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Do You Really Know Your China Telemedicine Partners? China Anti-Corruption Effort Focuses on Major Medical Institutions

This post is the fourth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market....more

The U.S. Complaint Against the Government of China in the WTO, Including the Targeting of Chinese Medical Device Manufacturers

On February 11, 2015, the United States filed a complaint before the World Trade Organization (WTO), alleging that certain actions by the national, regional and local governments of the People’s Republic of China are in...more

European Clinical Trial Regulations Public Consultation – Confidentiality Concerns

Clinical Trial Regulations - On 21 January 2015, the European Medicines Agency (EMA) began a public consultation on the new European Clinical Trial Regulations (CTRs)....more

New Russia Law Sets Tougher Penalties on Medicines and Medical Devices

On December 31, 2014 Federal Law No. 532-FZ was enactedOn Amending certain Legislative Acts of the Russian Federation in Connection with Interdiction of Falsified, Counterfeit, Poor-Quality and Unregistered Medicines, Medical...more

Health Alert (Australia) - February 9, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Western Australia (WA) - 29 January 2015 - Yoong And Medical Board Of Australia [2015] WASAT 6 - National Law -...more

FDA Requests Comments on WHO Recommendation to Classify Two Common Industrial Solvents as Psychotropic Substances

On January 27, 2015, the Food and Drug Administration (“FDA”) requested comments on a recommendation by the World Health Organization (“WHO”) to classify two common industrial solvents – gamma-butyrolactone (“GBL”) and...more

Health Alert (Australia) - February 2,2015

In This Issue: Judgments; Legislation; and Reports & Publications. - Excerpt from Judgments: New South Wales (NSW) - Janet Harris v Sydney Local Health District [2014] NSWDC 21 - The...more

Health Alert (Australia) - January 27, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: Ensuring National Capacity in Genomics-Guided Public Health Laboratory Surveillance. Australia. Department of Social...more

Privacy Tuesday - January 2015

Good Tuesday – The East Coast prepares for Apocalypse (Sn)ow. In the meantime, here are three privacy-related tidbits for your day. Privacy Concerns Cause Scale Back of Release of HealthCare.gov Data - We...more

Ensuring Data Protection In The Implementation Of The EFPIA Disclosure Code: Key Challenges And How Pharmaceutical Companies Are...

The EFPIA Disclosure Code will, from 2016, require pharmaceutical companies to disclose details of payments and transfers of value made to healthcare professionals and healthcare organisations. The Code aims to promote,...more

Healthcare & Life Sciences Private Equity Deal Tracker: CardioDx Secures $35 Million in Financing

CardioDx, headquartered in Redwood City, Calif., is a molecular diagnostics company specializing in cardiovascular genomics. Participants in this round of financing included Alberta Investment Management Corp. and the...more

Health Alert (Australia) - December 22, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 19 December 2014 – Dr Reid v Medical Council of NSW - [2014] NSWCATOD 152 - The Medical Council...more

China Issues Draft Guidance on Multi-Regional Clinical Trials

On November 21, 2014, China Food and Drug Administration (“CFDA”) released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) (“Guidance”) for public comments through December 21. The Guidance aims to set forth...more

Realizing the Potential of Telemedicine in China, Part 2: Data Privacy and Security

The Chinese market presents a tremendous opportunity for U.S. hospitals and providers, as long as the intricacies of data privacy and security issues are thoroughly understood. This includes Chinese regulations regarding...more

25 Ways Manufacturers Can Drive Profitability

Cohen & Company recently hosted “25 Way to Drive Profitability,” a workshop in Youngstown geared specifically toward manufacturers. Beginning with an overview by Rick Schiraldi of the Valley’s manufacturing roots and history,...more

Red Notice Newsletter - October 2014

Welcome to the October 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. - This month on the anticorruption front, a Texas company agrees to pay more than $5 million to settle allegations...more

Health Alert (Australia) - November 3, 2014

In This Alert: Judgments; Legislation; and Reports. Excerpt from Legislation: Dental Benefits Legislation Amendment Bill 2014 passed both house 30 October 2014 Amends the Dental Benefits Act 2008 and...more

Africa Update - October 2014 #5

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from...more

China to Open Up Its Hospital Market to Foreign Investment on a Pilot Program

On August 27, 2014, the National Health and Family Planning Commission (“NHFPC”) and Ministry of Commerce (“MOFCOM”) jointly released Notice on Conducting Pilot Work of Setting Up Wholly Foreign Owned Hospitals) (“Notice”)...more

Health Alert (Australia) - October 27, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Queensland - 23 October 2014 - Vision Eye Institute Ltd v Kitchen & Anor [2014] QSC 260 In 2006, Kitchen sold...more

The New EU Clinical Trials Regulation Aims at Harmonization and Transparency

On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

China Widens Entry to Medical Device Market to Investment, Innovation While Tightening Regulations on Existing Market Products

As the medical device industry in China continues accelerated growth, investors seek to capitalize on a roughly $65 billion market that is growing at an annual rate of 21 percent. Under recent changes to the regulatory...more

Africa Update - October 2014 #2

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from Leading the...more

Realizing the Potential of Telemedicine in China, Part 1: Protecting Your IP

This post is the second in Foley’s blogs on China telemedicine and the first in the blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the...more

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