The Future of Medical Records – FHIR

As medical care becomes increasingly sophisticated, the successful transfer and utilization of patient records is critical for providing the best outcomes. The Fast Healthcare Interoperability Resource (FHIR), developed by the nonprofit group Health Level 7 International (HL7), is the latest standard for such data. FHIR seeks to transform the way patient data is used by giving everyone from doctors to developers the opportunity to view and build on it in unprecedented ways.

Before FHIR, standards for sharing patient data could roughly be compared to PDFs. Health care providers receiving a report from another doctor could see the doctor’s notation, but generally not the underlying data that the doctor collected. Even if the provider was able to get access to that data, no protocol existed for filtering it or interacting with it. This informational gap severely hampered the ability of health care providers to collaborate in providing treatment.

FHIR, which was first released in 2011, uphanded this dynamic. Rather than providing static printouts, FHIR relies on data elements called “resources,” which are unique identifiers for medical information. Through combinations of these resources, FHIR expresses medical data, allowing health care providers to see and interact with the information. FHIR can be roughly compared to a URL, generating a dynamic form of patient records more akin to a webpage than a PDF.

The interoperability of FHIR leaves open many possibilities for future uses. The rise of wearable devices and Internet of Things technology means that there is more medical data floating around than ever before. Using FHIR, developers can create tools that allow health care providers and patients to utilize this data in innovative ways. For example, using the iOS app Apple Health, patients can now download their FHIR records. The app can keep those records up-to-date and organizes and presents them in a more user-friendly way, simplifying a previously confusing process. The resource-based nature of FHIR allows these records to be automatically updated every time new information is added. These discrete resources are then compiled for patient viewing on the Apple Health app, generating a readable report.

Doctors can also use Apple Health to view data from wearable devices such as the Apple Watch. With patient consent, doctors can incorporate heart rate data from such devices into medical records to help detect heart conditions and tailor treatment. In addition to Apple, Google, Microsoft, and Amazon are also working on applications that incorporate FHIR. FHIR apps are available on two primary marketplaces, run by software companies EPIC Systems and Cerner. Analogous to the iOS App Store or Google Play Store for smartphones, these two marketplaces allow developers to sell FHIR applications directly to consumers and healthcare professionals.

Doctors are also seeing other benefits from the integration that FHIR provides. A prime example is in the notation and documentation of medical records, which previously was a cumbersome process involving the use of dictation devices and apps to upload records to desktop-based records systems. Now, FHIR-based apps are beginning to emerge that can upload medical records quickly and seamlessly. The Nuance Surgical CAPD allows surgeons to create fully operative notes in less than 90 seconds. Doctors can dictate notes and capture images directly from their smartphones and upload them securely to a patient’s medical records.

One primary concern of FHIR developers is protecting patient privacy. While the open-source nature of FHIR allows increased collaboration and interoperability, it leaves open the possibility that third-party apps may not adequately protect sensitive medical data. In December 2018, EPIC instituted a three-month halt on applications by new developers to its FHIR “App Orchard.” EPIC later reopened enrollments with more stringent requirements for HIPAA compliance and security. With these concerns in mind, universities and medical providers have begun to give seals of approval to select FHIR applications that protect privacy. For example, Emory’s FHIR Advisory Committee gives formalized endorsements to apps that meet several criteria, one of which is protecting patient privacy.

Everyone who examines medical records, from hospital systems, to individual doctors, to insurance companies, will find FHIR helpful in creating a seamless patient experience and improving standards of care. FHIR apps are already serving innovate roles, from helping doctors manage medication dosage to streamlining directives for end of life care. FHIR will serve as a key building block of the medical records market for years to come, as the basis for innovative methods of sharing and analyzing medical data.

Clinical Trials 101

Any time a new drug appears on the market, the final product is a result of years of research and testing. The time from conception to FDA approval for medications takes 12 years on average. An important and time-consuming aspect of this process are clinical trials. By testing a drug on gradually increasing numbers of patients and volunteers, researchers are able verify that it is both safe and effective in treating the disease or condition. Only when the first three steps of this process are complete can the drug be approved and commercially distributed.

