The global health and life sciences market is large, complex and fragmented. While data flows freely, an information gap has formed. Pfizer has made investments in companies like Private Access, Keas and Acacia Living that focus on personalized healthcare, health and wellness, and empowering consumers. Pfizer also looks to form partnerships to solve complex problems through multi-stakeholder collaboration.
How to Create a Big Data Culture in PharmaChris Waller
A talk presented at the Big Data and Analytics conference in Boston on January 28, 2014. Emphasis on data and information sharing cultures in companies.
How to Create a Big Data Culture in PharmaChris Waller
A talk presented at the Big Data and Analytics conference in Boston on January 28, 2014. Emphasis on data and information sharing cultures in companies.
A unified platform providing functionality based on role is a logical progression in eClinical technology development, with the majority of sponsors/CROs preferring and supporting this evolution.
Integrate RWE into clinical developmentIMSHealthRWES
With greater application of RWE throughout the pharmaceutical
lifecycle, learnings are emerging that offer guidance for
approaches to derive the maximum value. This article captures
the author’s experience at a leading international biotech, with
insights for smoothing RWE assimilation into clinical
development and realizing the benefits it brings.
Strand featured in CIO Review: Pharma and Life Science Special edition - July 2014
Strand Genomics Inc recognised by CIO Review as one among 20 most promising Tech solution providers to Pharma and Life science industry 2014
2014 Overview of significant trends in the life sciences (Biotechnology, Pharmaceutical, Device and Diagnostics) industry with Big Data in the Life Sciences featured articles.
In the world of pharma precompetitive efforts are increasing. These developments have created a dynamic ecosystem with pharma as smaller nodes in a complex network, in which collaborations have become an important business model.
Big data, RWE and AI in Clinical Trials made simpleHadas Jacoby
Technology is slowly but surely penetrating the healthcare industry in general and the clinical trials sector in particular. New and advanced solutions offer a variety of possibilities aimed to both improving existing processes and creating new and more efficient ones. And on top of all stands the desire to make clinical trials more patient centric.
In all of this, even though some of the technologies have yet to mature enough to meet the high quality standards necessary, it is important to know them and begin imagining the promise they hold for clinical trials.
Crossroads: U.S. Medical Device Regulation vs. Innovation
The U.S. medical device industry is at a regulatory and potentially economic crossroad as the FDA continues to refine its 510(k) regulatory submission requirements and guidelines. Medical device manufacturers have been urging the FDA and Congress to expedite new product review processes to spur innovation and bring new medical technologies to market faster. However, supporters of stricter FDA regulations claim that a faster regulatory review process causes unsafe devices to enter the market.
As a result of numerous exchanges between both sides of the issue, CDRH (FDA) recently issued multiple updates to its initiatives for the 510(k) approval process. To shed light on key changes, we obtained the support of the office of Dr. Jeffrey Shuren MD JD, Director of CDRH and Dr. John Smith MD JD, of Hogan Lovells, a prominent international law firm with a medical regulatory specialty, on their interpretations of the 510(k) regulatory guidelines and the impact these guidelines will have on medical device manufacturers.
Listen to the Dr. John Smith podcast interview here:
http://youtu.be/iHVpwwXi7dY
The MarkeTech Group
502 Mace Blvd.
Davis, CA 95618
http://www.themarketechgroup.com
Oncology Intelligence 2014 Report (Second Updated Edition)
Report to Cover all Aspects of Cancer Drug Development Intelligence
COMPANIES * MOLECULES * INDICATIONS * TECHNOLOGIES * DEALS * FUNDING
Oncology Drug Report 2014 –World’s Largest Active Resource for Decision Making, is designed to curtail down the efforts in identifying the real picture of present cancer drug development market, by bringing more authentic data under review and eliminating the undesired information.
For Details Visit :- https://omicsx.com/reports/cancer/oncology-intelligence-report-2014/
21st Century Act and its Impact on Healthcare ITCitiusTech
This document gives an overview, core objectives of the act and enumerates purpose of each part / division of the 21st Century Act. It lists down the sections of the act which have a direct impact on Healthcare IT and gives a brief overview of each section.This document also explains the impact of 21st Century Cures Act on regulatory bodies: FDA / NIH / HSS.
A unified platform providing functionality based on role is a logical progression in eClinical technology development, with the majority of sponsors/CROs preferring and supporting this evolution.
Integrate RWE into clinical developmentIMSHealthRWES
With greater application of RWE throughout the pharmaceutical
lifecycle, learnings are emerging that offer guidance for
approaches to derive the maximum value. This article captures
the author’s experience at a leading international biotech, with
insights for smoothing RWE assimilation into clinical
development and realizing the benefits it brings.
