Christopher White

Christopher L. White, Esq. is Senior Executive Vice President and General Counsel of the Advanced Medical Technology Association (AdvaMed). He manages AdvaMed’s Legal Committee to develop and promote legal policy positions enhancing patient access to medical technology.  Mr. White leads the Association’s working groups on compliance, Physician Payment Sunshine, and device tax implementation. He testified before the Senate Aging Committee on the Physician Payment Sunshine legislation, led the drafting team substantially revising the AdvaMed Code in 2008-2009, and leads AdvaMed’s Code of Ethics related programs and activities.  He led the negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia. As chief legal officer, he also provides counsel on contracts, corporate transactions, tax exemption, HR, and legislative and regulatory matters.  He serves as a frequent speaker and author on health care regulatory and fraud and abuse issues.  

I recently sat down with Peter Blenkinsop , a Partner at DrinkerBiddle , an expert on data privacy and one of the panelists at our upcoming GMTCC Conference (Amsterdam, May 3-4), to get his take on the biggest privacy law challenges currently facing Medtech companies . Peter pointed to two trends that are changing the Medtech sector and provided insight on how privacy and data protection laws may impact those trends: Trend #1: Rapid growth of consumer generated and controlled health and wellness data Consumers now have an ever-increasing number of options for tracking their health and wellness between visits to the doctor. Mobile apps that enable consumers to monitor and manage their health are extremely popular. These apps allow consumers to track, share and utilize insights from data in a variety of ways and can be integrated with other systems including medical devices and electronic health records. This has resulted in an explosion of consumer health data that could be put to many beneficial uses. For example, researchers could harness this data collection for a particular person and ‘go back in time’ after a patient experiences a serious medical event to better understand what signals were present that may have foreshadowed the event. They could then leverage those learnings to alert similar individuals in the future who exhibited the same signs, perhaps averting a medical emergency. The accessibility of such data to researchers in the first place hinges on one thing: trust . If consumers don’t trust app and device makers to use their data appropriately, then they won’t share it. Trend #2: Increasing demand for health outcomes and cost-effectiveness information Now, more than ever, payers want real-world evidence of the value of medical technologies they have agreed to cover. This requires the collection of data on comparative health...
Each fall the two of us meet to discuss global healthcare legal and compliance developments and to assess implications on the medical technology industry, patient care and innovation. When we first began collaborating the iPhone was just invented (healthcare apps were unimaginable) and, since that time, quite a bit has changed! When we annually meet, we reflect on member company input and surveys, leading health official statements and policies, medical professional societies and patient perspectives, business trends, and developments in other industries - a 360 degree review! From transparency to FCPA to the phase out of direct sponsorship we've analysed most developments shaping this field and tried to position our industry ahead of the curve when we could. The Global MedTech Compliance Conference , GMTCC in short, is our annual forum for global medtech compliance and ethics exchange on the trends and topics we see as most pressing to patients, industry and users. This is our industry’s opportunity to learn from each other, from thought leaders, and to continuously advance our work, just as our industry continuously drives ahead new patient care innovations. As an industry and legal/compliance experts we've achieved remarkable success - new guidance, distributor trainings, outreach to important stakeholders, including also international organisations such as OECD, small company boot camp, etc. - and our annual GMTCC dialogue among global leadership has been instrumental to this success. In past years we've focused on new law enforcement theories and assessed how we can lead industry to safety, preserve industry innovation and establish credible self-regulatory approaches through ethics and compliance guidance. When possible, we've tried to align our policy work to avoid regional fragmentation for a global industry dependent on global lines of scientific exchange. But, when we met last fall, and we again reflected on developments, trends, thought leader...
As a medtech lawyer, my focus naturally gravitates to assessing “downstream” relationships and risk; that is, analysis of the legal arrangements between manufacturers, distribution agents, and health care providers that together bring medical technologies to the patient’s bedside. These relationships can be complex, as are the legal issues they raise. But ensuring ethical standards in these relationships is critical, because patients deserve the confidence of knowing that the medical technologies used in their care are based on clinical consideration of what is best for them , not financial considerations or other such factors. Downstream arrangements in the medtech industry are governed by well-established authorities that are very familiar to health care lawyers, such as the anti-kickback statute, beneficiary inducement civil monetary penalty provisions, the foreign corrupt practices act, and in some cases distribution licensure. The law in this area is mature, and supplemented by extensive regulations, subregulatory guidance, and voluntary industry codes of ethics . When health care lawyers talk about “compliance,” they usually are referring to these downstream arrangements. But “upstream” compliance – relating to the supply chain that supports the production of medical technologies – is also emerging as a focus for the medtech industry. As I have mentioned before , I am constantly awed by the pace of medtech innovation in bringing sophisticated technological solutions, cures and treatments to patients—from nanotechnology, to robotics, to diagnostics, digital and beyond. These technological innovations utilize a range of materials, with associated supply chains that can be complex and global, even for small companies. Upstream ethics and compliance issues have been the subject of several important legal and policy developments. Here are a few trends--from other industrial sectors--that I'm watching: Materials sourcing/conflict minerals : Atrocities in the Democratic Republic of Congo (DRC) and adjoining countries financed by mineral trade have spurred...
As AdvaMed and Eucomed prepare for our next Global MedTech Compliance Conference May 20-22, 2014 in Barcelona, Spain, I reflect on the remarkable policy outcomes attributed to our past conference discussions. Our MedTech association-led compliance conferences offer a platform—not available in a commercial compliance conference—to spur discussion and best practices exchange among compliance leaders on issues most crucial to industry, engage in common training, forge consensus on policy priorities and drive industry compliance policy ahead to reach new achievements. This unique ability of association-led compliance conferences to drive change was evident during the recent Latin America Compliance Conference. At the conclusion of the Latin America Compliance Conference in São Paulo (11-13 February), four medical device associations acted on the passionate conference discussion and focus on Brazil’s new Clean Companies anti-bribery law, to jointly commit to advance business ethics in Latin America’s largest medical device market. Under the 13 February memorandum of understanding (MOU) AdvaMed and three key Brazil device associations will work together to enhance ethical business practices in Brazil among manufacturers, third-party distributors and healthcare professionals, representing a significant step toward harmonising codes of ethics across Latin America. Groups signing the MOU with AdvaMed include: Associação Brasileira da Indústria de Alta Tecnologia de Equipamentos, Produtos e Suprimentos Médico-Hospitalares ( ABIMED ); Associação Brasileira de Importadores e Distribuidores de Implantes ( ABRAIDI ); and Câmara Brasileira de Diagnóstico Laboratorial ( CBDL ). The MOU reflects the medical technology industry’s commitment to developing a cohesive international approach to interactions with health care providers, premised on the highest ethical standards. Interactions between medical technology companies and physicians are essential for the development of advanced, life-saving and life-enhancing medical technologies, for ensuring the safe and effective use of medical products, and for improving patient outcomes. By facilitating open and transparent business environments free...
AdvaMed and Eucomed are co-organizing the upcoming International Medical Device Industry Compliance Conference, taking place on 18-20 May in London. Both AdvaMed and Eucomed worked closely with our member companies to identify the hottest issues in medical device industry compliance today to shape a truly global, industry specific event. We also worked together to invite accomplished discussion leaders and moderators, and panel participants representing North American and European perspectives and experiences.