Phase 1 is the shortest of the three phases and involves the smallest sample size. This phase is the first time a new drug is tested on humans and establishes the product’s safety. During Phase 1, the drug is given to 20 to 50 volunteers. Generally, this process takes several months. By examining subjects over this period, researchers are able to determine the appropriate dosage, observe side effects, and glean limited information about the drug’s effectiveness. These data are taken into consideration as researchers plan for Phase 2, which approximately 70% of drugs move onto.

Phase 2 gives researchers a clearer picture of a drug’s efficacy and safety. With preliminary safety data available, testing can be expanded to groups of up to several hundred patients. While these samples typically aren’t large enough to fully test a drug’s effectiveness, the results provide further insight into whether it is safe. Phase 2 trials last several months to two years. They are critical in winnowing out unsafe or unsuccessful drugs, with only approximately 33% of drugs proceeding to Phase 3.

The longest and most complex step of clinical trials is Phase 3, which involves 30 to 300 patients and takes 1 to 4 years. Phase 3 answers the most critical question for any drug: whether it provides the beneficial treatment it was designed to. Researchers test this by randomizing the study’s participants. Half of patients receive the experimental drug, while the other half are given a placebo. Studies are usually double-blind, which means neither the participant nor the researchers know who is in which group. Results from the two groups are then compared to determine the effectiveness of the drug. Phase 3 also provides additional safety data by sometimes revealing side effects that went undetected in smaller sample groups. Approximately 25 to 30% of drugs complete this phase and are ready for FDA approval.

Once drugs are FDA approved and commercially available, further testing continues in Phase 4 clinical trials. Although the drug has already been approved, Phase 4 allows for analysis of any long-term effects. Additionally, Phase 4 allows for more organic testing among groups that may not have been studied due to the controlled nature of previous phases, such as those simultaneously taking other drugs. Sometimes, drugs are banned from use by the FDA after harmful side effects emerge during Phase 4.

Clinical trials are a time-consuming, expensive, and selective process. Drugs that make it through and are FDA approved have an average cost of $41,117 per patient just for clinical trials. The federal government has created a database that is home to information about both privately and publicly funded clinical studies around the world. However, clinical trials remain the most comprehensive method available to ensure that every drug marketed in the U.S. is both safe and effective. Doctors and patients can have confidence knowing the drugs they prescribe, and use, have been put to this test and passed.

drug discovery timeline graphic

Medical Device Approvals 101

Countless patients, clinicians, and caregivers have relied on medical devices over the years for health needs. But bringing a medical device to market in the United States is no easy task. It involves not just building the device and testing it, but also obtaining regulatory approval from the Food and Drug Administration (FDA) prior to marketing the device. What follows is a simplified overview of the regulatory process.

Medical devices are broadly grouped into three classes based on the potential risk and intended use: Class I, II, and III. Class I is the lowest risk and includes things people may not often think of as medical devices like tongue depressors and latex gloves. 47% of all devices fall into Class I. Class II devices (43% of all devices) include infusion pumps, surgical needles, and powered wheelchairs. Class III devices carry the most risk and are the least prevalent class of all devices (10%). The FDA defines these devices as “those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” Examples include implantable pacemakers and replacement heart valves. Devices in each of these classes may be subject to one of several pre-submission FDA regulatory pathways. Two of the most common are 510(k) and PMA.

510(k), otherwise known as pre-market notification or PMN, is the simpler and less costly route, and it is for lower risk devices. The name comes from it being in Section 510, paragraph “k” of the Federal Food, Drug, and Cosmetics Act. All Class I, II, and III devices that do not require PMA must have a 510(k) submission, unless they are subject to exemption. Most Class I devices and some Class II devices are exempt from 510(k) requirements. 510(k) notification involves identification of a legally marketed “predicate device” that is substantially equivalent to your device. Once substantial equivalence has been shown and confirmed by the FDA, the device can be marketed in the US. The time from 510(k) submission to when you hear back from the FDA is typically 90 days or less.

