The Seventh Circuit held yesterday, in a decision written by Judge Posner, that damages are not available under the Video Privacy Protection Act (“VPPA”) for violations of the statute’s data deletion requirement, only for unlawful disclosures of video-viewing information. Subsection (b) of the VPPA prohibits knowing disclosure of personally identifiable information that identifies a person
March 2012
HHS Publishes Standards for Health Care Electronic Funds Transfers and Remittance Advice
The Department of Health and Human Services (HHS) recently published an interim final rule with comment period entitled “Administrative Simplification: Adoption of Standards for Health Care Electronic Funds Transfers (EFTs) and Remittance Advice.” The rule establishes streamlined standards for the format and content of transmissions that health plans send to financial institutions when making…
Belgium – Regulatory Overview
Article originally published in the Life Sciences Handbook, 2012
1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?
Legislation
The main legislative acts regulating medicinal products are the:
- „„ Medicines Law 1964.
- „„ Royal Decree of 14 December 2006 on
…
Key Considerations for European M&A in the Life Sciences Sector
Article originally published in PLC Life Sciences Handbook 2012
M&A in the life sciences sector has remained robust, driven by factors such as:
- „„ The need to replenish shrinking product pipelines.
- „„ The need to maintain revenues as patents on top-selling
- products expire.
- „„ The strategic diversification of business lines.
- „„ Expansion into emerging markets.
…
NTIA Seeks Comment on Beginning Conduct-Code Discussions
The Department of Commerce’s National Telecommunications and Information Administration (NTIA) sought public comment Wednesday on how to begin the process of developing voluntary codes of conduct governing consumer privacy, as called for in the privacy framework released by the White House last month. That report argues that companies should follow seven basic principles —…
Republican Senators Introduce SECURE IT Act
Yesterday Senator John McCain (R-AZ) introduced the Strengthening and Enhancing Cybersecurity by Using Research, Education, Information, and Technology Act of 2012 (SECURE IT Act). The bill’s cosponsors include Senators Kay Bailey Hutchison (R-TX), Chuck Grassley (R-IA), Saxby Chambliss (R-GA), Lisa Murkowski (R-AK), Dan Coats (R-IN), Ron Johnson (R-WI), and Richard Burr (R-NC).…
Revision of the Rules on Pricing and Reimbursement of Medicines (The “Transparency Directive”) in the European Union
Originally published as Covington E-Alert on March 1st, 2012
Today the European Commission published its long awaited proposal for the revision of the so-called Transparency Directive. The Directive lays down procedural guarantees for the systems that regulate the pricing and reimbursement (“P&R”) of medicines in the thirty EU and EEA Member States. The revision aims…