Strand featured in CIO Review: Pharma and Life Science Special edition - July 2014
Strand Genomics Inc recognised by CIO Review as one among 20 most promising Tech solution providers to Pharma and Life science industry 2014
2014 Overview of significant trends in the life sciences (Biotechnology, Pharmaceutical, Device and Diagnostics) industry with Big Data in the Life Sciences featured articles.
In the world of pharma precompetitive efforts are increasing. These developments have created a dynamic ecosystem with pharma as smaller nodes in a complex network, in which collaborations have become an important business model.
Big data, RWE and AI in Clinical Trials made simpleHadas Jacoby
Technology is slowly but surely penetrating the healthcare industry in general and the clinical trials sector in particular. New and advanced solutions offer a variety of possibilities aimed to both improving existing processes and creating new and more efficient ones. And on top of all stands the desire to make clinical trials more patient centric.
In all of this, even though some of the technologies have yet to mature enough to meet the high quality standards necessary, it is important to know them and begin imagining the promise they hold for clinical trials.
Crossroads: U.S. Medical Device Regulation vs. Innovation
The U.S. medical device industry is at a regulatory and potentially economic crossroad as the FDA continues to refine its 510(k) regulatory submission requirements and guidelines. Medical device manufacturers have been urging the FDA and Congress to expedite new product review processes to spur innovation and bring new medical technologies to market faster. However, supporters of stricter FDA regulations claim that a faster regulatory review process causes unsafe devices to enter the market.
As a result of numerous exchanges between both sides of the issue, CDRH (FDA) recently issued multiple updates to its initiatives for the 510(k) approval process. To shed light on key changes, we obtained the support of the office of Dr. Jeffrey Shuren MD JD, Director of CDRH and Dr. John Smith MD JD, of Hogan Lovells, a prominent international law firm with a medical regulatory specialty, on their interpretations of the 510(k) regulatory guidelines and the impact these guidelines will have on medical device manufacturers.
Listen to the Dr. John Smith podcast interview here:
http://youtu.be/iHVpwwXi7dY
The MarkeTech Group
502 Mace Blvd.
Davis, CA 95618
http://www.themarketechgroup.com
Oncology Intelligence 2014 Report (Second Updated Edition)
Report to Cover all Aspects of Cancer Drug Development Intelligence
COMPANIES * MOLECULES * INDICATIONS * TECHNOLOGIES * DEALS * FUNDING
Oncology Drug Report 2014 –World’s Largest Active Resource for Decision Making, is designed to curtail down the efforts in identifying the real picture of present cancer drug development market, by bringing more authentic data under review and eliminating the undesired information.
For Details Visit :- https://omicsx.com/reports/cancer/oncology-intelligence-report-2014/
21st Century Act and its Impact on Healthcare ITCitiusTech
This document gives an overview, core objectives of the act and enumerates purpose of each part / division of the 21st Century Act. It lists down the sections of the act which have a direct impact on Healthcare IT and gives a brief overview of each section.This document also explains the impact of 21st Century Cures Act on regulatory bodies: FDA / NIH / HSS.
Quality Improvement Strategies: quality improvement tools, factors that help to create and sustain Healthcare Informatics as a new field. quality improvement cycle: PDCA (Plan, Do, Check, Act) Cycle.
Denis Cortese, M.D., president and CEO of Mayo Clinic, and Mayo Clinic Rochester chief administrative officer Jeff Korsmo presented highlights of the Mayo Clinic Health Policy Center's work on health care reform.
Healthcare data and its impact upon the patient care decision process via accurate, real-time, reliable data from disparate sources is creating a digital health revolution. Data-driven healthcare is beginning to have a huge impact addressing the challenges of every provider, through efficient handling of huge volumes of patient care data.
Providers need to move towards real-time analytics that have become critical to demonstrate their quality of care, as reimbursement by government programs can be contingent upon how providers are measured in “Quality of Care”. For example, the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, also called the Permanent Doc Fix, changes the way Medicare doctors are reimbursed with the implementation of a merit based incentive. The performance-based pressure is huge, which makes it imperative that every provider consider technology solutions. Read more at https://www.solix.com/solutions/data-driven-solutions/healthcare/
Payers are being challenged as the industry shifts from volume-based care to a value-based reimbursement structure that would benefit the patient, the healthcare provider and the payer. New payment models including fee-for-service only and pay-for performance creates impetus for payers to acquire, aggregate, and analyze data.
Electronic health record (EHR) is a computerized patient-centric history of an individual’s health
care record that includes data from the multiple sources of care that the patient has used.