PMA, short for pre-market approval, is required for all Class III medical devices (unless they were on the market prior to 1976, when the FDA started regulating medical devices). It is a substantially more involved process (time and money), in some ways similar to the clinical trials process mandated for new drugs to go to market. PMA requires demonstrating the device is safe and effective for its intended use, not just that it is substantially equivalent to an existing device. The application packet requires extensive laboratory and clinical studies. Beyond the cost of developing the device, one must also factor in the cost of FDA submission. As of the time this blog was written, the standard fee for submitting a PMA application is $322,147 ($80,537 for a small business), versus $10,953 ($2,738 for a small business).

If you are trying to determine which category your device falls under, you should start by checking out the FDA’s guidelines for determining that on their website here

What is HIPAA?

Losing your job is hard enough. But what if you lost your healthcare insurance along with it? And there were no standardized ways to keep or transfer your health information? Although this scenario may seem hard to fathom today, in the not-so-distant past the loss of employer-based health insurance and irregular recordkeeping were very real fears. The Health Insurance Portability and Accountability Act (HIPAA) was passed in 1996 to address many concerns around health records and coverage. There are five sections (“titles”) to the act:

Title I: HIPAA Health Insurance Reform | Health care access, portability and renewability

Title I was implemented to address the availability of health insurance for individuals. In other words, it protects patients who might otherwise not have access to health insurance. It requires that during a change or loss of job, the employee may still have access to his insurance plan.

Title II: HIPAA Administrative Simplification| Preventing health care fraud and abuse; administrative simplification; medical liability reform

Title II requires the Department of Health and Human Services (HHS) to develop standards for the use and dissemination of healthcare information, a stipulation that resulted in the creation of the Privacy Rule and Security Rule. Both are intended to prevent health care fraud and abuse. The Privacy Rule establishes national standards for the protection of certain health information known as Protected Health Information (PHI). The Security Rule establishes a national set of security standards for ePHI, protected information that is stored or transferred electronically.

Title III: HIPAA Tax-Related Health Provisions

This title adjusts laws regarding health insurance and medical deductions. The most important example of this might be the standardization of the amount that may be saved per person in a pre-tax medical savings account (MSA). Since 1997, MSAs have been available to employees covered under an employer-sponsored high deductible plan of a small employer and self-employed individuals.

Title IV: Application and Enforcement of Group Health Plan Requirements

Title IV specifies that employees cannot be denied coverage due to preexisting conditions or medical history.

Title V: Revenue Offsets

This title makes special provisions regarding company-owned life insurance, treatment of expatriated individuals, and also repeals the IRC’s financial institution rule to interest allocation rules.

HIPAA affects all organizations that directly maintain and transmit protected health information. These include hospitals, healthcare providers, laboratories, health insurance companies, pharmacies and more. The Privacy and Security Rules have impacted the way these organizations operate and changed the landscape of healthcare treatment.

Some critics argue that HIPAA has built roadblocks that impede healthcare research, as healthcare organizations cannot perform studies based on patient chart data without consent. They claim that this has driven up costs of recruitment for studies and surveys.

Critics also point out that since patient data cannot be shared between healthcare providers without patient permission, some records are not transferred in a timely manner. Many people point to the complexity of implementing HIPAA as cause for increased expenses for healthcare providers.

On the other hand, many say HIPAA has bolstered information security in those same organizations. Standards for patient confidentiality and healthcare information have been established across organizations and information transfer is more secure and efficient. As a result of HIPAA, patients and their information are more protected than ever before.

HIPAA has become an ingrained part of the US healthcare system, impacting the millions who depend on hospitals, physicians, and other providers for life-saving treatments. Understanding HIPAA is key to understanding healthcare in America.

