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Welcome to the Center for Regulatory Strategies blog. We developed this platform to promote the sharing of insights, experiences and perspectives on the latest regulatory developments and trends in the financial services, energy and resources, life sciences and health care industries.

The Center for Regulatory Strategies delivers detailed and thoughtful insights from a powerful team of former regulators, industry specialists and trusted business advisers. We encourage you to participate in the discussion with our Center for Regulatory Strategies leadership team and your peers.

Featured insights

New! Eighth Annual Regulatory & Risk update

This blog series highlights themes from Deloitte's recent eighth annual Financial Services Regulatory & Risk Update that took place in the late Spring.

New! Hot off the press: FDA strategic priorities

Just before the July 4th weekend, the U.S. Food and Drug Administration (FDA) released a draft of its strategic priorities for the next four years. In case you were busy celebrating the holiday and didn’t have a chance to read through all forty pages of the report, here is a quick recap of some of the goals the FDA will be focusing on between now and 2018.

New! Highlights from the 2014 compliance week conference

Deloitte recently presented at the 2014 Compliance Week Conference in Washington, D.C., which drew top executives and compliance professionals from leading companies across a wide range of industries. Explore hot topics discussed during the conference.

Financial Services

New! Eighth annual regulatory & risk update
Thomas Rollauer, Executive Director, Center for Regulatory Strategies
Deloitte & Touche LLP

The annual Deloitte and Compliance Week survey results found some level of improvement in addressing compliance risks; however, there is still a burning need for organizations to improve how they handle their compliance activities.

Regulatory Liaison Office: Savvy investment or basic necessity?
Peter Reynolds, Director, Deloitte & Touche LLP
In today's challenging regulatory environment, a new corporate role of regulatory liaison with staff to support it is emerging to provide a central point of contact for the regulatory community.

Four observations on how financial institutions are "getting to strong"
Deborah Bailey, Director, Governance, Regulatory & Risk Strategies
Deloitte & Touche LLP

As you know, regulators are pushing banks, systemically important financial institutions (SIFIs) and other organizations to raise their risk management programs to a "strong" rating.

Life Sciences and Health Care

New! Hot off the press: FDA strategic priorities
Seth Whitelaw, Director, Deloitte & Touche LLP
Just before the July 4th weekend, the U.S. Food and Drug Administration (FDA) released a draft of its strategic priorities for the next four years. In case you were busy celebrating the holiday and didn’t have a chance to read through all forty pages of the report, here is a quick recap of some of the goals the FDA will be focusing on between now and 2018.

Follow then lead
Kelly Sauders, Partner, Deloitte & Touche LLP
Retailers expanding into health and wellness should start by looking to the health care industry for initial inspiration and insight.

Physician arrangements
Kelly Sauders, Partner, Deloitte & Touche LLP
As a result of entering into contractual agreements with non-hospital employed physicians and other ancillary providers, hospitals are dealing with increased regulatory scrutiny.

Making progress on health insurance exchanges without definitive guidance
Kelly Sauders, Partner, Deloitte & Touche LLP
Health plans are waiting for CMS (The Centers for Medicare and Medicaid Services) to provide detailed requirements and guidance about participating in federal health insurance exchanges. In the meantime, we believe their leading bet is to refer to the managed care manuals for Medicare Part C and D.

Risks and challenges of expanded retail pharmacy offerings
Kelly Sauders, Partner, Deloitte & Touche LLP
Many retailers are considering expanding their pharmacy offerings to tap into bigger margins and new revenue sources.

Sunshine Act compliance efforts continue to chug along
Seth Whitelaw, Director, Deloitte & Touche LLP
The Physician Payment Sunshine Act (“Sunshine Act”) has a lot of moving parts and compliance — is without doubt — a complex undertaking. As the March 31st reporting deadline looms large, we have seen that complexity manifest itself in the communications coming out of the Centers for Medicare and Medicaid Services(“CMS”).

Congress boosts funding to improve 340B program integrity
Ray Albertina, Director, Deloitte & Touche LLP
Marcy Imada, Principal, Deloitte & Touche LLP
Congress recently appropriated an additional $6 million to enable the Health Resources and Services Administration (HRSA) and Office of Pharmacy Affairs (OPA) to expand existing program integrity efforts for 340B drug pricing.

CMS proposes significant policy changes for the 2015 Medicare Advantage and Prescription Drug programs
Kelly Sauders, Partner, Deloitte & Touche LLP
There is a lot of information to wade through and  the new provisions could affect many different parts of the business — from costs and budgeting to operational processes and resource planning — so it makes sense to get started right away.

Medicare claims at risk
Kelly Sauders, Partner, Deloitte & Touche LLP
The Centers for Medicare and Medicaid Services (CMS) have now started to implement their long-anticipated Risk Adjustment Data Validation (RADV) audits. How can this impact health plans?

Getting ready for UDI in medical devices
Larry Spears, Director, Deloitte & Touche LLP
On September 24, 2013, the U.S. Food and Drug Administration (FDA), published its long-anticipated unique device identification (UDI) regulation. There's a lot to do and  the clock is ticking. It's time to get started.

Responding to medicare's new short stay rules
Kelly Sauders, Partner, Deloitte & Touche LLP
The Centers for Medicare & Medicaid Services' (CMS) new '2 midnight rule' has tremendous financial and operational implications and  should be addressed immediately.

Four actions you can still take to begin Sunshine Act compliance
Seth Whitelaw, Director, Deloitte & Touche LLP
August 1st has come and gone and the Physician Payment Sunshine Act ("Sunshine Act") has now gone live. Have you started tracking payments and other "transfers of value" to physicians and teaching hospitals? If not, I have two words for you: Don't panic.

Energy and Resources

Front and center 
Paul Campbell, Principal, Deloitte & Touche LLP
What are energy companies doing to address their compliance challenges and how can they stay ahead of regulatory trends and requirements without creating unnecessary drag on the business? This blog entry provides an overview of the Fifth Annual Energy Regulatory Compliance Survey results.

Linking pay to regulatory compliance in the energy industry
Paul Campbell, Principal, Deloitte & Touche LLP
As regulators in the energy industry expand their role and impact, a growing number of energy companies are warming up to the idea of explicitly tying executive and employee compensation to key performance indicators (KPIs).

Cross-Industry

New! Highlights from the 2014 compliance week conference
Nicole Sandford, Partner
Deloitte & Touche LLP

Deloitte recently presented at the 2014 Compliance Week Conference in Washington, D.C., which drew top executives and compliance professionals from leading companies across a wide range of industries. Explore hot topics discussed during the conference.

2014 Compliance trends survey report 
Thomas Rollauer, Executive Director, Center for Regulatory Strategies
Deloitte & Touche LLP

The annual Deloitte and Compliance Week survey results found some level of improvement in addressing compliance risks; however, there is still a burning need for organizations to improve how they handle their compliance activities.

Top regulatory trends for 2014
Thomas Rollauer, Executive Director, Center for Regulatory Strategies
Deloitte & Touche LLP

The Deloitte Center for Regulatory Strategies is producing a series of reports that discuss the top regulatory trends for 2014 in five key industries: energy, banking, securities, insurance and life sciences.

New survey: Companies advance their compliance programs, but a long road remains
Thomas Rollauer, Executive Director, Center for Regulatory Strategies
Deloitte & Touche LLP

In a joint effort with Compliance Week, our newly released In focus: 2013 Compliance Trends Survey shows the progress that companies worldwide have made in building and managing their compliance programs — and it's a mixed bag.