Six Things to Know About Trademarks

Understanding trademarks and the rights they afford you, as well as understanding how to avoid trademark disputes, are essential to your success and the success of any of your brands or companies. This blog will give a brief overview of 6 essential things to know about trademarks and trademark laws to help aid your understanding of this subject. Trademarks are different from patents and copyrights: Trademarks, copyrights, and patents all protect intellectual property, but they all protect different types of intellectual property. A patent protects inventions, copyright protects original artistic or literary work, and trademarks are reserved for brand names Read More …

What is Informed Consent?

Informed consent is the process of obtaining a patient’s or participant’s permission prior to conducting a medical procedure or investigation on said person. It involves ensuring that the participant completely comprehends and agrees to the potential consequences of any procedures that they will undergo. Examples include, a health care provider asking their patient to consent to a surgical procedure before providing it, or a psychologist discussing information about the study with a future research participant prior to enrolling them into an experimental study. As such, informed consent is collected according to guidelines from the fields of medical ethics and research Read More …

The Institutional Review Boards 101

New discoveries of therapies and drug mechanisms are not always the daily news headline, but today ethical guidelines exist to continue to keep a standard of the production of any new medication or treatment. However, the history of clinical research has not always been so ethical. For instance, the PHS Syphilis Study in Tuskegee, AL and the Willowbrook Hepatitis Experiments, are only two of many notorious examples of horrifically unethical clinical trials. The purpose of this article is to bring light into the role of the Institutional Review Boards (IRB) in relationship to on ongoing  clinical trials today to ensure Read More …

Be Ware of Preprints: Protect Your Intellectual Property First

Who owns the rights to a new innovation described in a research paper? If a patent is in place, the answer is simple: the owner. Generally, the lengthy, and confidential, peer-review process means that authors of unpublished work have ample time to submit an invention disclosure and to have their technology transfer office review and if necessary, file a patent, ensuring that any new invention is protected prior to any public disclosure. However, the rise of “preprint” services, which allow authors to publish preliminary findings ahead of peer-review, has complicated this process. Preprints can severely hamper the ability of authors Read More …

What is PHI?

PHI stands for Protected Health Information and encompasses all information acquired during health care services that could potentially be used to identify an individual. PHI does not only include medical records, but also communications between medical personnel regarding treatment, billing information and health insurance reports. For information to be formally considered PHI under the law, it must be created, received, stored, or transmitted by HIPAA-covered entities. Under the Health Insurance Portability and Accountability Act (HIPAA), covered entities are limited in the types of PHI they can collect from individuals, share with other organizations or use in marketing. HIPAA-covered entities include Read More …

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 Read More …

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 Read More …

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 Read More …

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 Read More …

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 Read More …