Resources:
https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html
https://en.wikipedia.org/wiki/Health_Insurance_Portability_and_Accountability_Act

Antibodies as Biomarkers in the Detection of Cancer

The early detection of cancer is vital for successful treatment as well as increasing survival rates, and the ability to come up with a reliable way to determine cancer phenotypes early could potentially save many lives. Identification of new serum antibodies as biomarkers in cancer phenotypes could prove to be an effective and precise method of detecting cancer. Tumors, specifically, tend to release into the circulatory system proteins, hormones, and other markers that can be detected in serum blood.

Despite this knowledge, there are few genomic and proteomic methods that have produced a standardized and noninvasive method of cancer screening and early detection. A vast majority of proteins released by tumor tend to be in low, if not undetectable, quantities, and have a rapid clearance rate due to the rapid metabolic rate of cancer cells.

Due to this inability to accurately quantify the secretions of cancer tumors, many scientists have turned to autoantibodies – antibodies produced by the patient’s own immune system. These antibodies have shown promise in becoming a biomarker for the detection of cancer phenotypes. Autoantibodies are produced in large quantities despite the corresponding low concentrations of antigens found among cancer cells.

New methods have emerged for the discovery of new autoantibody targets; these new methods include phage-splay libraries, recombinant cDNA expression cloning, and self-assembling protein arrays. The specificity of these targets have proved to be an issue in these novel methods because scientists must avoid targets identified by antibodies present in patients that do not have cancer or have benign tumors. These methods are being refined to improve their sensitivity and specificity.

Exploring alternative, novel biomarkers for diagnostic potential is a rapidly growing field, and one that Emory researchers have not shied away from. Emory University has pioneered several biomarker assays to predict cancer phenotypes. Many of these cancers are known to be more chemotherapy-resistant than others, and this resistance is attributable to the expression of certain genes in cancer cells. Emory University researchers identified the expression of certain genes in small cell lung cancer. By assaying the expression of these genes in tumors, cancers can be identified quickly and more targeted, individualized therapies can be developed.

Emory researchers have identified RNA biomarkers to detect prostate cancers that could not only screen, but accurately predict recurrence of certain prostate cancers reliably. Researchers have also identified DNA biomarkers in the form of cell-free DNA to accurately identify and diagnose renal cell carcinomas.

Although Emory has not yet delved into the biomarker potential of antibodies, researchers have identified antibodies in the treatment of certain cancers, such as myelomas (Elotuzumab) and mesotheliomas (Durvalumab). At the forefront of biomedical research and discovery, it will not be long before Emory further explores the multipurpose of antibodies in the rapidly growing field of oncology.

Johannes W. Pedersen, Hans H. Wandall; Autoantibodies as Biomarkers in Cancer, Laboratory Medicine, Volume 42, Issue 10, 1 October 2011, Pages 623–628, https://doi.org/10.1309/LM2T3OU3RZRTHKSN

The Promise of Biomarkers and Antibodies

Biomarkers, an abbreviation of “biological markers,” serve as medical indicators for the disease state observed from outside the patient. This measure is both precise and replicable, and accounts for a chemical, physical, or biological response. [1]

Biomarkers have been around for quite some time, and we see examples of them in our everyday lives. Blood pressure, for example, can serve as a biomarker for the physiological state of a patient or a patient population. Similarly, body temperature, or presence of a fever, can indicate to us a change in a person’s state of being, from diseased to healthy or vice versa.

Biomarkers are often used as clinical endpoints while measuring biological processes, especially as a function of disease. Biomarkers are often surrogate endpoints in clinical trials; that is, they serve as substitutes when a clinically relevant endpoint cannot be identified. The advantage to this is that many clinical endpoints, such as survival (a measure of death), are not reliable predictors due to infrequency of occurrence or unethical practices, such as manipulating the survival of individuals. By using a biomarker, researchers can reduce harm and risk to a subject while still producing clinically relevant conclusions. [1]

Biomarkers play a large role in the drug development process; they bridge the gap between the measurable biological outcomes and clinical outcomes. However, biomarkers are limited in how well they can reproduce physiological consequences of disease.[1]

