. These transform coefficients then are reverse-transformed by using the step or wavelet inverse transform methods. The overlap holding process is used to extract the transform coefficients of the wavelet’s steps or inverse transformation methods.
The decoding area determining means or step is able to determine a decoding object area using an external input or determining methods or steps to transmit the coordinates of apices’ positions in case of a rectangular area and the information about the center’s position as and the radius in case of a circular region. Decoding object coefficient extraction method or step extracts the coefficients necessary for decoding the area in question to send the extracted coefficients to the wavelet inverse transform method or step. The decoding of object code extraction or process extracts the necessary coefficients to decode the area , and transmit them to the wavelet step, or the wavelet inverse transform. The wavelet’s inverse transform or step performsconvolution by filter coefficients having pre-set tap lengths and wavelet transform coefficients in order to create a decoded image of the specified area.
The present invention offers an encoded bitstream that is created by inverse wavelet transformation of a normal image. It is able to be used to decode an optional part of the image however, it is not the entire image.
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What is a software medical device?
The FDA refers to functions in software that can comprise ” Software as a Medical Device” (SaMD), and “Software in Medical Device (SiMD) ), which is software that is integral to (embedded in) an medical device.
Section 201(h) of the Federal Food, Drug, and Cosmetic Act, ?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, instrument machines, machines, contrivances, implant, in vitro regulator or other similar or related articles in addition to a component or accessory. . . (b) is intended to be used in the diagnosis of disease or other conditions, or in the treatment, mitigation, treatment, or prevention of diseases for humans or other animals, or (c) intended to affect the structure or function of the body of man or any other animal.? To be considered a medical device and consequently subject to FDA regulations, the software must meet at least one of these criteria:
- It should be used for diagnosing and treating patients.
- It is not intended to alter the structure or function of the body.
If your software is designed to be used by healthcare professionals to diagnose manage, or treat patient information in hospitals and other medical facilities, the FDA is likely to consider the software as medical devices and subject to regulatory review.
Is Your Software a Medical Device?
In accordance with FDA’s current oversight strategy which looks at the capabilities of the software higher than the platform, FDA will apply its regulation only to medical devices that have capabilities that could be a risk to the safety of patients. Some examples of Device Software and Mobile Medical Apps that FDA is focusing on include
- Software functions that aid those suffering from mental illness (e.g. depression, anxiety, post-traumatic stress disorder (PTSD) for instance.) through the use of “Skill of the Day” an approach to behavior or audio message that users can access when experiencing anxiety.
- Software functions provide periodic reminders, motivational support and information on education to those recovering from addiction or trying to quit;
- Software functions that utilize GPS location information to notify asthmatics of conditions in the environment that could trigger asthma symptoms, or to notify an addict (substance users) in proximity to a specified high-risk or high-risk location.
- Software that utilizes games and videos to motivate patients to take part in exercise at home.
- Software functions that prompt users to choose which herb or drug they wish to consume at the same time. They also provide information on interactions and provide a summary of the type of interaction reported.
- Software functions that make use of factors that affect the health of a patient, like age, sex and other risk factors for behavior to provide specific screenings for each patient and counseling, as well as preventive advice from well-known and reputable authorities;
- Software functions that use a list of typical signs and symptoms to provide the possibility of medical conditions , as well as advice on when it is appropriate to speak with a health care provider;
- Software functions that lead the user through a checklist of signs and symptoms to provide a recommendation for the type of healthcare facility that is best suited to their requirements;
- The mobile apps enable users to make nurse calls or emergency calls using the internet or cell phone technology.
- Apps that allow caregivers or patients to notify emergency situations to first responders through mobile phones
- Software that tracks medications and gives users user-defined reminders to 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 previous clinical visit or historical trends and comparative analysis of vital sign (e.g. body temperature or heart rate, blood pressure, or respiration rate);
- Software functions that aggregate and show patterns in health-related incidents that affect individuals (e.g., rate of hospitalization or alert notification);
- Software features let users either manually or electronically enter blood pressure data, to share it with e-mail, track it and trend it, and upload it into an electronic or personal health record.
- Mobile apps that allow for tracking and reminders about oral health. They also provide instruments to monitor patients who suffer from gum disease.
- Apps that offer mobile guidance and tools for prediabetes patients;
- Mobile apps that show at the right time, images or other messages for a substance abuser who wants to end their addiction;
- Software functions that offer drug-drug interactions and relevant safety data (side effects or drug interactions and active ingredient) in a report based on demographic information (age and gender), clinical information (current diagnosis) and current medications as well as
- Software functions provide the surgeon with an inventory of intraocular lens powers and recommended an axis for implantation based upon information provided by the surgeon (e.g., predicted surgically induced astigmatism the length of the patient’s axial axis and preoperative corneal astigmatism, etc.)
- Software, typically mobile apps that transforms mobile platforms into an approved medical device.
- Software that is connected to a mobile device by using 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, in order to monitor or record eye movements to diagnose balance disorders
- Software that questions potential donors about their history with donors and records and/or transmits those answers to a blood collection facility. This software is used to determine if a potential donor is eligible before collecting blood or any other component.
- Software that is connected to the device’s type in order to control its operation function, or energy source.
- Software that alters the functions or settings of an infusion pump.
- Software that regulates inflation or deflation of a blood pressure cuff
- Software is used to calibrate hearing aids and to evaluate the electroacoustic frequency, the characteristics of sound intensity, and sound quality of hearing aids master hearing aids hearing aids that are group-based, 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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