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

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

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

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.

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.

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.

Universities, hospitals, small businesses, and research centers have long been hotbeds of scientific innovation and discovery. However, in the past many of the scientific advances being made at these institutions failed to be developed into products and medicines that could benefit society. In large part, they remained ideas and visions because the existing policies and legislation did not incentivize researchers or their institutions to further develop and commercialize their work. This all changed in 1980 with the passage of the Bayh-Dole Act, which reimagined patent and copyright policies applied to federally funded research and facilitated the development of numerous products and medications.

The federal government has been a large, if not the largest funder, of basic research carried out in the United States since the end of World War II. This longstanding investment in scientific and technological research can arguably be traced back to the 1945 report by Vannevar Bush, then head of the U.S. Office of Scientific Research and Development, entitled “Science, The Endless Frontier.” In this report, Bush argued that “Scientific progress is one essential key to our security as a nation, to our better health, to more jobs, to a higher standard of living, and to our cultural progress.”

Bush’s argument encouraged President Harry S. Truman to boost government spending on research and development, increasing the research capacities of the nation’s labs and universities. However, despite significant in the amount of federal funds designated for scientific research, the full potential of these discoveries was not being reached. Innovations developed with federal funding were typically early stage developments and not fully formed marketable products. Nevertheless, the title (ownership) of any invention created from federally funded research were retained by the government; cutting-edge research being funded by American tax dollars was was languishing. In fact, in certain instances companies from other countries like Japan were taking research done by American scientists and funded by the American people and developing it into marketable products that were being sold back to American consumers.

The government’s legal ownership over any potential inventions created using federal grants complicated the public and private sector research efforts. Often researchers never fully developed their ideas into finalized, marketable products because they did not possess legal rights to the fruits of their research. Joe Allen, a former staffer for Senator Birch Bayh and champion of the Bayh-Dole Act, said “We basically had a segregated wall between the best and the brightest in our public and private sectors. It was a barrier for the private and public sectors doing joint research.” This barrier was evidenced by a study done in the 1970s that found that approximately 28,000 patents from federally funded research had been accumulated by the government, yet less than 5 percent of those innovations had been commercially developed and additionally, no drugs had been developed from drug related research. Allen and others, he worked with realized that they “must structure the incentives of the patent system so that when someone made an invention with government funding they had the incentive to develop it. If a researcher did not own their invention, they would not have the incentive to remain involved with it and it would never be commercialized.”

With the onset of the 1970’s economic recession the issues surrounding the potential missed opportunities of public benefit from federal research funding reached a critical new juncture. Allen reflects, “We could no longer afford to give away the fruits of billions and billions of hard earned tax payer research and get nothing out of it.” During this time Joe Allen, as a representative for Democratic Senator Birch Bayh of Indiana, began meeting with staff from Purdue University and the University of Wisconsin, who complained that the ownership of innovations created through federally funded research were not being retained by their institutions.

Birch Bayh, partnered with Republican Senator Bob Dole of Kansas to co-sponsor the Bayh-Dole Act or the Patent and Trademark Law Amendments Act. This act transferred the ownership of innovations created through federally funded research from the federal government to those universities, small business, and non-profits, thereby incentivizing them. The act stipulated that the federal government retain a non-exclusive license; that they must give a preference for United States based manufacturers and small businesses, thereby incentivizing the creation of American Jobs; that any royalties from the inventions must go back into education and research; and that the institutions reward the inventors, consequently increasing those individual’s stake in the product’s development. “Basically,” says Allen, “the main concept was to have the government fund the research and oversee a few basic rules, but then to get out of the way and not try to predict what was going to happen with any given invention.”

The Bayh-Dole Act was officially enacted in December 12, 1980 and has been largely seen as a success over the past few decades. Between 1996 and 2013 it added $1.18 trillion dollars to the economy, created over 3.8 million jobs[1] and an average 2.5 companies a day[2]. Furthermore, it currently accounts for almost a third of the value of NASDAQ[3]. The Economist Technology Quarterly said it is, “Probably the most inspired piece of legislation to be enacted in America over the past century[4].”

The Bayh-Dole Act also enabled the development of the profession of technology transfer with offices at most universities and research based non-profits across the United States, including Emory’s own Office of Technology Transfer (OTT). Thanks to Bayh-Dole, Emory OTT has had many success stories over the years, including the widely-used HIV antiretrovirals (emtricitabine & lamivudine), Factor VIII (rpfVIII, tradename Obizur®), or FACBC (tradename Axumin™)  Without the Bayh-Dole Act, the world today would look very different and the visionary research being done at universities like Emory would never be translated into products, medicines, and therapies that shape the world we live in today.

References

[1] https://www.bio.org/articles/academic-industry-patent-licensing-contributed-118-trillion-us-economy-1996-0

[2] https://www.autmvisitors.net/sites/default/files/documents/BRIDGES%20Winter%202016.pdf

[3] http://humanpoc.com/joe-allen/

[4] http://www.economist.com/node/1476653