Filed under: Health Law, Information Technology
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Helen Oscislawski, Privacy Risk Assessments and Privacy Challenges
Helen Oscislawski is the founder of Oscislawski, LLC in Princeton. She provides legal guidance on HIPAA, HITECH, state privacy laws, electronic health information exchanges and health information technology to HIEs, RHIOs and ACOs, and counsels other healthcare clients in various matters.
Ms. Oscislawski was appointed by Governor Jon Corzine in 2008 to the New Jersey Health Information Technology Commission (NJHITC) and was reappointed to the NJHITC by Governor Chris Christie in 2010 where she also served as Chair of the Privacy and Security Committee for NJHIT Coordinator. She is the primary author of Update to Privacy and Security Compliance Manual, which was developed for the New Jersey Hospital Association and, most recently, she has developed and authored several editions of the HIPAA-HITECH Helpbook, a manual that combines tools and sample forms that address HITECH changes, state law and other considerations and Meaningful Use and Health Information Exchanges.
Before founding Oscislawski, LLC, Ms. Oscislawski was a healthcare attorney at Fox Rothchild in Princeton, New Jersey, where she counseled healthcare clients on a wide range of legal matters. She received her BA from Rutgers University, Douglass College and her JD from Rutgers School of Law.
Frank Pasquale, Professor of Law, Seton Hall Law School, The Past, Present and Future of Health Privacy
Professor Frank Pasquale is the Schering-Plough Professor in Health Care Regulation and Enforcement at Seton Hall Law School. Professor Pasquale has taught information and health law at Seton Hall since 2004. He has published over 20 scholarly articles. His research agenda focuses on challenges posed to information law by rapidly changing technology, particularly in the health care, internet, and finance industries.
Professor Pasquale is an Affiliate Fellow of Yale Law School’s Information Society Project. He has been named to the Advisory Board of the Electronic Privacy Information Center. He has served on the executive board of the Health Law Section of the American Association of Law Schools (AALS), and has served as chair of the AALS Section on Privacy and Defamation.
Professor Pasquale received his BA from Harvard University (summa cum laude), his M.Phil. from Oxford University, and his JD from Yale Law School.
Jaime S. Pego, Director, Healthcare Advisory Services, KPMG LLP, (along with Joy Pritts, Mark Swearingen, and Frank Pasquale, Moderator) Panel Discussion: The Practical Steps Necessary to Promote Privacy and Cybersecurity in Modern Healthcare Organizations
Jaime S. Pego is a Director in the Short Hills, New Jersey, office of KPMG LLP’s Healthcare Advisory Services Practice and serves as the firm’s National HIPAA Privacy Director. She has substantial experience in healthcare regulatory compliance and healthcare-related advisory services.
Ms. Pego works with a variety of healthcare clients to assist with identifying and preventing compliance risks and complying with federal and state regulations. Her work for KPMG includes serving as lead director for OCR HIPAA audits, as well as acting as Privacy Lead for the KPMG HIPAA national service line assisting covered entities and business associates with HIPAA compliance. She has conducted internal investigations concerning a variety of topics, including fraud and abuse, HIPAA violations, as well as other legal and regulatory matters, and researched and developed compliance policies for institutions in the areas of gifting under the Anti-Kickback Statute and Stark Law, the DRA, HIPAA, EMTALA and others. She participates in the KMPG National HIPAA working group to develop tools and methodologies for client needs, and conducts and manages ICD-10 Impact Assessment at a variety of healthcare organizations to help identify gaps in ICD-10 readiness. She has also served as the firm’s lead manager for health care reform legislative analysis and research.
Prior to coming to KPMG, Ms. Pego was a Local Compliance Officer at a teaching hospital and outpatient center for one of New Jersey’s largest health care systems and has worked with some of the country’s leading health systems. She received her BA from American University and her JD from Seton Hall University School of Law, with a Concentration in Health Law, and is Certified in Healthcare Compliance (CHC) by the Health Care Compliance Association (HCCA).