On the other hand, antibodies are abundant, stable-in-serum biomarkers that can predict a variety of pathologies. Many comparable biomarkers have a tendency to run dilute, and detection can prove difficult, particularly over extended periods of time. [2]

Natural antibodies are the body’s biomarkers, and help the immune system monitor the body. Antibodies in the body can serve as biomarkers that indicate the functional changes of the body system that they are functioning in. [3] Antibodies are the body’s way of detecting a change in the expression of a protein, which in turn can indicate the progression of a disease or infection. Harnessing the natural properties of antibodies as biomarkers, or clinical indicators, could prove to be successful on a larger scale in the future. The ability for antibodies to remain stable in blood serum over extended periods of time could change the way clinical trials are conducted.

[1] Strimbu, K., & Tavel, J. A. (2010). What are Biomarkers? Current Opinion in HIV and AIDS 5(6), 463–466. http://doi.org/10.1097/COH.0b013e32833ed177

[2] Sabatino, A. D., Biagi, F., Lenzi, M., Frulloni, L., Lenti, M. V., Giuffrida, P., & Corazza, G. R. (2017). Clinical usefulness of serum antibodies as biomarkers of gastrointestinal and liver diseases. Digestive and Liver Disease,49(9), 947-956. doi:10.1016/j.dld.2017.06.010

[3] Xu, X., Ng, S. M., Hassouna, E., Warrington, A., Oh, S. H., & Rodriguez, M. (2015). Human-derived natural antibodies: biomarkers and potential therapeutics. Future Neurol, 10(1), 25-39. doi:10.2217/fnl.14.62

The Benefit of Master Agreements

Master agreements help set standard terms between two parties of a contractual, reciprocal agreement. The process of two parties having to repeatedly enter into a separate agreement of the same type can be tedious, time consuming and potentially detrimental to a business relationship, especially if the parties find themselves constantly revising and renegotiating agreement terms. Doing so can significantly slow down the time it takes to initiate sponsored research projects or productization of licensed inventions.

The master agreement specifically covers standard terms that apply to a particular type of transaction between two parties. These agreements set out the basic framework of the working relationship between the two parties. Emory University, specifically, negotiates master agreements that cover the terms of clinical trials, sponsored research, research tools, and confidentiality. By agreeing to standard terms upfront, the parties save a significant amount of time when a new project or engagement is initiated. With the umbrella agreement in place, a relatively short addendum, work order, or similar is executed for a specific item/project. There are some terms that need to be agreed upon for each project under a master agreement such as project scope of work, finances, and IP rights.

Master agreements themselves can cover a broad spectrum of terms; for example, indemnification, which is a part of an agreement that stipulates that one party in the agreement will absorb monetary costs for losses that a second party may incur. Other terms can be items such as termination, confidentiality, data ownership, publication and reporting.

Creating a large, comprehensive agreement is not without its pitfalls. Parties involved must be incredibly thorough and make sure that they can live with the terms, as once a master agreement has been signed off on, making changes can be difficult.

Master agreements are generally a benefit to both parties. Investigators are extremely supportive of master agreements, given they can significantly shorten the waiting time before a research project can begin. The university and company save on personnel time and resources by engaging in one extensive negotiation rather than multiple negotiations, which is a much more inefficient process. Putting several agreements under one master agreement saves time and effort while simultaneously establishing a working business relationship. Streamlining the process makes companies and institutions more willing to work with one another.

While the investment it takes to negotiate the initial agreement can be significant, once the master agreement is in place, individual agreements covering a research study or commercial license can be finalized within a matter of a few days. The time it takes to develop the initial master agreement can vary greatly and depends on the level of priority a company assigns to such an agreement, but one thing remains for sure: master agreements are almost universally appreciated and preferred in the industry.

What are Orphan and Rare Diseases?