The convergence of separate health systems has led to
a great increase in data, which some organisations are
struggling to get to grips with. Harnessing analytic tools
and sharing knowledge is the best way forward
Assignment 1 Legal Aspects of U.S. Health Care System Administrat.docxbraycarissa250
Assignment 1: Legal Aspects of U.S. Health Care System Administration
Due Week 3 and worth 200 points
Prevailing wisdom reinforces the fact that working in U.S. health care administration in the 21st Century requires knowledge of the various aspects of health laws as they apply to dealing with medical professionals. Further, because U.S. health care administrators must potentially interact with many levels of professionals beyond the medical profession, it is prudent that they be aware of any federal, state, and local laws that may be applicable to their organizations. Thus, their conduct is also subject to the letter of the law. They must evaluate the quality of their professional interactions and be mindful of the implications and ramifications of their decisions.
Nearly 65 million surgical operations were performed in 2015 in the U.S. resulting in an estimated 200,000 deaths from complications or other post-operative issues (Ghaferi, Myers, Sutcliffe, & Pronovost, 2016). Ongoing innovation in healthcare can improve patient outcomes. According to the Harvard Business Review article, The Next Wave of Hospital Innovation to Make Patients Safer, over the past several decades, there have been three distinct waves of surgical improvement: technical advancements, standardizing procedures, and high reliability organizing.
Assume the role of a top health administrator at We Care Hospital. You are interested in propelling the hospital to the next level by applying for the Malcolm Baldrige National Quality Award. However, you want to ensure surgical outcomes for patient morbidity and mortality rates. You begin by researching the Surgical Care Improvement Project (SCIP) aimed to improve adherence to quality protocols. You need to ensure the hospital policy is consistent with the law and that the hospital is correctly reporting Sentinel Events to the Joint Commission, a hospital regulatory agency.
Note: You may create and / or make all necessary assumptions needed for the completion of this assignment.
Write a three to four (3-4) page paper in which you:
1. Analyze how standardizing procedures and documenting steps can improve outcomes when performing a complex procedure. Review the peer-reviewed journal article, The Next Wave of Hospital Innovation to Make Patients Safer. Articulate your position as the top administrator concerned about the importance of professional conduct and negligence in SCIP quality guidelines.
2. High Reliability Organizing emphasizes the varying actions that can affect patient safety given that standardized systems ignore the fact that each patient is different. Ascertain the major ramifications when the health care team “fails to rescue” the patient. Identify what hospital policies should be in place and identify previous case laws.
3. Analyze the four (4) elements required of a plaintiff to prove medical negligence.
4. Discuss the overarching duties of the health care governing board in mitigating the effects of medical non- ...
Part of the "2016 Annual Conference: Big Data, Health Law, and Bioethics" held at Harvard Law School on May 6, 2016.
This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S.
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.
Learn more at http://petrieflom.law.harvard.edu/events/details/2016-annual-conference.
2. The global health and life sciences market is a large, complex and highly fragmented. While “data” is flowing freely through the system unabated, an “information” gap has formed. Providers Payers Regulators Policy Makers Accreditation Entities Govt. Programs Diagnostic Services/ GCRCs Employers Regulations Applications and Approvals Licenses Licensed Health Prof’nals Consumers/ Patients $ Coverage Health Plans/ Care Premium $ Health Delivery Systems/ Facilities $ $ $ Carve Outs (PBMs, others) “orders” Products Pharmacies Pharma. (including Biotech) Medical Products Contract Services Nursing and Home Health Global Insurers Distributors Info Companies Generic Mfgs. Products The Worldwide Healthcare Ecosystem
3. What is Happening in HIT: Growing HIT Momentum in the US Selected Critical Developments Projected Timeline 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 MMA mandates federal eRx standards by 2009 Healthcare Reform Enacted. $35B alloc. to HIT Pressure to Accelerate June 2005 AHIC & RFPs Announced Pressure to Accelerate Mar 2001 Landmark IOM study “Crossing the Quality Chasm” identifies rampant errors and urges HIT Dec 2003 MMA becomes law. Pfizer leads successful effort to block federal eRx mandate, but timetable is set to drive eRx standards process Jul 2004ONCHIT releases strategic framework for NHII ARRA: majority of Americans use EMRs by 2015 Kerry Pledge: 100% EHR use by 2008 Pressure to Accelerate June 2004 RAND study estimates that Americans receive only 55% of recommended care and proposes HIT- based solutions Apr 2004 Presidential Executive Order sets EHR adoption goal, and appoints Dr. David Brailer to lead the Office of the National HIT Coordinator (ONCHIT) Note: ONCHIT = Office of the National Health Information Technology Coordinator NHII = National Health Information Infrastructure MMA = Medicare Modernization Act