Joy Pritts, Chief Privacy Officer, ONC, HHS, Meaningful Use Regulations: What Providers Need To Know To Comply
Joy Pritts joined the Office of the National Coordinator for Health Information Technology (ONC), Department of Health & Human Services in February 2010 as its first Chief Privacy Officer. Ms. Pritts provides critical advice to the Secretary and the National Coordinator in developing and implementing ONC’s privacy and security programs under HITECH. She works closely with the Office for Civil Rights and other operating divisions of HHS, as well as with other government agencies to help ensure a coordinated approach to key privacy and security issues.
Prior to joining ONC, Ms. Pritts held a joint appointment as a Senior Scholar with the O’Neill Institute for National and Global Health Law and as a Research Associate Professor with the Health Policy Institute, Georgetown University. She has an extensive background in confidentiality laws including the HIPAA Privacy Rule, federal alcohol and substance abuse treatment confidentiality laws, the Common Rule governing federally funded research, and state health information privacy laws.
Ms. Pritts received her BA from Oberlin College and her JD from Case Western Reserve University.
Anna Spencer, Esq., Sidley Austin, LLP, Data Breaches/Data Breach Notification Requirements and the Need for Encryption
Anna Spencer is a partner in Sidley Austin’s Washington, D.C. office whose practice focuses on health care. Ms. Spencer primarily works on matters involving the privacy and security of health information and she is the firm’s global coordinator for health information privacy. She regularly counsels a broad range of clients on healthcare information privacy and security issues. This includes assisting clients with respect to HIPAA and HITECH and has significant experience in investigating and responding to data breaches and information security incidents. She has represented clients in connection with data breach reporting obligations under the HITECH regulations for breaches of protected health information and defended health care providers in investigations initiated by the Office of Civil Rights, Department of Health and Human Services.
On behalf of covered entities and entities that qualify as HIPAA business associates, Ms. Spencer has developed multiple HIPAA privacy and security compliance and training programs. She has negotiated hundreds of Business Associate Agreements on behalf of various clients.
Ms. Spencer has spoken on privacy/security matters on behalf of numerous groups such as BNA and the American Conference Institute. She has authored a variety of articles on privacy/security issues, Medicare coverage, and fraud and abuse. She is currently authoring a book for BNA on health information privacy. Ms. Spencer received her BA from Sewanee and her JD from Vanderbilt University School of Law.
Mark Swearingen, Esq., Hall, Render, Killian, Heath & Lyman, PC, HIPAA and HITECH Trends (Enforcement and Otherwise)
Mark Swearingen coordinates the HIPAA practice and provides counsel on health information privacy and security matters such as breach response and notification and the creation, use, disclosure, retention and destruction of medical records and other health information at the Indianapolis law firm, Hall, Render, Killian, Heath & Lyman, P.C. His counsel to clients also includes a variety of health care topics related to regulatory compliance, physician and clinical services contracting, risk management and Independent Review Organization services. He has provided such services to a broad spectrum of health system, hospital, physician practice, diagnostic imaging center, ambulatory surgical center and long-term care facility clients.
Mr. Swearingen has spoken and written nationally and regionally on numerous topics, including antitrust, electronic medical records and health information privacy and confidentiality. He is an adjunct professor of a course in Law and Medicine at the Indiana University School of Informatics at IUPUI.
Mr. Swearingen received his BA from Indiana University and his JD from Seton Hall Law School.
Seton Hall Professor and Health Care Regulation Expert Frank Pasquale to Present Draft White Paper Outlining Options and then Moderate a Discussion on its Pros and Cons with Fellow Academics
Washington, D.C. – Seton Hall University School of Law hosted an academic roundtable discussion on how our current healthcare law will respond to the new technology environment – in particular, maintaining privacy for consumers as the health industry expands adoption of cloud computing, on Friday, March 22, 2013. Seton Hall Professor Frank Pasquale moderated the event, “The Future of HIPAA and The Cloud,” and also released a white paper he coauthored with Tara Adams Ragone on the challenges that cloud computing technologies pose to the Health Insurance Portability and Accountability Act (HIPAA).