Rare diseases affect very small populations of individuals. According to the United States Food and Drug Administration (FDA), orphan diseases are those that specifically affect less than 200,000 people within the nation; many of these rare diseases are also genetic. Some of these rare diseases include cystic fibrosis, Huntingon’s disease, Aarskog syndrome, Waardenburg syndrome, and Fabry disease.

During the summer of 2014, more than one hundred million dollars were raised in the fight against a rare disease called amyotrophic lateral sclerosis—or ALS—through a movement called the ALS Ice Bucket Challenge. Participants would dump a bucket of ice water over their friends’ heads, capture the moment on video, educate viewers about ALS, and even urge others to participate in the challenge or donate to the cause. ALS, also commonly referred to as Lou Gehrig’s disease, is a neurodegenerative disease characterized by an eventual loss of muscle control and movement; an estimated 20,000 Americans have ALS at a given time.

According to the Genetic and Rare Diseases (GARD) Information Center in the National Institutes of Health (NIH), approximately twenty-five to thirty million Americans live with rare diseases; they further estimate that there may be up to 7,000 rare diseases in existence. Therefore, while rare diseases individually affect a small portion of the population, all rare diseases cumulatively impact a significant number of Americans.

However, since each rare disease individually affects very few individuals, companies initially had very little incentive to develop drugs to treat these diseases; such drugs would not necessarily provide profits with such small patient populations. In fact, according to GARD, rare diseases were coined “orphan” diseases because drug companies did not want to “adopt” them and provide treatments for them.

In 1983, Congress passed the Orphan Drug Act (ODA) to create financial incentives to facilitate necessary orphan drug development. Some of these incentives included tax credits for research, grant funding, and marketing opportunities. For example, grants such as the Orphan Products Clinical Trials Grants Program help provide funding towards clinical research “that tests the safety and efficacy of drugs, biologics, medical devices, and medical foods in rare diseases or conditions.” The FDA even currently has an entire office dedicated to overseeing products related to rare diseases; the mission of the FDA’s Office of Orphan Products Development is to “advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.”

According to the FDA, in the decade preceding the ODA, less than ten treatments for orphan diseases were approved; in the years since it passed, however, hundreds of orphan drugs have since been developed. Approved orphan drugs to treat ALS, for instance, include Edaravone and Riluzole. While research into treatments for orphan and rare diseases is ongoing, the advancements performed over the years are encouraging for future progress.

Orphan Drugs & Priority Review Vouchers

Rare illnesses and medical problems are often neglected in the pharmaceutical industry. This is because drug developers opt to focus on illnesses that are prevalent and their treatments more lucrative. The Federal Drug Administration (FDA) is addressing this problem with Priority Voucher Review Programs, whose recipients are awarded expedited FDA review for their future product. These vouchers have specific requirements in place making them applicable only to drugs being developed for overlooked afflictions, also known as “orphan drugs.” The main drug ingredient must not yet be approved by the FDA, which supports innovation while potentially decreasing overuse of antibiotics and subsequent resistance. Voucher programs are in place for treatments or preventatives in three areas: rare pediatric diseases, rare tropical diseases, and medical countermeasures for possible terroristic threats. Tropical diseases include Zika, malaria, filovirus, cholera, and leprosy and more; the list of accepted ailments is open to being added to. Medical countermeasures include treatments and preventatives for nuclear, chemical, biological, and radiological threats that the Department of Homeland Security finds significant.

These vouchers are attractive to drug developers for a variety of reasons. The development process often takes many years from conception to market placement, so early approval can provide a significant advantage over competitors, and shorter review time means money can be saved and directed toward other priorities. These vouchers are also able to be sold or traded to other companies, heightening their general value. These benefits are intended to be incentives to encourage companies to develop drugs in these underserved areas.

The program began a little more than 10 years ago, in September of 2007. The concept was designed by economic professors at Duke University and was intended to help with the long- standing problem of recognizing medical needs in developing countries. The first PRV was awarded to the antimalarial drug Coartem®, developed by Novartis Pharmaceuticals. Coartem was already a successful and popular drug in other countries, making it an easy first choice for expedited U.S. FDA review and approval. Since then, 14 vouchers have been awarded: six of which have been used for rare pediatric diseases, five for tropical diseases. Many vouchers remain unused, however, with companies waiting to put them toward a promising drug innovation or a lucrative trade.

