Science, Computers & Technology, Health Law, Business Organization

Cloud Storage Providers Storing Protected Health Information May Be Obligated to Comply with HIPAA Regulations

by Wilson Sonsini Goodrich & Rosati on 4/17/2013

A recently issued government rule may unknowingly create significant liability and legal risk for many technology enterprises. The expanded definition of "business associates" and related interpretations by the Department of...more

A Look at Angel Investment Trends from 2012

by The R. Bernard Law Group on 4/17/2013

Entrepreneurs seeking angel funding should pay special attention to the recent Halo Report, a joint release by Silicon Valley Bank, CB Insights and Angel Resource Institute. The report looks at 783 deals including angel...more

Physician Payment Sunshine Act Final Rule Released

by Thomas Donohoe, Lauren Groebe, Lindsay Kessler, Matthew Murer | Polsinelli on 3/7/2013

In This Issue: - Interpretation and Clarification of Key Definitions ..Applicable Manufacturers ..Applicable GPOs ..Covered Drug, Device, Biological or Medical Supply ..Covered Recipients ...more

Digital Health: Revolutionizing Healthcare [Video]

by Michael Esquivel | Fenwick & West LLP on 2/6/2013

What is digital health? What sort of action is digital health seeing? According to Fenwick client and digital health incubator Rock Health, digital health funding was up 65 percent mid-year in 2012 and up 45 percent over the...more

HIPAA Final Omnibus Rule Brings “Sweeping Change” to Health Care Industry

by Matthew Arend, Jennifer Mitchell | Dinsmore & Shohl LLP on 1/21/2013

On January 17, 2013, the U.S. Department of Health and Human Services (HHS) announced the release of the HIPAA final omnibus rule, which was years in the making. The final rule makes sweeping changes to the HIPAA compliance...more

One Week to Get Business Associate Agreements Executed Under HIPAA Omnibus Rule’s Grandfather Clause

by Adam H. Greene, Rebecca L. Williams | Davis Wright Tremaine LLP on 1/21/2013

On Jan. 17, 2013, the long-awaited HIPAA “Omnibus Rule” went on display at the Federal Register, finalizing changes to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules....more

Hot Companies in Digital Health [Video]

by Michael Esquivel | Fenwick & West LLP on 1/11/2013

With venture capital funding of digital health up 45 percent in 2012, according to Rock Health, we’re hearing a lot about mobile health apps and healthcare IT. You may be asking yourself what is digital health? Michael...more

Digital Health: Where is the Action for Entrepreneurs? [Video]

by Michael Esquivel | Fenwick & West LLP on 1/10/2013

As CES 2013 draws to a close, Michael Esquivel, a partner in Fenwick’s Start-ups and Venture Capital Group, identifies where the action is for entrepreneurs and investors in digital health and healthcare IT. According to...more

Articles in Legal Industry Publications Continue to Qualify as Public Disclosure Under the False Claims Act

by Mintz Levin - Health Law on 9/12/2012

A Texas federal judge recently tossed a Federal False Claims Act (FCA) qui tam because the substance of the underlying allegations was previously disclosed in several legal industry publications, U.S. ex rel. Pharma Fraud...more

Health Innovation Summit Begs the Question - Is Digital Health at a Tipping Point?

by Fenwick & West Life Sciences Group on 8/31/2012

From the minute you stepped off the elevator at Rock Health’s annual Health Innovation Summit on Tuesday, there was an undeniable energy. The sold out event was jam-packed with entrepreneurs, investors and health and...more

Telemedicine Amidst Healthcare Reform: Practicalities and Pitfalls

by CMCP - California Minority Counsel Program on 7/31/2012

The Supreme Court’s recent decision upholding the Patient Protection and Affordable Care Act underscores the need to deliver and make accessible quality healthcare to patients throughout the United States in an efficient and...more

Venture Investment in Digital Health Effectively Doubles in H1 2012

by Fenwick & West Life Sciences Group on 7/30/2012

Venture investment in healthcare convergence technologies soared in the first half of 2012. According to a recent report from Burrill & Co, digital health, into which they group healthcare IT, mobile health and wireless...more

340B Drug Pricing Program Experiencing Unprecedented Compliance Scrutiny

by Polsinelli on 7/18/2012

Participants in the 340B Drug Pricing Program (340B Program) should be aware that over the last several months, the 340B Program has witnessed an unprecedented focus on oversight, integrity and enforcement. Although the 340B...more

Medical Device Compliance Solutions - May 2012

by Butler, Snow, O'Mara, Stevens and Cannada,... on 5/30/2012

In This Issue: - Risky Business? Assessing Risks with A Risk Assessment Checklist - Haunting Prose: Ghostwriting and Transparency in Pharmaceutical and Medical Device Publications - 2012 In The Line Of Fire:...more

G2 Compliance Report -- Keeping the Whistle Away From the Whistleblower: The Laboratory Compliance Officer’s Role in Qui Tam...

by Mintz Levin - Life Sciences on 5/21/2012

Do you, as a laboratory compliance officer, want to spare your employer the disruption, expense, and burden of a government enforcement action? The answer, of course, is “yes.” The most effective and efficient way of doing so...more

Evolution and Refinement: Recent Texas Legislative Efforts on Medical Records, Corporate Practice, and Other Issues

by Jackson Walker on 2/13/2012

In This Presentation: Question 1: • If a physician complies with HIPAA, he or she has also complied with all requirements of Texas’ medical privacy laws. • True •...more