As the recent HIPAA Omnibus Rule showed, regulation must both reflect and shape technological advances. As stakeholders face new challenges and opportunities, the roundtable asked: What is the future of HIPAA in the cloud? How will patient data be used? What is the role for third party vendors? And who should be held responsible for security breaches in the cloud?
White paper abstract:
This white paper examines how cloud computing generates new privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare entities. Nevertheless, more needs to be done to assure that health privacy and all the values it is meant to protect are actually vindicated in an era of ever faster and more pervasive data transfer and analysis.
After describing how cloud computing is now used in healthcare, this white paper examines nascent and emerging cloud applications. Current regulation addresses many of these scenarios, but also leaves some important decision points ahead. Business associate agreements between cloud service providers and covered entities will need to address new risks. To meaningfully consent to new uses of protected health information, patients will need access to more sophisticated and granular methods of monitoring data collection, analysis, and use. Policymakers should be concerned not only about medical records, but also about medical reputations used to deny opportunities. In order to implement these and other recommendations, more funding for technical assistance for health privacy regulators is essential.
I have hinted at problems with uniform trade secrecy laws in this volume and a law review article. I plan to continue that line of research in a co-authored work with Dave Levine, exploring the costs of trade secrecy in the finance, energy, and communications sectors. When it comes to “solutions,” I’m increasingly inclined to frame the issue as: how do we operationalize the insights of Michael Carroll’s “Uniformity Costs” concept? In other words, how do we shape doctrine so that it respects the unique economic conditions (and moral imperatives) related to specific industries?
One way to do so is to insist on the autonomy of a subject matter defined legal field (versus the trans-substantive aspirations of, say, contract, property, or intellectual property law). The “law of the horse crowd” usually assails that autonomy by warning about the distortionary affects of applying different laws to different sectors. Health law professors shared that worry for a while, debating whether health care law is a “coherent field.” But that anxiety seems to have faded as a distinct arena of health care economics develops and lawyers set to work implementing the massive HITECH and PPACA legislation passed in 2009 and 2010. The stage is now set for a distinctive law of “health information” to emerge, as third party payers and government use their leverage in the sector to tamp down counterproductive IP- and contract-based corporate strategies.
The law of health information is neither more “open” nor more “closed” than information law generally. Free access should be dictated in areas of extreme personal or societal need; in other cases, it may be right to force high payments, either ex ante via taxes, or ex post via high prices, from those with the ability to pay. Privacy should play a far more important role here than it does in the usual Wild West of internet data collection and processing. But once data is truly anonymized, the research imperative for access is perhaps more pressing than in any other area of law (except, perhaps, national security.).
For a recent controversy where laws of copyright seem inappropriate in a medical setting, check out this story:
According to the New England Journal of Medicine, after thirty years of silence, authors of a standard clinical psychiatric bedside test have issued take down orders of new medical research. Doctors who use copies of the bedside test which will have been printed in some of their oldest medical textbooks are liable to be sued for up to $150,000. . . . [E]ven the ghosts of positively ancient abandoned copyrights for the very simplest of ideas can be used to block new medical work through legal bullying.
The “thirty years” of silence part makes me want to look into a laches claim. The simplicity of the test also seems to invite a merger defense. On the other hand, perhaps the best answer is compulsory licensing, which should have gotten more attention during the SOPA/PIPA flap. Whatever solution is optimal, the implication of the NEJM piece is clear: health professionals believe their field deserves some autonomy from the normal laws of intellectual property. Popular reaction against secret prices of medical devices and hospital procedures also reflects that view.
In many areas, such rebellions against pricing the priceless have translated into general skepticism about intellectual property. In health care, they may lead to something different: a health information law distinct from the IP and privacy laws of general application.
