On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more
On January 20, 2015, as part of his State of the Union address, President Obama announced the upcoming launch of the White House’s Precision Medicine Initiative (Initiative). The Initiative seeks to allocate $215 million in...more
3/5/2015
On February 27, 2015, the Obama White House released an “Administration Discussion Draft” of its Consumer Privacy Bill of Rights Act of 2015 (Proposed Consumer Privacy Act). ...more
As we reported in May 2014, the Federal Trade Commission (FTC) convened stakeholders to explore whether health-related information collected from and about consumers — known as consumer-generated health information (CHI) —...more
In This Issue:
- The President’s Plan for Securing Cyberspace
- The President’s Plan for Safeguarding American Consumers and Families
- Conclusion
- Excerpt from The President’s Plan for Securing...more
What privacy, advertising and digital media trends will make headlines in 2015? Digital Health for one, Big Data for another....more
In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission...more
12/11/2014
/ Africa ,
Anti-Spam Legislation ,
Canada ,
China ,
Cybersecurity ,
Data Protection ,
EU ,
EU Data Protection Laws ,
Federal Trade Commission (FTC) ,
Latin America ,
Legislative Agendas
On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued its final Medicare physician fee schedule rule for CY 2015 (the Final Rule), which also includes certain changes to the Sunshine Regulations. ...more
In the July 3, 2014, issue of the Federal Register, The Centers for Medicare & Medicaid Services (CMS) published the proposed calendar year 2015 Medicare physician fee schedule update (the Proposed Rule). The Proposed Rule...more
On May 1, 2014, the White House released two reports addressing the public policy implications of the proliferation of big data. The first report is by the Executive Office of the President, entitled “Big Data: Seizing...more
5/13/2014
/ Barack Obama ,
Big Data ,
Data Breach ,
Data Protection ,
ECPA ,
Healthcare ,
Legislative Agendas ,
Life Sciences ,
Privacy Laws ,
Privacy Policy ,
Public Policy
On Wednesday, May 7, the Federal Trade Commission (FTC) held the third of its Spring Seminars on emerging consumer privacy issues. This session focused on consumer-generated health information (CHI). CHI is data generated...more
On January 10, 2014, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to alter key components of the Medicare Advantage (MA) and Part D Programs (Proposed Rule). Understandably, the Proposed Rule...more
The U.S. Court of Appeals for the 11th Circuit recently ruled that a Florida law requiring nursing homes to disclose patient records of deceased patients was preempted by the Health Insurance Portability and Accountability...more
On January 25, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published a final rule (Final Rule) containing modifications to the privacy standards (Privacy Rule), security...more
2/21/2013
/ Business Associates ,
Covered Entities ,
Data Breach ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Enforcement ,
GINA ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Notice Requirements ,
OCR ,
PHI ,
Privacy Rule
Office of Civil Rights has released additional guidance addressing the de-identification of protected health information in accordance with the HIPAA Privacy Rule. Covered entities should review their current...more