The HIPAA Auditors Are Coming. Are You Ready?

by Ropes & Gray LLP on 2/6/2012

On June 10, 2011, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) awarded KPMG a $9.2 million contract to develop a pilot HIPAA audit program mandated under the HITECH...more

"Pharma/Device Enforcement: A Year in Review"

by Skadden, Arps, Slate, Meagher & Flom LLP on 1/19/2012

We are pleased to provide "Pharma/Device Enforcement: A Year in Review," Skadden's annual look at trends in the sector. This year's edition includes details on 2011 DOJ settlements, FDA enforcement trends, enforcement...more

Health Reform: CMS Issues Proposed Rules on Federal "Sunshine" Law for Manufacturers and GPOs

by Epstein Becker & Green, P.C. on 12/19/2011

On December 14, 2011, the Centers for Medicare & Medicaid Services (“CMS”) issued long-awaited proposed rules with a lengthy preamble (collectively referred to herein as “Proposed Rules”) relevant to Section 6002 of the...more

HHS OIG Recommends New Federal Regulations to Govern NIH Grantee Institutions

by King & Spalding on 1/31/2011

According to OIG, NIH lacks information on institutional conflicts and the impact these conflicts may have on NIH sponsored research Summary The Office of Inspector General (OIG) for the U.S. Department of Health...more

New Guidance on the OIG’s Ability to Exclude Owners, Officers and Managing Employees; Related FDA Statements on Pharmaceutical...

by Reed Smith on 11/1/2010

On October 20, 2010, the Office of Inspector General (OIG) of the Department of Health and Human Services issued significant new guidance for implementing its permissive exclusion authority under Section 1128(b)(15) of the...more

HHS Issues Guidance on Risk Analysis Required by HIPAA Security Rules

by Katten Muchin Rosenman LLP on 5/20/2010

The U.S. Department of Health and Human Services (HHS) has issued draft Guidance on Risk Analysis for covered entities and business associates. This guidance was issued, in part, to fulfill HHS’s mandate under the Health...more

Health Care Reform Advisory: Update on the Billion-Dollar Tax Credit and Grant Opportunity: What Life Sciences Companies Can Do...

by Mintz Levin - Health Law on 4/30/2010

In a recent advisory, we reported that the Patient Protection and Affordable Care Act (a.k.a. the health care reform bill) includes $1 billion in tax credits and grants to defray the costs of therapeutic research by small and...more

Health Care Reform Advisory: Billion-Dollar Tax Credit and Grant Opportunity for Life Sciences Companies

by Mintz Levin - Health Law on 4/7/2010

Among the varied provisions in the voluminous Patient Protection and Affordable Care Act, a/k/a the Health Care Reform Bill, Congress has appropriated up to $1 billion in tax credits and grants to defray the costs of...more

Physician Payment “Sunshine Provisions” Signed into Law as Part of Health Care Reform Legislation

by Ropes & Gray LLP on 3/30/2010

On March 23, President Obama signed into law the Patient Protection and Affordable Health Care Act (H.R. 3590) (the “Act”), which includes new “Sunshine Provisions,” requiring pharmaceutical, medical device, biological, and...more

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Science, Computers & Technology › Health Law › Business Organization

Cloud Storage Providers Storing Protected Health Information May Be Obligated to Comply with HIPAA Regulations

A Look at Angel Investment Trends from 2012

Physician Payment Sunshine Act Final Rule Released

Digital Health: Revolutionizing Healthcare [Video]

HIPAA Final Omnibus Rule Brings “Sweeping Change” to Health Care Industry

One Week to Get Business Associate Agreements Executed Under HIPAA Omnibus Rule’s Grandfather Clause

Hot Companies in Digital Health [Video]

Digital Health: Where is the Action for Entrepreneurs? [Video]

Articles in Legal Industry Publications Continue to Qualify as Public Disclosure Under the False Claims Act

Health Innovation Summit Begs the Question - Is Digital Health at a Tipping Point?

Telemedicine Amidst Healthcare Reform: Practicalities and Pitfalls

Venture Investment in Digital Health Effectively Doubles in H1 2012

340B Drug Pricing Program Experiencing Unprecedented Compliance Scrutiny

Medical Device Compliance Solutions - May 2012

G2 Compliance Report -- Keeping the Whistle Away From the Whistleblower: The Laboratory Compliance Officer’s Role in Qui Tam...

Evolution and Refinement: Recent Texas Legislative Efforts on Medical Records, Corporate Practice, and Other Issues

The HIPAA Auditors Are Coming. Are You Ready?

"Pharma/Device Enforcement: A Year in Review"

Health Reform: CMS Issues Proposed Rules on Federal "Sunshine" Law for Manufacturers and GPOs

HHS OIG Recommends New Federal Regulations to Govern NIH Grantee Institutions

New Guidance on the OIG’s Ability to Exclude Owners, Officers and Managing Employees; Related FDA Statements on Pharmaceutical...

HHS Issues Guidance on Risk Analysis Required by HIPAA Security Rules

Health Care Reform Advisory: Update on the Billion-Dollar Tax Credit and Grant Opportunity: What Life Sciences Companies Can Do...

Health Care Reform Advisory: Billion-Dollar Tax Credit and Grant Opportunity for Life Sciences Companies

Physician Payment “Sunshine Provisions” Signed into Law as Part of Health Care Reform Legislation

Digital Health: Revolutionizing Healthcare [Video]

Hot Companies in Digital Health [Video]

Digital Health: Where is the Action for Entrepreneurs? [Video]

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