An eminence grise of cyberlaw once told me that he got into the field in the 1980s because it was one of the few areas where things were “up for grabs” enough that a creative scholar could still have an influence. An elder statesman of the IP field told me that it had gone into “normal science” mode as of 2004 or so. Perhaps those who still want “paradigm shifts” need to work heavily regulated fields like health information law, where government policymakers are more regulators for (rather than instruments of) vendors and providers.
Health information law is a very exciting field. Lawyers, doctors, and start-ups are re-thinking health care as an information industry. I’ll be speaking on privacy and fair data practices at an upcoming conference. The relationships between privacy, “big data,” and trade secrecy will bear a great deal of attention in coming years.
Software-based automation has raised living standards dramatically. It makes factories more efficient, renders vast amounts of information accessible, and daily improves quality of life in barely noticed ways. To realize these types of advances in health care, government and NGOs have begun to catalyze better data collection, retention, and analysis. Life sciences companies need to report more data on drugs and devices. Hospitals and doctors are incentivized to use electronic health records via stimulus funding and rulemaking based on the HITECH Act’s meaningful use and certification requirements.
How will traditional intellectual property laws interact with these initiatives? Will the increasing need for cooperation and sharing of information alter the landscape of trade secrecy and other IP protections that have often siloed health data? Will providers find alternative funding sources for the collection, retention, and analysis of data, as some traditional IP protections appear increasingly outdated in a world of “big data” and market-driven transparency?
Medical privacy law has focused on assuring the privacy, security, and accuracy of medical data. The post-ACA landscape will include more concern about balancing privacy, innovation, access, and cost-control. Advanced information technology has raised a number of new questions. Beyond HIPAA and HITECH regulation, consumer protection law plays an important role in these fields. (For example, the FTC recently required firms that “score” the health status of individuals based on their pharmacy records to disclose these records to scored individuals.)
Patients are opting to personalize their health records with the help of cloud computing firms; what law governs this digital migration? There is increasing concern about the role of “incidental findings” in medical research and practice; how will regulators and professional groups address them? When employers demand access to employee health records, in what ways can they use them to profile the employee?
We also need to examine the legal aspects of data portability, integrity, and accuracy. When two health records conflict, which takes priority? What is “meaningful use” of an electronic health records system, and how will regulators and vendors assure interoperability between systems? The course will also cover innovators’ efforts to protect their health data systems using contracts, technology, trade secrecy, patents, and copyright, and “improvers’” efforts to circumvent those legal and technological barriers to openness.
Finally, what are pharmaceutical companies’ past and present strategies regarding the disclosure of their research, including non-publication of adverse results and ghostwriting of positive outcomes? Will a “reproducible research” movement, popular in the hard sciences, reach pharmaceutical firms? Insurer data will also be a target of reformers (including trade-secret protection of prices paid to hospitals, conflicts over the interpretation of disclosure requirements in the ACA, and state regulation of insurer-run doctor-rating sites). Quality improvement and pilot programs will need good provider and insurer data–how we will ensure they have them?
[Ed. Note: We are pleased to welcome Ana Liggio, Esq., to HRW. She is a health care and technology lawyer, in practice over 15 years. Prior to pursuing her LL.M. in Health Law here at Seton Hall Law, she was Director, Law Department, for Sony Electronics.]
The CMS website explains that meaningful use “means providers need to show they’re using certified EHR technology in ways that can be measured significantly in quality and in quantity. As CMS moves into finalizing meaningful use, Stage 2 requirements, I would like to introduce the concept of “meaningful experience” as an essential corollary to that of “meaningful use.”
Meaningful experience takes the idea a step further, representing ways to evaluate and encourage the merits of both proposed and existing criteria as seen from the value they bring to the provider and healthcare consumer stakeholders. While “meaningful use” focuses on ensuring that the financial beneficiaries of the Medicare and Medicaid EHR Incentive Program (the “Program”), the Certified Electronic Health Record Technology (“CEHRT”) industry, and the eligible healthcare providers (insofar as meaningful use bonus payments are at stake), continue to operate their EHR in a purposeful manner, there are additional, important stakeholders to consider. With billions of federal and state dollars earmarked for the Program and a strong interest in seeing EHR enjoy long-term success, taking a broader view of stakeholders and inserting more transparency into their experiences will better help the Program thrive. Meaningful Use, Stage 2, is the perfect time to look towards ensuring meaningful experience.
