CE and FDA Certification
ST-NET and the STDM software has received the CE certification as medical device. The software increases the efficacy and safety of Scrambler Therapy, and is therefore considered as an integrating part for the correct usage of the medical device itself and its best clinical practice. For this reason the software certification is that of a medical device.
FDA still does not foresee any specific certification for this type of software (Not Classified).
Health Insurance Portability And Accountability Act (HIPAA) and Safe Harbor Compliance
Scrambler Therapy is a therapy that does not require medical device parameter setting, but its operator-dependent feature is of critical importance. This feature is based on correct methodology implementation and full compliance to protocol guidelines.
ST-NET is fully compliant to HIPAA and Safe Harbor privacy standards. Implemented multi-level protection requirements are higher than those in most popular commercial software. HIPPA acknowledges the Safe Harbor method as complaint to privacy protection. Currently there is no official body to certify compliance to HIPPA, but HIPPA acknowledges the Safe Harbor method as complaint to privacy protection (http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html ). STDM uses simultaneously the two de-identification methods envisaged by HIPAA (Expert Determination method and “Safe Harbor” method).
In the beginning, when Scrambler Therapy's scientific innovation was first introduced in the chronic pain area, a lot of attention from the scientific and medical community was focused on possible placebo effect in trying to explain results the seemed “incredible”. This selective focus together, with poor knowledge about theory principles and correct usage methodology, completely different from any other type of electro-analgesia, has determined a neglect of other variables that are statistically much more meaningful in their impact on treatment results than placebo. More specifically, in reference with official scientific literature, all double blind clinical trials on chronic neuropathic and oncologic pain in the advanced stage disease, clearly show that placebo effect is statistically relevant, but the extent is so mild to be substantially useless in pain relief.
In Scrambler Therapy, the relevance of operator-dependent variable and compliance to official treatment protocol guidelines has been undervalued for a long time. Success- rate variables in these cases can reach and exceed 40%, an absolutely very high percentage, unacceptable in reliable clinical trials or routine clinical practice. After having formalized this concern to the scientific community:
1) Inaccuracy in the article "Managing chronic pain: results from an open-label study ......". Support Care Cancer. 2011 Oct;19(10):1483-4. Epub 2011 Aug 2. PubMed PMID: 21808993,
2) Abdi S, Smith TJ, Marineo G. Letter to the Editor. Clin J Pain. 2014 Nov 3.[Epub ahead of print] PubMed PMID: 25370140.
All necessary solutions to minimize this operator-dependent variables have been identified and can be summarized in:
- Official free standard training course on the correct usage method.
- An official freely accessible information source (this site) on all needed information necessary to carry out unbiased clinical trials and verify guideline compliance.
- An always available telematics support for Scrambler Therapy users that provides tools to solve possible issues (STDM).
ST-NET project is based on ST-NET, an international automated network free for Scrambler Therapy users. This network has been set up for various purposes, but its main one is to support Clinical Trials and Pilot Centers in reducing to a minimum operator dependent variability results. By so doing, a quality system is created that regardless of clinical trials chosen by researchers, guarantees reproducibility and consistent results differently not achievable, therefore reliable scientific clinical trials.
ST-NET is focused on a clinical “intelligent” folder based on a dedicated software designed exclusively for Scrambler Therapy. Scrambler Therapy Data Manager, (STDM) software manages in a simple and effective way patients medical records in an easy to use visual database. During compilation, STDM automatically informs the operator of possible critical features, and suggests most fit treatment protocols for any patient and enables to use specific research tools such as Brief Pain Inventory, Pain Detect, DN4 and much more. This software can simultaneously (while you are working on the record) open patient's data on other traditional software such as Excel, Word or simply Notepad. It is also possible to analyze treatment trends with graphs that do not require previous configuration. The entire Database can be exported in standard formats with filtering criteria based on data, pain type or other meaningful characteristics in clinical trials.
By clicking on “Automatic analysis” an algorithm analyzes the treatment data and highlights the main control parameters, indicating the percentage shift from the normal values.Meaningful shifts or serious anomalies are highlighted.
The software is automatically connected to ST-NET. When necessary it sends in just a couple seconds and little PC and network commitment, completely anonymous 128 bit encrypted data. This data is collected in an International Hub, and becomes a shared reference knowledge. Data collected in the International Hub is automatically analyzed by an algorithm that detects possible treatment mistakes. If in your country there is a local authorized training facility, you will quickly receive free consultancy to solve possible criticality in methodology implementation, non standard protocols, “complicated” patients, or other problem-solving support. If there is no local support in your country, you can receive help through Skype , or also email in solving minor issues.
Data sent over ST-NET network are rendered anonymous, and pertain exclusively to folders managed by STDM. No other data type belonging to the system where the software is installed (including information rendered available by the operating system) is analyzed or sent over the network.
Data protection for publications
Clinical trial data is intrinsically protected by being put together with all those of other countries in the same Database, therefore coupled with anonymous patient data, they loose their feature of main and exclusive source. However, when you open a patient medical record in STDM you can easily add the confidentiality feature by ticking on a specific option. By so doing your research data is automatically sent into a secondary Hub and frozen for the selected time span (0 to 5 years), that can be extended just via email.
If you include ST-NET use in the protocol to be approved by the Ethical Committee/IRB as a quality and reproducible support system for clinical trials underway, you can establish within the protocol itself further constraints deemed necessary for data protection, together with approved monitoring on protocol compliance to Scrambler Therapy guidelines. You will receive a formal acknowledgement on correct methodology implementation in clinical trials, and optimization on unbiased research that in some past publications has led to partially unreliable data. The issue of unreliable data from general official guidelines that you can find in this website has been documented by published scientific literature.
Currently, ST-NET and standard official training represents the most updated methodology solution to develop high quality reproducible clinical trials, generating methodology-reliable scientific data to compensate for the operator-dependent variable.
ST-NET from its international activation, together with primary international training courses for clinical researchers and trainers (held without cost by Prof. Giuseppe Marineo) in Italy or secondary training specifically for Scrambler Therapy users, held in Italy and other countries by certified trainers, are the official golden standard acknowledged to be used as a quality and reproducibility system in Scrambler Therapy clinical research .