There are specific conditions to the use of these vouchers. The voucher only benefits review time, not the approval itself, and the FDA has set a user fee that ranges from 2 million to 5 million dollars. This could be a worthless investment if the drug fails, so companies must be sure of their product’s effectiveness if they are to use a voucher. In addition, excluding pediatric priority review, vouchers can only be traded once.

These vouchers exist as a counterbalance to market forces. As with anything within the economic field, supply is consistent with demand. This works in most cases; however, sometimes this causes serious problems to be overlooked due to relative lack of profitability. Tools like that of Priority Review Vouchers aim to discourage stagnation of drug exploration in underserved areas and support finding life-saving or life-improving treatments for those in need.

The Ins and Outs of Creative Commons Manuscript Submissions

It’s fairly easy to prove ownership of a newly-purchased jacket: simply pull out your receipt. But what about a story you wrote, or an invention you designed? What if someone takes your original plan and modifies it? What if a rival claims you stole their idea?

The question of ownership only amplifies in importance as technology and progress gains more speed than ever before. In the field of research, this question is critical: what is the point in investing in and developing a technology that the competition can copy as soon as you share it?

Copyrights, trademarks, patents, and licenses help to regulate this increasingly-sticky area. While the first three of these methods are designed to protect intellectual property, a license sets the terms of how that property can be used by others. The Creative Commons license is one such tool, and has helped protect over 1.1 billion works to date. Creative Commons is a nonprofit organization that provides platforms in which creators can license and share their work. Having this form of protection allows scientists to claim their authorship, and is often a requirement for submission to scientific journals hoping for the publishers to avoid legal troubles. These licenses “facilitate the dissemination of knowledge while maintaining control of intellectual property,” according to Hyeon (Sean) Kim, MS, MBA, a Licensing Associate at Emory University. By reducing the risk of plagiarism and data-theft, scientific findings can be more freely shared discussed, producing a wider breadth of scholarship available to the public without compromising the rights of the creators.

Creative Commons is affiliated with sharing platforms such as flickr, Wikipedia, and Youtube in order to make works more accessible online. Meanwhile, Creative Commons provides licensing that affirms the creator’s ownership and intellectual property right such ascopyright. Kim explained that “the Creative Commons license is a backbone” that protects the ownership and integrity of the work. In addition to the core protection provided by the license, the owner must choose one of six possible attributes. Attributes “further expand restrictions or permissions,” such as whether or not the work can be used for commercial use or whether it can be modified. Commercial use is defined as any activity that results in profit. If a work is used non-commercially, it still requires a citation. By choosing a more conservative attribution, Kim said, any patent applications filed for or issued patent directed to the work can still be licensed for commercial use and receive royalty payments down the road.

Creative Commons is rapidly growing, and it’s easy to see why: it gives authors the ability to license (and later publish) their work through an affordable and user-friendly interface. According to Kim, submitting to Creative Commons is as easy as “uploading a picture to Facebook. Since everything is processed online, owners don’t have to write complex license agreement on their own. “The caveat is that they have to be really careful,” said Kim, as it is up to the owner to choose the licensing agreement that is best for him or her. While Creative Commons provides a Commons Deed which explains each license in laymen’s terms, it is not always easy for the owner to distinguish which version best fits his or her legal needs. Kim’s job is to help Emory scientists navigate this sometimes-confusing process.

The protections of Creative Commons and other licenses have fostered a scientific environment of creation and exploration. Assured that their work cannot be stolen or modified without their permission, researchers are able to publish and share their manuscripts easier than ever before. The increased communication between scientists and the public has helped to encourage the explosion of research and technology in the United States and around the world. As innovation and demand for copyright licensing grows, the role of Creative Commons will only become more prominent in today’s globalized world.