The Program is in full swing, with the Centers for Medicare and Medicaid Services (“CMS”) having released the NPRM on Meaningful Use, Stage 2, in the Federal Register on March 7, 2012.
The CMS blog explains: “Today’s proposed rules focus on using EHRs to improve health and health care while reducing the burden on physicians and hospitals where possible.” With early participation rates appearing strong, CMS continues to be cautious about keeping industry groups engaged and seeking out robust commentary through the NPRM. CMS clearly wants the healthcare industry to continue up the “EHR Escalator” without having anyone jump off for being frustrated or overwhelmed. To date, the strategy is working, as the CEHRT industry and healthcare providers appear to be embracing the Program. However, as Nicolas Terry points out in his article “Anticipating Stage Two: Assessing the Development of Meaningful Use and EMR Deployment,” ultimately, growth will have to be endogenous, fueled by innovation and consumer demand.
The comprehensive NPRM for Meaningful Use, Stage 2 demonstrates CMS’s commitment to considering the experiences and opinions of the interested industries. The ONC also asks data holders and non-data holders to take a pledge “to empower individuals to be partners in their health through health IT.” There is no doubt that the Program is making huge strides and continuing to chip away at the difficult issues of interoperability, access, privacy and security- and pushing the United States slowly but surely closer to a much higher healthcare IT standard similar to that enjoyed by many other developed nations. Moving into Stage 2, CMS seeks to enhance interoperability among different entities and further patient involvement by requiring increased access to their health information. That being said, the ONC’s National Coordinator for Health Information Technology, Farzeed Mostashari, explains that Stage 2 is meant to be more “evolutionary than revolutionary.” Importantly, Stage 2 also begins an initiative to align the requirements of the Program with other complementary, ongoing healthcare reform initiatives involving national quality and the development of ACOs.
Reading through the NPRM, I saw a few areas that CMS could focus on to help build a self-sustaining system. First, the initial iteration of the Program was clearly written with an eye toward maximizing meaningful use for family care and general practitioners and not towards other types of practices like pediatrics, various specialists, and physicians whose practices do not entail much face-to-face patient interaction (e.g., radiologists); they should be given further attention. Second, while CMS provides somewhat of a return on investment analysis in the NPRM, it apologetically declares it too early in the Program to be able to provide meaningful data; CMS could use the attestation process to collect the necessary data. Finally, healthcare consumers – those taxpayers who fund this program — should be actively considered and made aware of the enhancements and improvements that comprise the Program, which will be offering them a more efficient, accessible, safe and evidence-based healthcare experience; a “meaningful user” designation for CEHRT users who meet certain criteria could be developed to help providers publicize their investment in the Program and the attendant benefits it will bring to their patients. Meaningful Use, Stage 2, is the perfect time to address these issues and move the Program forward in such a way that will make it self-sustaining for the long-term, not because of incentive funding, but because meaningful use is providing a meaningful experience to the various EHR stakeholders.
