Category Archives: Personalized Medicine

Subscribe to Personalized Medicine RSS Feed

Breaking Down Barriers Between Pre-clinical and Clinical Adoption of Personalized Medicine

Personalized medicine will change how health care is delivered and disease is prevented and treated. But first, how disease and health is defined, as well as the clinical development and adoption of new therapies must align with current theories of disease and treatment.… Continue reading this entry

Proving Utility, Demonstrating Value: How to Align the Moving Parts in Personalized Medicine Reimbursement

Of the many business, operational, legal, regulatory and clinical obstacles standing in the way of widespread delivery of personalized medicine, the single greatest challenge may lie in solving the reimbursement puzzle. Advocates of personalized medicine contend that it results in better care for the patient, as therapy is targeted specific to an individual, and that … Continue reading this entry

Forget Bigger Data – Personalized Medicine Needs Smarter Data to Reach its Full Potential

medicare telehealth
The advent of big data has helped enable the growth of personalized medicine. But if machine learning and analytics are to truly help transform health care, it won’t be through bigger data, but through harmonized, smarter data.… Continue reading this entry

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air.  Learn what you need to know quickly with these seven questions and answers. What do I Need to Know?… Continue reading this entry

Amarin Pharma Settles First Amendment Claims Against FDA: Potential Implications

Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading” statements about off-label uses for its omega-3 drug, Vascepa, violated Amarin’s right to engage in constitutionally protected speech. The underlying claims and settlement may have … Continue reading this entry

Precision Medicine - Even Medicare Will Pay For It!

President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. “Precision Medicine” and “Personalized Medicine” are often used as interchangeable terms. Sylvia Burwell, Secretary of the Department of Health and Human Services (HHS), … Continue reading this entry

What Does President Obama's $215 Million "Precision Medicine Initiative" Mean for Genetic Privacy?

We have all heard about the burgeoning opportunities tied to the development of precision medicine (also called “personalized medicine”), which includes the use of an individual’s genetic information to design targeted treatments. In fact, these opportunities are now receiving increased visibility due to President Obama’s recent push for a “Precision Medicine Initiative.” Privacy issues are of critical … Continue reading this entry

Happy Holidays!

Thank you for reading, subscribing and being a part of our blog community in 2014. We hope you have a happy holiday season and a wonderful new year! – The Health Care Law Today Team We will be back with new posts the week of January 5.… Continue reading this entry

Happy Thanksgiving!

The Health Care Law Today team is thankful for you, our readers and subscribers. Thank you all for reading, contributing to, and sharing our blog. We hope you have a safe and happy holiday. Have a great weekend!… Continue reading this entry

Privacy Issues in the Sharing of Genetic Information

Low cost sequencing of a patient’s genome and advances in the interpretation of a patient’s genetic information is promised to transform the delivery of health care. To date, much of personalized medicine has focused on the use of genetics and data analytics to match a patient to the best treatment, especially in the area of … Continue reading this entry

Evolving Healthcare Trends & Patents: Charting a Safe Course for Personalized Medicine

Rapid changes resulting from personalized medicine, including the ability to use individual patient biomarker data to generate a tailored treatment, are transforming healthcare.  New business structures are evolving in the healthcare marketplace to meet the need for integrating diagnostic data to deliver individualized patient treatment. Diagnostic and therapeutic businesses are forming increasingly complex contractual arrangements … Continue reading this entry