medical imaging has become a major tool in clinical trials since it enables rapid diagnosis with visualization and quantitative assessment. a typical clinical trial goes through multiple phases and can take up to eight years. clinical endpoints or outcomes are used to determine whether the therapy is safe and effective. once a patient reaches the endpoint, he or she is generally excluded from further experimental interaction. trials that rely solely on clinical endpoints are very costly as they have long durations and tend to need large numbers of patients. in contrast to clinical endpoints, surrogate endpoints have been shown to cut down the time required to confirm whether a drug has clinical benefits. imaging biomarkers (a characteristic that is objectively measured by an imaging technique, which is used as an indicator of pharmacological response to a therapy) and surrogate endpoints have shown to facilitate the use of small group sizes, obtaining quick results with good statistical power. imaging is able to reveal subtle change that is indicative of the progression of therapy that may be missed out by more subjective, traditional approaches. statistical bias is reduced as the findings are evaluated without any direct patient contact. imaging techniques such as positron emission tomography (pet) and magnetic resonance imaging (mri) are routinely used in oncology and neuroscience areas,. for example, measurement of tumour shrinkage is a commonly used surrogate endpoint in solid tumour response evaluation. this allows for faster and more objective assessment of the effects of anticancer drugs. in alzheimer's disease, mri scans of the entire brain can accurately assess the rate of hippocampal atrophy, while pet scans can measure the brain's metabolic activity by measuring regional glucose metabolism, and beta-amyloid plaques using tracers such as pittsburgh compound b (pib). historically less use has been made of quantitative medical imaging in other areas of drug development although interest is growing. an imaging-based trial will usually be made up of three components: a realistic imaging protocol. the protocol is an outline that standardizes (as far as practically possible) the way in which the images are acquired using the various modalities (pet, spect, ct, mri). it covers the specifics in which images are to be stored, processed and evaluated. an imaging centre that is responsible for collecting the images, perform quality control and provide tools for data storage, distribution and analysis. it is important for images acquired at different time points are displayed in a standardised format to maintain the reliability of the evaluation. certain specialised imaging contract research organizations provide end to end medical imaging services, from protocol design and site management through to data quality assurance and image analysis. clinical sites that recruit patients to generate the images to send back to the imaging centre. shielding lead is the main material used for radiographic shielding against scattered x-rays. in magnetic resonance imaging, there is mri rf shielding as well as magnetic shielding to prevent external disturbance of image quality. privacy protection medical imaging are generally covered by laws of medical privacy. for example, in the united states the health insurance portability and accountability act (hipaa) sets restrictions for health care providers on utilizing protected health information, which is any individually identifiable information relating to the past, present, or future physical or mental health of any individual. while there has not been any definitive legal decision in the matter, at least one study has indicated that medical imaging may contain biometric information that can uniquely identify a person, and so may qualify as phi. the uk general medical council's ethical guidelines indicate that the council does not require consent prior to secondary uses of x-ray images. industry organizations in the medical imaging industry include manufacturers of imaging equipment, freestanding radiology facilities, and hospitals. the global market for manufactured devices was estimated at $5 billion in 2018. notable manufacturers as of 2012 included fujifilm, ge, siemens healthineers, philips, shimadzu, toshiba, carestream health, hitachi, hologic, and esaote. in 2016, the manufacturing industry was characterized as oligopolistic and mature; new entrants included in samsung and neusoft medical. in the united states, as estimate as of 2015 places the us market for imaging scans at about $100b, with 60% occurring in hospitals and 40% occurring in freestanding clinics, such as the radnet chain. copyright united states as per chapter 300 of the compendium of u.s. copyright office practices, "the office will not register works produced by a machine or mere mechanical process that operates randomly or automatically without any creative input or intervention from a human author" including "medical imaging produced by x-rays, ultrasounds, magnetic resonance imaging, or other diagnostic equipment." this position differs from the broad copyright protections afforded to photographs. while the copyright compendium is an agency statutory interpretation and not legally binding, courts are likely to give deference to it if they find it reasonable. yet, there is no u.s. federal case law directly addressing the issue of the copyrightability of x-ray images. derivatives in a derivative of a medical image created in the u.s., added annotations and explanations may be copyrightable, but the medical image itself remains public domain. an extensive definition of the term derivative work is given by the united states copyright act in 17 u.s.c. § 101: a "derivative work" is a work based upon one or more preexisting works, such as a translation... art reproduction, abridgment, condensation, or any other form in which a work may be recast, transformed, or adapted. a work consisting of editorial revisions, annotations, elaborations, or other modifications which, as a whole, represent an original work of authorship, is a "derivative work". 17 u.s.c. § 103(b) provides: the copyright in a compilation or derivative work extends only to the material contributed by the author of such work, as distinguished from the preexisting material employed in the work, and does not imply any exclusive right in the preexisting material. the copyright in such work is independent of, and does not affect or enlarge the scope, duration, ownership, or subsistence of, any copyright protection in the preexisting material. germany in germany, x-ray images as well as mri, medical ultrasound, pet and scintigraphy images are protected by (copyright-like) related rights or neighbouring rights. this protection does not require creativity (as would be necessary for regular copyright protection) and lasts only for 50 years after image creation, if not published within 50 years, or for 50 years after the first legitimate publication. the letter of the law grants this right to the "lichtbildner", i.e. the person who created the image. the literature seems to uniformly consider the medical doctor, dentist or veterinary physician as the rights holder, which may result from the circumstance that in germany many x-rays are performed in ambulatory settings. united kingdom medical images created in the united kingdom will normally be protected by copyright due to "the high level of skill, labour and judgement required to produce a good quality x-ray, particularly to show contrast between bones and various soft tissues". the society of radiographers believe this copyright is owned by employer (unless the radiographer is self-employed—though even then their contract might require them to transfer ownership to the hospital). this copyright owner can grant certain permissions to whoever they wish, without giving up their ownership of the copyright. so the hospital and its employees will be given permission to use such radiographic images for the various purposes that they require for medical care. physicians employed at the hospital will, in their contracts, be given the right to publish patient information in journal papers or books they write (providing they are made anonymous). patients may also be granted permission to "do what they like with" their own images. sweden the cyber law in sweden states: "pictures can be protected as photographic works or as photographic pictures. the former requires a higher level of originality; the latter protects all types of photographs, also the ones taken by amateurs, or within medicine or science. the protection requires some sort of photographic technique being used, which includes digital cameras as well as holograms created by laser technique. the difference between the two types of work is the term of protection, which amounts to seventy years after the death of the author of a photographic work as opposed to fifty years, from the year in which the photographic picture was taken." medical imaging may possibly be included in the scope of "photography", similarly to a u.s. statement that "mri images, ct scans, and the like are analogous to photography."