As with early versions of the Medicare Shared Savings Plan and healthcare reform generally, the focus of the Program’s meaningful use objectives and criteria, initially at least, is on general practitioners and how they can use EHR to advance the overall wellbeing of the population. This goal is laudable, of course, but the population of eligible providers extends well beyond PCPs. Certain objectives and measures allow providers to claim an exclusion if they do not apply to their practice, thereby not penalizing those types of practitioners for whom compliance would be unnecessary and inefficient. However, focus on these different categories of practices could allow for alternative objectives and measures to be found. If one were to consider meaningful experience in addition to meaningful use, the attestation would ask EPs who are claiming exemptions to use and, possibly attest to, alternative meaningful use standards that are applicable to their practices. For instance, there is a proposed measure for recording 80% of an EP’s patients’ height, weight and blood pressure as structured data. There is an available exclusion, however, for EPs who do not believe that recording such vital signs is “relevant to their scope of practice.” An EP who claims the exclusion simply gets a pass on this field during the attestation process. Alternatively, a required (or even optional) free-form response area could be provided in the attestation each time an EP claims exclusions. As time goes on, data would be collected that would allow CMS to customize attestations, and CEHRT requirements as well, to different specialties so that meaningful use translates into meaningful experience for those whose practices do not fit the general practitioner mold on which the first versions of Meaningful Use were based. Certainly the technology will allow, rather easily, for modifications where appropriate if the effort is set forth to ask those in the field what would be meaningful to their practices and to encourage them to use the EHR tools available to them in such ways.
Because the proposed rule is anticipated to have an annual effect of over $100 million on the economy, a Regulatory Impact Analysis (RIA) that measures costs and benefits must be performed. While CMS does a fair job of estimating costs to providers of implementing EHR and costs to taxpayers of funding the Program, it has not done much to quantify benefits gleaned. The NPRM qualifies its analysis by pointing to various unknowns and a lack of “new data regarding rates of adoption or costs of implementation.” Without specific data, it estimates various “high and low” scenarios for different practice settings and ultimately concludes, “there are many positive effects of adopting EHR” as well as various benefits for society. While I tend to agree with this conclusion as general matter of conjecture, why not collect the actual data during the attestation process? Ask the EHR attesters how much their systems cost initially and to maintain. Ask the EHR attesters where the systems are adding value to their practices and for their patients. Yes, it’s a leap of faith to ask these questions because the answers may not offer a perfect picture, but they will offer an honest representation of the current state that can be addressed going forward. It is only fair to give the stakeholders an honest assessment and it would not be difficult to collect the data. While EHR is all about collecting healthcare data and crunching numbers to see trends and identify areas where improvements can be made, let’s use those same principals here to perform the same analysis with regard to the EHR technology.
Finally, to assist providers who have made the investment and will continue to feed important data to the various government health databases, CMS could offer some type of certification that the providers could use in marketing their practices. For all the good that EHR is meant to do in terms of patient safety, efficiency of care and meaningful communication between patients and their providers, let’s devise a way to inform patients about which providers are running state-of-the-art practices. Providers who attest to meeting the meaningful use requirements could be offered the option of using a certified meaningful user designation and displaying a certain logo, all of which would indicate to the public that such providers are using the latest healthcare technology. For healthcare consumers who consider it important to have the ability to access their records or have their prescriptions transmitted electronically, for example, this designation would help lead them to the types of practices they desire. Assuming this is the future of healthcare and what the American public desires or will come to desire of its healthcare providers, such a tool would be useful to the providers and healthcare consumers alike.
At the end of the day, the success of the EHR program, and the value it will have brought to the US healthcare system, will be measured by the experience of the healthcare providers and consumers. In the best-case scenario, there will be data showing that the EHR Program has achieved the desired results with a minimum burden placed upon providers. But what will actually entice providers to continue to make “meaningful use” of the systems will be when meaningful use results in an experience they deem worthwhile for themselves and their healthcare consumers and when their patients agree. As such, CMS should use the attestation process and resultant data to continuously measure the actual costs and benefits and make adjustments as needed. During the attestation process, it could ask providers to suggest alternative meaningful uses for EHR when the existing measures do not apply and to volunteer cost data and their impressions of meaningfulness. Finally, CMS could give providers a way to publicize their commitment to using technology to enhance patient care. Some time and effort devoted to meaningful experience will allow meaningful use to translate into a self-sustaining, successful program.
[Ed. note: this piece originally ran on April 17, 2012, but was lost in the vagaries of cyberspace to a blog mishap. It's just too good to lose and so here enjoys a repeat performance]