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Healthcare & Life Sciences Private Equity Deal Tracker: Shockwave Medical Secures $40 Million in Financing

Shockwave Medical, based in Fremont, Calif., develops technology for the treatment of peripheral and coronary vascular disease and aortic stenosis. It is the developer of Lithoplasty balloon catheters....more

Justice to Target Corporations and C-Suite Executives in the Healthcare Industry

On Thursday, May 14, 2015, at a meeting of the American Bar Association’s Healthcare Fraud Section, Leslie Caldwell, the Assistant Attorney General for the Department of Justice (DOJ) Criminal Division, declared stamping out...more

Healthcare & Life Sciences Private Equity Deal Tracker: Precision BioSciences Secures $25.6 Million in Financing

Precision BioSciences is a Durham, N.C.-based genome editing company. Its ARCUS genome editing technology is designed to produce nucleases that can insert, remove and modify DNA in a complex genome....more

Healthcare & Life Sciences Private Equity Deal Tracker: Rapid Micro Biosystems Secures $25 Million in Financing

Rapid Micro Biosystems, based in Lowell, Mass., develops imaging technology that detects microbial contamination in the manufacture of pharmaceutical, biotechnology and other products....more

Blog: HIPAA FAQ Series: Do You Need a BAA with Your Cloud Storage Provider?

This week, the HIPAA FAQ series continues with another topic about business associate agreements (BAAs). As most Covered Entities and Business Associates know, in the event that a Covered Entity utilizes a service provider...more

Novartis and Qualcomm Form Digital Health Investment Company

Novartis Pharmaceuticals has announced it has formed a joint investment company with Qualcomm Ventures, the venture investment group of Qualcomm....more

CMS Announces Latest Group Of MSSP ACOs And May Allow ACOs To Remain As “Upside-Risk Only” Longer

December has been a busy month for CMS with respect to the Medicare Shared Savings Program (“MSSP”). Last week CMS announced that eighty-nine (89) more ACOs would begin participating in the MSSP starting in 2015, bringing the...more

Department Of Health And Human Services Issues Proposed New Rules Implicating The Use Of Electronic Health Records And Patient...

On December 8, 2014, the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule related to changes to the Medicare Shared Savings Program. These revisions promote the use of electronic health records by...more

Health Law Pulse - October 2014 # 2

In This Issue: - OIG Releases Proposed Rule Revising the Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules ..AKS Safe Harbors ..Revisions to the Civil Monetary Penalty...more

Health Update - August 2014 #5

The Five Megatrends Shaping Pharma’s Next Decade: Sustaining Success in a New Market Landscape - Disruptive trends in the healthcare system will force companies to change their strategies. With new care models...more

Health Update - July 2014

Avoiding the Regulatory Land Mines of Commercial ACOs - While providers are showing great interest in creating ACOs to participate in the Medicare Shared Savings Program (MSSP), they are showing even greater enthusiasm...more

How is Graphene Currently Used and What is the Hope for the Future? [Video]

In the second video of a three-part series, Fenwick attorney Paul Smith talks about the growing anticipation surrounding this strong, conductive and flexible material. Why the excitement? Simply put, graphene is easy. It’s...more

What is Graphene? Fenwick Patent Attorney Has the Answer [Video]

The technology and life sciences communities alike have been raving about new "wonder material" graphene for the past year. From applications for wearable devices to the creation of lightweight, bendable televisions and...more

Two Tips for Inventors Filing Patent Applications [Video]

The intense patent activity in graphene stems from its enormous technological and commercial potential. But because much of the territory underlying the graphene cross-roads has already been claimed, patenting graphene poses...more

FDA Plays Catch Up in the Digital Age

Part of JD Supra's series on innovation and the law. A look at how, as pharmaceutical manufacturers increasingly turn to social media to exchange information, laws and regulations that are decades old struggle to keep pace...more

Perspectives - January 2014

In This Issue: - Considerations in the Cloud: Managing the Risks - United States V. Sperry: A Revived Threat to Owners, Directors, Managers and Directors of Distressed Organizations - Board Membership &...more

Health Update - Jan 27, 2014

Going Digital with Patients: Managing Potential Liability Risks of Patient-Generated Electronic Health Information - Patients are increasingly using new electronic tools, such as personal health records and mobile...more

HHS-OIG Corporate Integrity Agreements Are Now Aiming at Corporate Directors and Executives

Corporate integrity agreements (CIAs) are a familiar feature of many civil False Claim Act and joint civil/criminal resolutions in healthcare fraud cases. These agreements are entered into between the defendant company and...more

Innovative Exit Strategies for Life Sciences Companies – Interview with Bill Whelan, Member, Mintz Levin [Video]

Attorney Bill Whelan, Co-chair of Mintz Levin's Life Sciences Practice, discusses exit strategies in the life sciences....more

The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin [Video]

Attorney Karen Lovitch, Practice Leader of Mintz Levin's Health Law Practice, discusses the challenges facing pharmaceutical and medical device manufacturers in complying with the Sunshine Act....more

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

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

Physician Payment Sunshine Act Final Rule Released

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]

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

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

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]

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

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