Medical Devices Healthcare

News & Analysis as of

Key Digital Health Investment Trends to Watch

Our fourth annual Digital Health Summit brought together a select group of investors active in the digital health, life sciences, medical device, and healthcare industries for a one-day meeting to discuss the future of...more

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

OIG Reviews Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors (PODs) of Spinal Devices

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a report on “Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors.” The OIG reviewed 12 hospitals that...more

Mechanical Ventilation Innovation Challenge

According to press releases, the American Association for Respiratory Care (AARC) and Edison Nation Medical have partnered to search for innovations for improving the process, outcomes, and comfort for patients requiring...more

Washington Healthcare Update

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

China’s State Council Announces Reform on the Drug and Device Approval System

China will launch new reforms of its current review and approval system for drugs and medical devices, announced by China’s State Council, in its August 18, 2015, circular Opinions Concerning the Reform of the Review and...more

Mobile Health Devices and Cybersecurity: Federal Guidance for Management of Threats in Medical Devices

New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more

China's Medical Device Market: New Policies, Higher Stakes

The recent introduction of the Regulations on the Supervision and Administration of Medical Devices (also known as State Council Order 650) has created significant impact in the medical device industry in China. The changes...more

FDA issues first medical device hacking alert

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more

HHS IT security found to be weak

The House of Representatives Energy and Commerce Committee issued a report late last week that the information security of the Department of Health and Human Services (HHS) has substantial weaknesses. Several incidents that...more

FDA's Cybersecurity Alert Puts Medical Device Users on Notice

On July 31, 2015, the United States Food and Drug Administration (FDA) issued a cybersecurity alert to health care facilities currently using certain infusion pumps manufactured by Hospira, Inc. The alert warns health care...more

Orthofix Deferred Prosecution Agreement Extended for Two Months

In a recently-filed status report, the DOJ and medical device manufacturer Orthofix revealed that the company’s Deferred Prosecution Agreement (DPA) will be extended by two months. The DPA was due to expire on July 17, 2015,...more

Washington Healthcare Update

This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more

Private Equity Investment in Healthcare: 15 Healthcare Investment Niches – A Review of Key Sectors for 2015

Private equity investment in healthcare continues to grow considerably. This article provides thoughts, observations and insights on 15 investment niches. It also provides some initial thoughts on the market as a whole....more

President Obama Signs Steve Gleason Act and Independence at Home Act

On July 30, 2015, President Obama signed into law: ..S. 984, “Steve Gleason Act of 2015” – a bill to cover as durable medical equipment eye tracking and gaze interaction accessories for speech generating devices...more

House Passes Medical Innovation Bill That Would Revise HIPAA

On July 10, the U.S. House of Representatives approved the 21st Century Cures Act (the Act), a bill intended to support advancements in medical innovation. The Act includes measures aimed at spurring medical research,...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

ABA Resolution 105 on Punitive Damages Is Dead for Now

On the eve of the ABA's Annual Meeting next week, the ABA's Standing Committee on Medical Professional Liability announced its withdrawal of proposed Resolution 105 from consideration by the ABA House of Delegates. The...more

Medicare, Medicaid, and Enforcement Implications of the 21st Century Cures Act Recently Passed by the House

On July 10th, the U.S. House of Representatives passed the 21st Century Cures Act – medical innovation reform legislation that has been in the works for over a year – by a wide margin (344-77). As Ropes & Gray previously...more

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

Georgia Senator Introduces The Combination Product Regulatory Fairness Act of 2015

On July 17, 2015, Georgia’s U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a Senate bill entitled, “The Combination Product Regulatory Fairness Act of...more

Recent Ninth Circuit En Banc Decision Makes It Easier for Relators to be an Original Source and the First- to-File

On July 7, 2015, the United States Court of Appeals for the Ninth Circuit issued an en banc decision that potentially makes it easier for relators to prevail on pending False Claim Act qui tam suits and bring new actions in...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

Congress Clears Bipartisan DME & Home Care Bills

On July 15, 2015, the House of Representatives approved by voice vote the following two bills...more

Washington Healthcare Update

This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more

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