4. HITECH The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009, was signed into law on February 17, 2009, to promote the adoption and meaningful use of health information technology. DIVISION A: TITLE XIII—HEALTH INFORMATION TECHNOLOGY Subtitle A—Promotion of Health Information Technology PART 1—IMPROVING HEALTH CARE QUALITY, SAFETY, AND EFFICIENCY PART 2—Application and use of adopted health information technology standards; Reports Subtitle B—Testing of Health Information Technology Subtitle C—Grants and Loans Funding Subtitle D—Privacy PART 1—IMPROVED PRIVACY PROVISIONS AND SECURITY PROVISIONS PART 2—RELATIONSHIP TO OTHER LAWS; REGULATORY REFERENCES; EFFECTIVE DATE; REPORTS DIVISION B: TITLE IV—MEDICARE AND MEDICAID HEALTH INFORMATION TECHNOLOGY; MISCELLANEOUS MEDICARE PROVISIONS Subtitle A—Medicare Incentives Subtitle B—Medicaid Incentives Subtitle C—Miscellaneous Medicare Provisions
5. eHealth at Pfizer (2010) We developed a capability called eHealth, which is a group that focuses on thinking about the convergence of healthcare and information technology. Over the last nine months, we’ve made three investments in companies that are in the e-Health space: Private Access, Keas, and Acacia Living. All three are focused on driving consumer outcomes-based healthcare. They’re in the vein of personalizing medical treatment, health and wellness; and they’re in the vein of decentralizing health and wellness so that consumers are more responsible and more engaged, as well as their communities and caregivers. Another capability is looking at complex partnerships between large players effecting healthcare to solve very complex problems requiring multi-player solutions. So, we’ve been building the capability to think about multiple-player collaboration and business models. One of the investments that we made in the last nine months is Private Access. It is enabling a collaborative model, which addresses clinical trial improvement through building an eco-system across the industry, bringing multiple stakeholders, government, private sector, and society together in a coherent and consolidated way. From an interview with Usama Malik. http://www.innovate1st.com/newsletter/october%202010/TheInnovators.html
6. eHealth Steering Committee WWS&I WWBD WW BT WW Policy Technology Strategy Strategy Setting Search & Evaluation US Policy Strategy Technology Standards Program Management Due Diligence US Advocacy Technology Evaluation Business Architecture Deal Negotiation Intl. Policy Strategy Technology Architecture Alliance Management Investment Management Intl. Advocacy Technology Delivery
7. eHealth: Convergence of Healthcare and Technology Patient-centric Provider-centric Care provision augmentation Health & Wellness Consumer Electronics Business Diversification beyond Pharma New Product and Services Health & Wellness Self-Management Services Clinical Decision Support Aids Uses of Clinical Data for R&D Adverse Event Reporting Utility Health Economics Analytics Business Innovation within Pharma Clinical Data Flow and Uses 7
30. Demonstrate value of program to other employers to support reimbursementiPhone Our Goal: - Demonstrate Behavior Modification - Improved Medication Adherence, Persistence, and Quit Rates
33. Summary of Pfizer’s HIT Efforts Support and Transform Medical Practice Adverse Drug Event Spontaneous Electronic Reporting (ASTER) 217 reports in 5 mons. vs. 0 (25% “serious”) 7x as much (structured) data as normal report Support Patient-Centric Healthcare Keas Text4Baby Nutrition, flu prevention, immunization, etc. Free, 100,000 subscribers G.C. Simon, AJMC-2010-08-0217
34. Summary of Pfizer’s HIT Efforts Improve Clinical Trials Private Access PACeR Clinical Trial Atlas Partnership with National Minority Quality Forum to collect and map trial data to demographics Expedite Research Connecting for Drug Safety Collaboration of the eHealthInitative Safety Surveillance in electronic healthcare data Observational Medical Outcomes Partnership (OMOP) 2 year pilot to develop methods to query databases to assess safety of drugs on market G.C. Simon, AJMC-2010-08-0217
35. Recommendations Embrace and Fully Fund Public-Private Partnerships Development of a National Clinical Trials Infrastructure Development of Systems that Provide Selective Sharing of Electronic Health Data Development of HIT Platforms that Allow Physicians Access to All Approved Options to Inform Decisions for Patients’ Health Implement an Incentive Model that Encourages Sustained Investment in HIT G.C. Simon, AJMC-2010-08-0217
36. eHealth at Pfizer (2011) Connected Health Contact Usama Malik for more information